National Health Act 1953 - Determinations under sections 85, 85A and 88 (No. PB 47 of 2006) - Legislation

Determinations under sections 85,
85A and 88 (No. PB 47 of 2006)

as amended

made under the

National Health Act 1953

This compilation was prepared on 1 February 2007
taking into account amendments up to No. PB 6 of 2007

Prepared by the Office of Legislative Drafting and Publishing,
Attorney-General’s Department, Canberra

Pharmaceutical Benefits

Determinations under sections 85, 85A and 88

No. PB 47 of 2006 [see Note 1]

These Determinations commence on 1 December 2006.

2. The Determinations (No. PB 40 of 2006) under sections 85, 85A and 88 of the National Health Act 1953 made on 21 September 2006 with effect from 1 October 2006 are repealed.

3. In these Determinations:

“Act” means the National Health Act 1953;

“base-priced drug” means —

(a) in relation to cimetidine hydrochloride or ranitidine hydrochloride (tablet, effervescent, equivalent to 150 mg ranitidine or syrup equivalent to 150 mg ranitidine per 10 mL, 300 mL): cimetidine or famotidine or nizatidine or ranitidine hydrochloride (tablet equivalent to 150 mg ranitidine or tablet equivalent to 300 mg ranitidine); or

(b) in relation to amlodipine besylate or lercanidipine hydrochloride or nifedipine (tablet 20 mg (controlled release)): felodipine or nifedipine (tablet 10 mg or tablet 20 mg or tablet 30 mg (controlled release) or tablet 60 mg (controlled release)); or

(c) in relation to ramipril (pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg): captopril or enalapril maleate or fosinopril sodium or lisinopril or perindopril arginine or perindopril erbumine or quinapril hydrochloride or ramipril (tablet 1.25 mg or tablet 2.5 mg or tablet 5 mg or capsule 10 mg) or trandolapril;

“CFC” means chlorofluorocarbon;

“CFU” means colony forming unit;

“electronic communication” has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999;

“g” means gram;

“I.M.” means intramuscular;

“I.U.” means international unit;

“I.V.” means intravenous;

“kg” means kilogram;

“L” means litre;

“m” means metre;

“Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;

“mg” means milligram;

“mL” means millilitre;

“mm” means millimetre;

“mmol” means millimole;

“palliative care patient”, in relation to a purpose specified in Part 2 of the Second Schedule to these Determinations, means a patient with an active, progressive, far-advanced disease, and for whom the prognosis is limited and the focus of care is the quality of life;

“PBS” means Pharmaceutical Benefits Scheme;

“Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.

4. For the purposes of subsection 85(3) of the Act, where the strength, type of unit, size of unit or other particulars of form are specified in the column headed “Form” in the First or Second Schedule to these Determinations in relation to a drug or medicinal preparation referred to in subsection 85(2) of the Act the name of which is specified in that Schedule, those particulars refer to the form or forms of the drug or medicinal preparation that is or are allowable for the purposes of Part VII of the Act to the effect that the drug or medicinal preparation in that form or in each of those forms is a pharmaceutical benefit when prescribed by a medical practitioner.

4A. For the purposes of subsection 85(3) of the Act, where a form is specified in the column headed “Form” in the Fourth Schedule to these Determinations, that particular refers to the form of a medicinal preparation, which is composed of one or more of the drugs or medicinal preparations specified in Schedule 4 to the Declaration under subsection 85(2) of the Act with or without the addition of one or more of the substances specified in Schedule 5 to that Declaration, that is allowable for the purposes of Part VII of the Act to the effect that the medicinal preparation in that form is a pharmaceutical benefit when prescribed by a medical practitioner.

5. For the purposes of subsection 88(1A) of the Act, where the strength, type of unit, size of unit or other particulars of form are specified in the column headed “Form” in the Third Schedule to these Determinations in relation to a drug or medicinal preparation referred to in subsection 85(2) of the Act the name of which is specified in that Schedule, those particulars refer to the form or forms of the drug or medicinal preparation that is or are allowable for the purposes of Part VII of the Act to the effect that the drug or medicinal preparation in that form or in each of those forms is a pharmaceutical benefit referred to in subsection 88(1A) of the Act for the supply of which a participating dental practitioner is authorised to write a prescription.

6. The purposes set out in the column headed “Purposes” in Part 2 of the First or Second Schedule to these Determinations are the only purposes for which a medical practitioner may prescribe the maximum quantities and numbers of repeats specified in that Part in relation to those pharmaceutical benefits specified in that same Part.

7. The purposes set out in the column headed “Purposes” in Part 2 of the Third Schedule to these Determinations are the only purposes for which a participating dental practitioner may prescribe the maximum quantities specified in that Part in relation to those pharmaceutical benefits specified in that same Part.

8. For the purposes of subsection 85A(2)(c) of the Act, the manner of administration, if any, set out in the column headed “Manner of administration” in relation to a pharmaceutical benefit, the name of which is specified in:

(a) the First or Second Schedule to these Determinations, is the only manner in which a medical practitioner may, in a prescription, direct the pharmaceutical benefit to be administered; or

(b) the Third Schedule to these Determinations, is the only manner in which a participating dental practitioner may, in a prescription, direct the pharmaceutical benefit to be administered.

9. For the purposes of subsection 85A(2)(a) of the Act, the maximum quantity or number of units of a pharmaceutical benefit that may, in one prescription, be directed to be supplied on any one occasion is:

(a) where the name of the pharmaceutical benefit is specified —

(i) in Part 1 of the First Schedule to these Determinations — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical benefit; or

(ii) in Part 2 of the First Schedule to these Determinations and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical benefit; or

(iii) in Part 1 of the Second Schedule to these Determinations — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical benefit; or

(iv) in Part 2 of the Second Schedule to these Determinations and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical benefit; or

(v) in Part 1 of the Third Schedule to these Determinations — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical benefit; or

(vi) in Part 2 of the Third Schedule to these Determinations and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum quantity” in relation to the pharmaceutical benefit; or

(b) in any other case — the quantity or number, if any, specified in the column headed “Maximum quantity” in the Fourth Schedule to these Determinations in relation to the form of the pharmaceutical benefit.

10. For the purposes of subsection 85A(2)(b) of the Act, the maximum number of occasions, if any, on which the supply of a pharmaceutical benefit may, in one prescription, be directed by a medical practitioner to be repeated is:

(a) where the name of the pharmaceutical benefit is specified —

(i) in Part 1 of the First Schedule to these Determinations — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or

(ii) in Part 2 of the First Schedule to these Determinations and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or

(iii) in Part 1 of the Second Schedule to these Determinations — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or

(iv) in Part 2 of the Second Schedule to these Determinations and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or

(b) in any other case — the number, if any, specified in the column headed “Maximum number of repeats” in the Fourth Schedule to these Determinations in relation to the form of the pharmaceutical benefit.

11. The following purposes are specified in relation to each pharmaceutical benefit the name of which is specified in Part 2 of the First or Second Schedule to these Determinations:

(a) where a class of persons is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;

(b) where a disease or condition is specified in the column headed “Purposes” —

(i) if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or

(ii) if the disease or condition is specified in relation to a specified class of persons — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in a person included in that class of persons;

(c) where a purpose is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for that purpose;

(d) where it is specified in the column headed “Purposes” that compliance with authority procedures set out in subparagraph 11(d) is required — that a medical practitioner has submitted to the Medicare Australia CEO a prescription for the supply of the pharmaceutical benefit:

(i) by preparing and signing the prescription:

(A) in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or

(B) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubsubparagraph (A); or

(C) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or

(D) by a method approved in writing by the Secretary; or

(ii) by submitting the prescription by giving the Medicare Australia CEO by telephone, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i); or

(iii) where the medical practitioner has attempted to obtain an authorisation by submitting details of the prescription to the Medicare Australia CEO in accordance with subsubparagraph (ii) but has been unable to do so because of a failure or other form of unavailability in the telephone system established by the Medicare Australia CEO for the provision of such authorisations, by submitting the prescription in accordance with the instructions stipulated in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO; or

(iv) by submitting the prescription by giving the Medicare Australia CEO, by means of an electronic communication of a kind approved in writing by the Medicare Australia CEO, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subsubparagraph (i).

11A. For the purposes of subsubparagraph 11(d)(i), a prescription that has been prepared and signed by the medical practitioner in accordance with that subparagraph is taken to have been submitted by him or her if it is submitted by one of his or her employees.

12. Subject to paragraph 12B, the authorisation of a prescription submitted under subparagraph 11(d) may be made:

(a) if the prescription was submitted in accordance with subsubparagraph 11(d)(i) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:

(i) if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or

(ii) in any other case:

(A) by returning it to the medical practitioner; or

(B) by sending it to the person in respect of whom it was prepared; or

(b) if the prescription was submitted in accordance with subsubparagraph 11(d)(ii) — orally, at the time the Medicare Australia CEO is given details of the prescription; or

(c) if the prescription was submitted in accordance with subsubparagraph 11(d)(iv) — by the Medicare Australia CEO sending his or her authorisation, by electronic communication, to the medical practitioner.

12A. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 12(b) or (c):

(a) the Medicare Australia CEO must tell the medical practitioner, orally or by electronic communication, the number that has been allotted to the authorised prescription; and

(b) the medical practitioner must:

(i) mark that number on the prescription; and

(ii) retain a copy of the prescription for 1 year from the date on which the prescription was authorised.

12B. Notwithstanding paragraph 12, if the prescription was submitted in accordance with subsubparagraph 11(d)(iii), authorisation shall be deemed to have been granted upon completion by the medical practitioner of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.

12C. Where a prescription is authorised, or deemed to be authorised, in accordance with paragraph 12, and an authorisation is also granted in accordance with subregulation 13(5) of the Regulations increasing the maximum quantity or number of units of the pharmaceutical benefit that may, in the prescription, be directed to be supplied on any one occasion, or the maximum number of occasions on which the supply of the pharmaceutical benefit may, in the prescription, be directed to be repeated, the authorisation in accordance with paragraph 12 is taken to be for the prescription of the increased quantity, number, or occasions, as the case may be.

13. The following purposes are specified in relation to each pharmaceutical benefit the name of which is specified in Part 2 of the Third Schedule to these Determinations:

(a) where a class of persons is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for the treatment of a person included in that class of persons;

(b) where a disease or condition is specified in the column headed “Purposes” —

(i) if subsubparagraph (ii) does not apply — that the pharmaceutical benefit is to be supplied for the treatment of that disease or condition in relation to any person; or

(c) where a purpose is specified in the column headed “Purposes” — that the pharmaceutical benefit is to be supplied for that purpose.

14. For the purposes of subsection 85(6) of the Act, the name of the manufacturer or the names of manufacturers denoted in accordance with the following table by letters appearing in the column headed “Brand” in the First, Second or Third Schedule to these Determinations in relation to a drug or medicinal preparation the name of which is specified in that Schedule is or are the brand or brands under which the drug or medicinal preparation may be supplied under Part VII of the Act as a pharmaceutical benefit:

Letters

Manufacturer's Name

Letters

Manufacturer's Name

AB	Abbott Australasia Pty Ltd
AE	AFT Pharmaceuticals Pty Limited
AF	Alphapharm Pty Limited
AG	Allergan Australia Pty Ltd
AH	Altana Pharma Pty Ltd
AL	Alphapharm Medical A Division of Alphapharm Pty Limited
AN	Amgen Australia Pty Ltd
AP	AstraZeneca Pty Ltd
AQ	Alcon Laboratories (Australia) Pty Ltd
AS	Aspen Pharmacare Australia Pty Ltd
AV	Aventis Pharma Pty Limited
AW	Arrow Pharmaceuticals Pty Limited
AX	Sanofi Pasteur Pty Limited
BC	Bristol Laboratories A Division of Bristol-Myers Squibb Australia Pty Ltd
BD	Biogen Idec Australia Pty Ltd
BF	Bellwether Pharma Limited
BG	Biochemie Australia A Division of Sandoz Pty Ltd
BN	Bayer Australia Limited
BP	British Pharmaceuticals
BQ	Bristol-Myers Squibb Pharmaceuticals A Division of Bristol-Myers Squibb Australia Pty Ltd
BR	B. Braun Australia Pty Ltd
BU	Bausch & Lomb Surgical A Division of Bausch & Lomb (Australia) Pty Ltd
BX	Baxter Healthcare Pty Limited
BY	Boehringer Ingelheim Pty Limited
CF	CNS Pharma Pty Ltd
CH	Chem mart Pty Limited
CO	Chemists' Own Pty Ltd A member of Sigma Group of Companies
CS	CSL Limited
CX	Contact Lens Centre Australia Pty Ltd
DK	Dakota Pharmaceuticals A Division of Sanofi-Synthelabo Australia Pty Limited
DN	Digiland Pty Ltd
DR	DiaCare International Pty Ltd
DT	DermaTech Laboratories Pty Ltd
EO	Ego Pharmaceuticals Pty Ltd
EP	EpiPharm Pty Ltd
ES	EBOS Group Pty Ltd
EX	Essex Laboratories
FA	F.H. Faulding & Co. Limited
FB	Pierre Fabre Medicament Australia Pty Limited
FL	C. B. Fleet Co. (Aust.) Pty Ltd
FM	Fawns and McAllan Pty Ltd A member of Sigma Group of Companies
FP	Ferring Pharmaceuticals Pty Ltd
FR	Charles E. Frosst Division of Merck Sharp & Dohme (Australia) Pty Ltd
GC	GlaxoSmithKline Consumer Healthcare
GD	General Diabetes Services
GH	Goldshield Healthcare (Australia) Pty Ltd
GK	GlaxoSmithKline Australia Pty Ltd
GM	Genepharm Pty Ltd
GN	Genepharm Australasia Limited
GP	GP Laboratories A Division of Pfizer Pty Limited
GX	GenRx Pty Ltd
HA	Hamilton Laboratories Pty Ltd
HP	Hoechst Division of Aventis Pharma Pty Limited
HX	Hexal Australia Pty Ltd
IQ	Ioquin A Division of Alcon Laboratories (Australia) Pty Ltd
IT	InterPharma Pty Ltd
IZ	Intensive Care Products Pty Ltd
JC	Janssen-Cilag Pty Ltd
JT	Johnson & Johnson Pacific Pty Limited
KN	Knoll A Division of Abbott Australasia Pty Ltd
KR	Kenral Division of Pharmacia Australia Pty Limited
KY	Key Pharmaceuticals Pty Ltd
LB	Life Bioscience Pty Ltd
LF	Laboratoires Fournier S.A.
LM	Link Medical Products Pty Ltd
LN	Lennon Healthcare A Division of Aspen Pharmacare Australia Pty Ltd
LU	Lundbeck Australia Pty Ltd
LY	Eli Lilly Australia Pty Limited
MD	Macarthur Research Division of Roche Products Pty Ltd
ME	Menley & James Division of GlaxoSmithKline Australia Pty Ltd
MF	Mundipharma Pty Ltd
MK	Merck Sharp & Dohme (Australia) Pty Ltd
ML	Marion Division of Aventis Pharma Pty Limited
MM	3M Pharmaceuticals Australia Pty Ltd
MQ	Merck Pharmaceuticals
MS	Abbott Diagnostics Division (MediSense Products)
MX	Mayne Pharma Pty Ltd
NA	National Diagnostic Products (Aust) Pty Limited
NE	Norgine Pty Limited
NF	FlexPen Products of Novo Nordisk Pharmaceuticals Pty Ltd
NI	InnoLet Products of Novo Nordisk Pharmaceuticals Pty Ltd
NL	NovoLet Products of Novo Nordisk Pharmaceuticals Pty Ltd
NM	Novartis Medicines A Division of Novartis Pharmaceuticals Australia Pty Ltd
NO	Novo Nordisk Pharmaceuticals Pty Ltd
NT	Nestlé Australia Ltd
NU	Nutricia Australia Pty Limited
NV	Novartis Pharmaceuticals Australia Pty Ltd
OA	Orphan Australia Pty Ltd
OR	Organon (Australia) Pty Limited
PC	Pfizer Consumer Healthcare Pty Ltd
PD	Parke Davis Pty Ltd
PE	Pacific EyeCare A Division of Allergan Australia Pty Ltd
PF	Pfizer Pty Limited
PH	Pharmacia Australia Pty Limited
PK	Pharmatel Fresenius Kabi Pty Ltd
PL	Pharmalab
PM	PMC Pharma A Division of AstraZeneca Pty Ltd
PP	Petrus Pharmaceuticals Pty Ltd
PU	Pharmacia & Upjohn Pty Limited
PX	Point of Care Diagnostics Australia Pty Ltd
QM	Qualimed Division of Aventis Pharma Pty Limited
RA	Ranbaxy Australia Pty Limited
RC	Reckitt Benckiser (Australia) Pty Limited
RD	Roche Diagnostics Australia Pty Ltd
RE	Real-RL Division of GlaxoSmithKline Australia Pty Ltd
RO	Roche Products Pty Ltd
SB	Scientific Hospital Supplies Australia Products
SC	Schering Pty Ltd Australian Subsidiary of Schering AG, Berlin
SE	Servier Laboratories (Aust.) Pty Ltd
SG	Serono Australia Pty Ltd
SH	Schering-Plough Pty Ltd
SI	Sigma Pharmaceuticals Pty Ltd
SJ	Sharpe Laboratories Pty Ltd
SL	SBPA A Division of Sandoz Pty Ltd
SM	Solvay Pharmaceuticals Division of Solvay Biosciences Pty Ltd
SN	Smith & Nephew Healthcare
SU	Sauter Laboratories (Aust.) Pty Ltd
SW	Sanofi-Synthelabo Australia Pty Limited
SY	Schering AG
SZ	Sandoz Pty Ltd
TM	Technipro Marketing Pty Ltd
TW	Terry White Chemists
UC	UCB Pharma A Division of UCB Australia Pty Ltd
VF	Vitaflo Australia Pty Ltd
VT	Valeant Pharmaceuticals Australasia Pty Ltd
WA	Winthrop Pharmaceuticals Division of Sanofi-Aventis Australia Pty Limited
WF	MedWatchDog Pty Limited
WT	Wyeth Consumer Healthcare Pty Ltd
WW	Wm R. Warner
WX	Wyeth Australia Pty Limited
WY	Wyeth Pharmaceuticals Division of Wyeth Australia Pty Limited

Abciximab	I.V. injection 10 mg in 5 mL vial	Injection	3	..	LY
Acamprosate Calcium	Tablet 333 mg (enteric coated)	Oral	180	1	AF
Acarbose	Tablet 50 mg	Oral	90	5	BN
	Tablet 100 mg	Oral	90	5	BN
Acetazolamide	Tablet 250 mg	Oral	100	3	SI
Acetylcysteine Sodium	Inhalation solution equivalent to 200 mg acetylcysteine per mL, 5 mL	Inhalation	30	3	BQ
Aciclovir	Tablet 200 mg	Oral	50	..	AF, GK, GM, GX, HX
	Tablet 800 mg	Oral	35	..	AF, GK, GM, GX, HX
	Eye ointment 30 mg per g, 4.5 g	Application to the eye	1	..	GK
Acitretin	Capsule 10 mg	Oral	100	2	RO
	Capsule 25 mg	Oral	100	2	RO
Adalimumab	Injection 40 mg in 0.8 mL pre-filled syringe	Injection	2	3	AB
Adrenaline	I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector	Injection	1	..	CS
	I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector	Injection	1	..	CS
Adrenaline Acid Tartrate	Injection equivalent to adrenaline 1 in 1,000, 1 mL	Injection	5	1	AP
Albendazole	Tablet 200 mg	Oral	6	..	GK
	Tablet 400 mg	Oral	60	2	GK
Alendronate Sodium	Tablet equivalent to 70 mg alendronic acid	Oral	4	5	AW, MK
	Tablet equivalent to 40 mg alendronic acid	Oral	30	5	MK
Alendronate Sodium with Colecalciferol	Tablet equivalent to 70 mg alendronic acid with 70 micrograms colecalciferol	Oral	4	5	MK
"Alfaré"	Oral powder 400 g	Oral	8	5	NT
Allopurinol	Tablet 100 mg	Oral	200	2	AF, CH, FM, GX, HX, SI, TW
	Tablet 300 mg	Oral	60	2	AF, CH, FM, GX, HX, SI, TW
Alprazolam	Tablet 250 micrograms	Oral	50	..	AF, AW, HX, PH
	Tablet 500 micrograms	Oral	50	..	AF, AW, HX, PH
	Tablet 1 mg	Oral	50	2	AF, AW, CH, GM, GX, HX, PH, TW
	Tablet 2 mg	Oral	50	2	AF, AW, CH, GM, GX, HX, PH, TW
Aluminium Hydroxide - Dried with Magnesium Hydroxide	Tablet 200 mg-200 mg Oral suspension 200 mg-200 mg per 5 mL, 500 mL	Oral Oral	200 2	5 5	PC, WW PC, WW
		Oral Oral	200 2	5 5	PC, WW PC, WW
Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide	Oral suspension 250 mg-120 mg-120 mg per 5 mL, 500 mL	Oral	2	5	FM
Amantadine Hydrochloride	Capsule 100 mg	Oral	100	5	NV
Amiloride Hydrochloride	Tablet 5 mg	Oral	100	1	AF
Aminoglutethimide	Tablet 250 mg	Oral	100	5	NV
Amiodarone Hydrochloride	Tablet 100 mg	Oral	30	5	AF, AW, GX, HX, SW
	Tablet 200 mg	Oral	30	5	AF, AW, CH, GX, HX, SW, TW
Amisulpride	Tablet 100 mg	Oral	30	5	SW
	Tablet 200 mg	Oral	60	5	SW
	Tablet 400 mg	Oral	60	5	SW
	Oral solution 100 mg per mL, 60 mL	Oral	2	5	SW
Amitriptyline Hydrochloride	Tablet 10 mg	Oral	50	2	AF
	Tablet 25 mg	Oral	50	2	AF
	Tablet 50 mg	Oral	50	2	AF
Amlodipine Besylate	Tablet equivalent to 5 mg amlodipine	Oral	30	5	PF
	Tablet equivalent to 10 mg amlodipine	Oral	30	5	PF
Amlodipine Besylate with Atorvastatin Calcium	Tablet equivalent to 5 mg amlodipine with 10 mg atorvastatin	Oral	30	5	PF
	Tablet equivalent to 5 mg amlodipine with 20 mg atorvastatin	Oral	30	5	PF
	Tablet equivalent to 5 mg amlodipine with 40 mg atorvastatin	Oral	30	5	PF
	Tablet equivalent to 5 mg amlodipine with 80 mg atorvastatin	Oral	30	5	PF
	Tablet equivalent to 10 mg amlodipine with 10 mg atorvastatin	Oral	30	5	PF
	Tablet equivalent to 10 mg amlodipine with 20 mg atorvastatin	Oral	30	5	PF
	Tablet equivalent to 10 mg amlodipine with 40 mg atorvastatin	Oral	30	5	PF
	Tablet equivalent to 10 mg amlodipine with 80 mg atorvastatin	Oral	30	5	PF
Amoxycillin Trihydrate	Tablet, chewable, equivalent to 250 mg amoxycillin	Oral	20	1	GK
	Tablet equivalent to 1 g amoxycillin	Oral	14	1	BG, GK, SZ
	Capsule equivalent to 250 mg amoxycillin	Oral	20	1	AF, CH, CS, GK, GM, GX, HX, SI, TW
	Capsule equivalent to 500 mg amoxycillin	Oral	20	1	AF, CH, CS, GK, GM, GX, HX, SI, TW
	Sachet containing oral powder equivalent to 3 g amoxycillin	Oral	1	..	GK
Amoxycillin Trihydrate with Potassium Clavulanate	Tablet equivalent to 500 mg amoxycillin-125 mg clavulanic acid	Oral	10	1	AL, GK, HX, ME, SL, SZ
	Tablet equivalent to 875 mg amoxycillin-125 mg clavulanic acid	Oral	10	1	AL, CH, GK, GX, HX, ME, SL, SZ, TW
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP	Powder for oral suspension equivalent to 125 mg amoxycillin-31.25 mg clavulanic acid per 5 mL, 75 mL	Oral	1	1	AL, GK, HX, ME
	Powder for oral suspension equivalent to 400 mg amoxycillin-57 mg clavulanic acid per 5 mL, 60 mL	Oral	1	1	AL, GK, HX, ME
Amoxycillin Trihydrate with Water - Purified BP	Powder for paediatric oral drops equivalent to 100 mg amoxycillin per mL, 20 mL	Oral	1	1	GK
	Powder for oral suspension equivalent to 125 mg amoxycillin per 5 mL, 100 mL	Oral	1	1	AF, CH, CS, GK, GM, GX, HX, TW
	Powder for oral suspension equivalent to 250 mg amoxycillin per 5 mL, 100 mL	Oral	1	1	AF, CH, GK, GM, GX, HX, SI, TW
	Powder for oral suspension equivalent to 500 mg amoxycillin per 5 mL, 100 mL	Oral	1	1	SZ
Amphotericin	Lozenge 10 mg	Oral	20	1	BQ
	Powder for injection 50 mg	Injection	1	..	BQ
Ampicillin Sodium	Powder for injection equivalent to 500 mg ampicillin	Injection	5	1	GM, LN
	Powder for injection equivalent to 1 g ampicillin	Injection	5	1	AS, GM, LN
Ampicillin Trihydrate	Capsule equivalent to 250 mg ampicillin	Oral	24	1	AF
	Capsule equivalent to 500 mg ampicillin	Oral	24	..	AF
Anakinra	Injection 100 mg in 0.67 mL single use pre-filled syringe	Injection	28	3	AN
Anastrozole	Tablet 1 mg	Oral	30	5	AP
Apraclonidine Hydrochloride	Eye drops equivalent to 5 mg apraclonidine per mL, 10 mL	Application to the eye	1	2	AQ
Aprepitant	Pack containing 1 capsule 125 mg and 2 capsules 80 mg	Oral	1	..	MK
Aripiprazole	Tablet 10 mg	Oral	30	5	BQ
	Tablet 15 mg	Oral	30	5	BQ
	Tablet 20 mg	Oral	30	5	BQ
	Tablet 30 mg	Oral	30	5	BQ
Aspirin	Tablet 100 mg	Oral	112	1	FA, MX
	Tablet, dispersible, 300 mg	Oral	96	1	RC
Atenolol	Tablet 50 mg	Oral	30	5	AF, AP, CH, GM, GX, SI, SZ, TW
Atorvastatin Calcium	Tablet equivalent to 10 mg atorvastatin	Oral	30	5	PF
	Tablet equivalent to 20 mg atorvastatin	Oral	30	5	PF
	Tablet equivalent to 40 mg atorvastatin	Oral	30	5	PF
	Tablet equivalent to 80 mg atorvastatin	Oral	30	5	PF
Atovaquone	Oral suspension 750 mg per 5 mL, 210 mL	Oral	1	..	GK
Atropine Sulfate	Injection 600 micrograms in 1 mL ampoule	Injection	10	1	AP
	Eye drops 10 mg per mL, 15 mL	Application to the eye	1	2	SI
Auranofin	Tablet 3 mg	Oral	60	5	GH
Azathioprine	Tablet 25 mg	Oral	100	2	GK, HX
	Tablet 50 mg	Oral	100	2	AF, AW, GK, GM, GX, HX
Azithromycin Dihydrate	Tablet equivalent to 500 mg azithromycin	Oral	2	..	PF
Azithromycin Dihydrate with Water - Purified BP	Powder for oral suspension equivalent to 200 mg azithromycin per 5 mL, 15 mL	Oral	1	..	PF
Baclofen	Tablet 10 mg	Oral	100	5	AF, AW, CH, GM, GX, HX, NV, TW
	Tablet 25 mg	Oral	100	5	AF, AW, CH, GM, GX, HX, NV, TW
Balsalazide Sodium	Capsule 750 mg	Oral	180	5	PK
"BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain)	Single dose set comprising 1 vial powder for intravesical administration containing 6.6 to 19.2 x 108 CFU and 1 vial diluent 3 mL	Intravesical administration	3	1	AV
"BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain)	Vial containing powder for intravesical administration approximately 5 x 108 CFU	Intravesical administration	3	1	OR
Beclomethasone Dipropionate	Pressurised inhalation 50 micrograms per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	1	5	MM
	Pressurised inhalation 100 micrograms per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	1	5	MM
	Pressurised inhalation in breath actuated device 50 micrograms per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	1	5	MM
	Pressurised inhalation in breath actuated device 100 micrograms per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	1	5	MM
Benzathine Penicillin	Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector)	Injection	1	..	AS
	Powder for injection 900 mg	Injection	1	..	AS
Benzhexol Hydrochloride	Tablet 2 mg	Oral	200	2	SI
	Tablet 5 mg	Oral	200	1	SI
Benztropine Mesylate	Tablet 2 mg	Oral	60	2	PL
	Injection 2 mg in 2 mL ampoule	Injection	5	..	MK
Benzydamine Hydrochloride	Mouth and throat rinse 22.5 mg per 15 mL, 500 mL	Oral application	1	1	MM
Benzylpenicillin Sodium	Powder for injection equivalent to 600 mg benzylpenicillin	Injection	10	1	CS
	Powder for injection equivalent to 3 g benzylpenicillin	Injection	10	..	CS
Betamethasone Acetate with Betamethasone Sodium Phosphate	Injection 3 mg-3.9 mg in 1 mL ampoule	Injection	5	..	SH
Betamethasone Dipropionate	Cream equivalent to 500 micrograms betamethasone per g, 15 g	Application	1	1	EX, SH
	Ointment equivalent to 500 micrograms betamethasone per g, 15 g	Application	1	1	EX, SH
Betamethasone Valerate	Cream equivalent to 200 micrograms betamethasone per g, 100 g	Application	2	..	EX, FM, SH, SI
	Cream equivalent to 500 micrograms betamethasone per g, 15 g	Application	1	1	FM, SI
	Ointment equivalent to 200 micrograms betamethasone per g, 100 g	Application	2	..	EX, SH
	Ointment equivalent to 500 micrograms betamethasone per g, 15 g	Application	1	1	FM, SI
Betaxolol Hydrochloride	Eye drops, suspension, equivalent to 2.5 mg betaxolol per mL, 5 mL	Application to the eye	1	5	AQ
	Eye drops, solution, equivalent to 5 mg betaxolol per mL, 5 mL	Application to the eye	1	5	AQ, IQ
Bethanechol Chloride	Tablet 10 mg	Oral	100	2	HA
Bicalutamide	Tablet 50 mg	Oral	28	5	AP
Bifonazole	Cream 10 mg per g, 15 g	Application	2	3	BN
Bimatoprost	Eye drops 300 micrograms per mL, 3 mL	Application to the eye	1	5	AG
Biperiden Hydrochloride	Tablet 2 mg	Oral	200	2	AB
Bisacodyl	Tablet 5 mg	Oral	200	2	AE, AS
	Suppositories 10 mg, 10	Rectal	3	5	BY, PP
	Suppositories 10 mg, 12	Rectal	3	4	FL, PP
	Enemas 10 mg in 5 mL, 25	Rectal	1	2	AS
Bisoprolol Fumarate	Tablet 2.5 mg	Oral	28	5	AL
	Tablet 5 mg	Oral	28	5	AL
	Tablet 10 mg	Oral	28	5	AL
Bivalirudin Trifluoroacetate	Powder for I.V. injection equivalent to 250 mg bivalirudin, vial	Injection	1	..	CS
Bleomycin Sulfate with any determined brand of Sodium Chloride Injection	Powder for injection 15,000 I.U. (with required solvent)	Injection	10	..	BQ, MX, SI
Brimonidine Tartrate	Eye drops 2 mg per mL, 5 mL	Application to the eye	1	5	AG, PE
Brimonidine Tartrate with Timolol Maleate	Eye drops 2 mg brimonidine tartrate with timolol maleate equivalent to 5 mg timolol per mL, 5 mL	Application to the eye	1	5	AG
Brinzolamide	Eye drops 10 mg per mL, 5 mL	Application to the eye	1	5	AQ, IQ
Bromocriptine Mesylate	Tablet equivalent to 2.5 mg bromocriptine	Oral	30	..	AF, NV
	Capsule equivalent to 5 mg bromocriptine	Oral	60	5	AF, NV
	Capsule equivalent to 10 mg bromocriptine	Oral	100	5	AF, NV
Budesonide	Nebuliser suspension 500 micrograms in 2 mL single dose units, 30	Inhalation	1	5	AP
	Nebuliser suspension 1 mg in 2 mL single dose units, 30	Inhalation	1	5	AP
	Powder for oral inhalation in breath actuated device 100 micrograms per dose, 200 doses	Inhalation by mouth	1	5	AP
	Powder for oral inhalation in breath actuated device 200 micrograms per dose, 200 doses	Inhalation by mouth	1	5	AP
	Powder for oral inhalation in breath actuated device 400 micrograms per dose, 200 doses	Inhalation by mouth	1	5	AP
Budesonide with Eformoterol Fumarate Dihydrate	Powder for oral inhalation in breath actuated device 100 micrograms-6 micrograms per dose, 120 doses	Inhalation by mouth	1	5	AP
	Powder for oral inhalation in breath actuated device 200 micrograms-6 micrograms per dose, 120 doses	Inhalation by mouth	1	5	AP
	Powder for oral inhalation in breath actuated devices 400 micrograms-12 micrograms per dose, 60 doses, 2	Inhalation by mouth	1	5	AP
Buprenorphine	Transdermal patch 5 mg	Transdermal	2	..	MF
	Transdermal patch 10 mg	Transdermal	2	..	MF
	Transdermal patch 20 mg	Transdermal	2	..	MF
Bupropion Hydrochloride	Tablet 150 mg (sustained release)	Oral	30	..	GK, HX, RE
Busulfan	Tablet 2 mg	Oral	100	..	GK
Cabergoline	Tablet 500 micrograms	Oral	2	..	PH
	Tablet 1 mg	Oral	30	5	PU
	Tablet 2 mg	Oral	30	5	PU
	Tablet 4 mg	Oral	30	5	PU
Calcipotriol	Ointment 50 micrograms per g, 30 g	Application	1	1	CS
Calcitriol	Capsule 0.25 microgram	Oral	100	3	AF, AL, AW, GM, GX, HX, RO
Calcium Carbonate	Tablet, chewable, 1.25 g (equivalent to 500 mg calcium)	Oral	120	1	MM
	Tablet 1.5 g (equivalent to 600 mg calcium)	Oral	120	1	WT
Calcium Citrate	Tablet equivalent to 250 mg calcium	Oral	120	1	KY
Calcium Folinate	Tablet equivalent to 15 mg folinic acid	Oral	10	..	MX
	Injection equivalent to 50 mg folinic acid in 5 mL	Injection	5	5	IT, MX, PF
	Injection equivalent to 100 mg folinic acid in 10 mL	Injection	10	1	IT, PF
	Injection equivalent to 300 mg folinic acid in 30 mL	Injection	4	1	MX
Candesartan Cilexetil	Tablet 4 mg	Oral	30	5	AP
	Tablet 8 mg	Oral	30	5	AP
	Tablet 16 mg	Oral	30	5	AP
	Tablet 32 mg	Oral	30	5	AP
Candesartan Cilexetil with Hydrochlorothiazide	Tablet 16 mg-12.5 mg	Oral	30	5	AP
Capecitabine	Tablet 150 mg	Oral	60	2	RO
	Tablet 500 mg	Oral	120	2	RO
"Caprilon"	Oral powder 420 g	Oral	8	5	SB
Captopril	Tablet 12.5 mg	Oral	90	5	AF, BQ, CH, FM, GM, GX, HX, TW
	Tablet 25 mg	Oral	90	5	AF, BQ, CH, FM, GM, GX, HX, TW
	Tablet 50 mg	Oral	90	5	AF, BQ, CH, FM, GM, GX, HX, TW
	Oral solution 5 mg per mL, 95 mL	Oral	1	5	BQ
Carbamazepine	Tablet 100 mg	Oral	200	2	BG, NV, SZ
	Tablet 200 mg	Oral	200	2	AF, BG, NV, SZ
	Tablet 200 mg (controlled release)	Oral	200	2	NV
	Tablet 400 mg (controlled release)	Oral	200	2	NV
	Oral suspension 100 mg per 5 mL, 300 mL	Oral	1	5	NV
Carbimazole	Tablet 5 mg	Oral	200	2	RO
"Carbohydrate Free Mixture"	Oral powder 225 g	Oral	24	5	SB
Carbomer 974	Ocular lubricating gel 3 mg per g, single dose units 0.5 g, 30	Application to the eye	3	5	AQ
Carbomer 980	Ocular lubricating gel 2 mg per g, 10 g	Application to the eye	1	5	BU, NM, NV
	Eye drops 2 mg per g, single dose units 0.6 mL, 30	Application to the eye	3	5	NV
Carboplatin	Solution for I.V. injection 50 mg in 5 mL	Injection	2	..	IT, MX, PU
	Solution for I.V. injection 150 mg in 15 mL	Injection	6	..	IT, MX, PU
	Solution for I.V. injection 450 mg in 45 mL	Injection	2	..	IT, MX, PU
Carmellose Sodium	Eye drops 5 mg per mL, 15 mL	Application to the eye	1	5	AG
	Eye drops 10 mg per mL, 15 mL	Application to the eye	1	5	AG
	Eye drops 2.5 mg per mL, single dose units 0.6 mL, 24	Application to the eye	4	5	CX
	Eye drops 5 mg per mL, single dose units 0.4 mL, 30	Application to the eye	3	5	AG
	Eye drops 10 mg per mL, single dose units 0.4 mL, 30	Application to the eye	3	5	AG
	Ocular lubricating gel 10 mg per mL, single dose units 0.6 mL, 28	Application to the eye	3	5	CX
Carmustine	Implants 7.7 mg, 8	Intracranial	1	..	OA
Carvedilol	Tablet 3.125 mg	Oral	30	..	GX, MD, RO
	Tablet 6.25 mg	Oral	60	5	GX, MD, RO
	Tablet 12.5 mg	Oral	60	5	GX, MD, RO
	Tablet 25 mg	Oral	60	5	GX, MD, RO
Cefaclor Monohydrate	Tablet (sustained release) equivalent to 375 mg cefaclor	Oral	10	1	AF, AS, CH, GM, GX, LN, RA, TW
Cefaclor Monohydrate with Water - Purified BP	Powder for oral suspension equivalent to 125 mg cefaclor per 5 mL, 100 mL	Oral	1	1	AF, AS, AW, CH, GX, TW
	Powder for oral suspension equivalent to 250 mg cefaclor per 5 mL, 75 mL	Oral	1	1	AF, AS, AW, CH, GX, TW
Cefepime Hydrochloride with any determined brand of Sodium Chloride Injection		Powder for injection equivalent to 1 g cefepime (with required solvent)	Injection	10	..	BQ
		Powder for injection equivalent to 2 g cefepime (with required solvent)	Injection	10	..	BQ
Cefotaxime Sodium	Powder for injection equivalent to 1 g cefotaxime	Injection	10	..	MX, SZ
	Powder for injection equivalent to 2 g cefotaxime	Injection	10	..	MX, SZ
Ceftriaxone Sodium	Powder for injection equivalent to 500 mg ceftriaxone	Injection	1	..	IZ
	Powder for injection equivalent to 1 g ceftriaxone	Injection	5	..	IZ, MX, RO, SZ
	Powder for injection equivalent to 2 g ceftriaxone	Injection	5	..	IZ, MX, RO, SZ
Cefuroxime Axetil	Tablet equivalent to 250 mg cefuroxime	Oral	14	1	GK
Celecoxib	Capsule 100 mg	Oral	60	3	PH
	Capsule 200 mg	Oral	30	3	PH
Cephalexin	Capsule 250 mg (anhydrous)	Oral	20	1	AF, AS, CH, GM, GX, HX, LN, RA, TW
	Capsule 500 mg (anhydrous)	Oral	20	1	AF, AS, CH, GM, GX, HX, LN, RA, TW
Cephalexin with Water - Purified BP	Granules for oral suspension 125 mg per 5 mL, 100 mL	Oral	1	1	AF, AS, CH, GM, GX, LN, TW
	Granules for oral suspension 250 mg per 5 mL, 100 mL	Oral	1	1	AF, AS, CH, GM, GX, LN, TW
Cephalothin Sodium	Powder for injection equivalent to 1 g cephalothin	Injection	10	1	AS, MX
Cephazolin Sodium	Powder for injection equivalent to 500 mg cephazolin	Injection	10	..	MX
	Powder for injection equivalent to 1 g cephazolin	Injection	10	..	AS, MX, SZ
Chlorambucil	Tablet 2 mg	Oral	100	2	GK
Chloramphenicol	Ear drops (aqueous) 5 mg per mL, 5 mL	Application to the ear	1	2	PF
	Eye drops 5 mg per mL, 10 mL	Application to the eye	1	2	PF, SI
	Eye ointment 10 mg per g, 4 g	Application to the eye	1	..	PF, SI
Chlorpromazine Hydrochloride	Tablet 10 mg	Oral	100	5	AV
	Tablet 25 mg	Oral	100	5	AV
	Tablet 100 mg	Oral	100	5	AV
	Oral solution 25 mg per 5 mL, 100 mL	Oral	1	5	AV
	Injection 50 mg in 2 mL ampoule	Injection	10	..	AV
Chlorthalidone	Tablet 25 mg	Oral	100	1	NV
Cholestyramine	Sachets containing 4.7 g oral powder (equivalent to 4 g cholestyramine), 50	Oral	2	5	BQ
	Sachets containing 9.4 g oral powder (equivalent to 8 g cholestyramine), 50	Oral	1	5	BQ
Chorionic Gonadotrophin	Injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL	Injection	1	5	OR
	Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL	Injection	1	5	OR
Ciclesonide	Pressurised inhalation 80 micrograms per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	1	5	AH
	Pressurised inhalation 160 micrograms per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	1	5	AH
Cimetidine	Tablet 200 mg	Oral	120	5	AF, GK
	Tablet 400 mg	Oral	60	5	AF, GK, GX
	Tablet 800 mg	Oral	30	5	AF, GX
Ciprofloxacin Hydrochloride	Tablet equivalent to 500 mg ciprofloxacin	Oral	14	..	AL, AW, BG, BN, GM, GN, GX, HX
	Tablet equivalent to 750 mg ciprofloxacin	Oral	14	..	AL, AW, BN, GM, GN, GX, HX
	Tablet equivalent to 250 mg ciprofloxacin	Oral	2	..	BN
Ciprofloxacin Hydrochloride	Ear drops equivalent to 3 mg ciprofloxacin per mL, 5 mL	Application to the ear	1	1	AQ
	Eye drops equivalent to 3 mg ciprofloxacin per mL, 5 mL	Application to the eye	2	..	AQ, IQ
Cisplatin	I.V. injection 10 mg in 10 mL	Injection	1	..	PU
	I.V. injection 50 mg in 50 mL	Injection	1	..	MX, PU
	I.V. injection 100 mg in 100 mL	Injection	1	..	IT, MX
Citalopram Hydrobromide	Tablet equivalent to 10 mg citalopram	Oral	28	5	AF
	Tablet equivalent to 20 mg citalopram	Oral	28	5	AF, AW, CH, GM, GX, LU, RE, SZ, TW
	Tablet equivalent to 40 mg citalopram	Oral	28	5	AF, GX, SZ
Cladribine	Injection 10 mg in 5 mL vial	Injection	7	..	OA
	Solution for I.V. infusion 10 mg in 10 mL single use vial	Injection	7	..	JC
Clarithromycin	Tablet 250 mg	Oral	14	1	AB, AF, AW, CH, GM, GX, HX, TW
Clindamycin Hydrochloride	Capsule equivalent to 150 mg clindamycin	Oral	25	..	KR, PH
Clomiphene Citrate	Tablet 50 mg	Oral	10	5	AV, AW, GX, HX, SG
Clomipramine Hydrochloride	Tablet 25 mg	Oral	50	2	AF, CH, GX, NV, TW
Clonazepam	Tablet 500 micrograms	Oral	200	2	AF, RO
	Tablet 2 mg	Oral	200	2	AF, RO
	Oral liquid 2.5 mg per mL, 10 mL	Oral	2	..	RO
	Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent)	Injection	5	..	RO
Clonidine Hydrochloride	Tablet 100 micrograms	Oral	100	5	BY
	Tablet 150 micrograms	Oral	100	5	BY
Clopidogrel Hydrogen Sulfate	Tablet equivalent to 75 mg clopidogrel	Oral	28	5	BQ, SW
Clotrimazole	Lotion 10 mg per mL, 20 mL	Application	2	3	BN
Coal Tar - Prepared	Gel 10 mg per g, 100 mL	Application	1	2	EP
Codeine Phosphate	Tablet 30 mg	Oral	20	..	FM
Codeine Phosphate with Paracetamol	Tablet 30 mg-500 mg	Oral	20	..	AL, CO, DK, FM, GK, SW
Colchicine	Tablet 500 micrograms	Oral	100	2	AS, LN
Colestipol Hydrochloride	Oral powder, sachets 5 g, 120	Oral	1	5	PH
Copper Sulfate	Tablets, diagnostic compound, 36		2	3	BN
Cortisone Acetate	Tablet 5 mg	Oral	50	4	AS
	Tablet 25 mg	Oral	60	4	AS
Cyclophosphamide	Tablet 50 mg	Oral	50	2	PH
Cyclophosphamide with any determined brand of Sodium Chloride Injection	Powder for injection 500 mg (anhydrous) (with required solvent)	Injection	2	..	BX
	Powder for injection 1 g (anhydrous) (with required solvent)	Injection	1	..	BX
	Powder for injection 2 g (anhydrous) (with required solvent)	Injection	1	..	BX
Cyclosporin	Capsule 10 mg	Oral	120	3	NV
	Capsule 25 mg	Oral	60	3	HX, NV
	Capsule 50 mg	Oral	60	3	HX, NV
	Capsule 100 mg	Oral	60	3	HX, NV
	Oral liquid 100 mg per mL, 50 mL	Oral	2	3	NV
Cyproheptadine Hydrochloride	Tablet 4 mg (anhydrous)	Oral	100	2	FR
Cyproterone Acetate	Tablet 50 mg	Oral	20	5	AF, GM, GX, HX, SC, SY
	Tablet 100 mg	Oral	50	5	GM, GX, HX, SC, SY
Cytarabine	Injection 100 mg in 5 mL vial	Injection	10	1	PU
Dalteparin Sodium	Injection 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe	Injection	10	1	PH
	Injection 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe	Injection	10	1	PH
	Injection 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe	Injection	10	1	PH
	Injection 10,000 I.U. (anti-Xa) in 1 mL single dose pre-filled syringe	Injection	10	1	PH
Danazol	Capsule 100 mg	Oral	100	5	AF
	Capsule 200 mg	Oral	100	5	AF
Dantrolene Sodium	Capsule 25 mg	Oral	100	2	PU
	Capsule 50 mg	Oral	100	2	PU
Dapsone	Tablet 25 mg	Oral	100	1	LM
	Tablet 100 mg	Oral	100	1	LM
Desmopressin Acetate	Intranasal solution 100 micrograms per mL, 2.5 mL dropper bottle	Nasal	5	5	FP
	Tablet 200 micrograms	Oral	30	5	FP
	Nasal spray (pump pack) 10 micrograms per actuation, 60 actuations, 6 mL	Nasal	1	5	FP
Dexamethasone	Tablet 500 micrograms	Oral	30	4	AS
	Tablet 4 mg	Oral	30	4	AS
	Eye drops 1 mg per mL, 5 mL	Application to the eye	1	2	AQ
Dexamethasone Sodium Metasulfobenzoate with Framycetin Sulfate and Gramicidin	Ear drops 500 micrograms (dexamethasone)-5 mg-50 micrograms per mL, 8 mL	Application to the ear	1	2	AV, QM
Dexamethasone Sodium Phosphate	Injection equivalent to 4 mg dexamethasone phosphate in 1 mL ampoule	Injection	5	..	MX
	Injection equivalent to 8 mg dexamethasone phosphate in 2 mL vial	Injection	5	1	MX
	Injection equivalent to 120 mg dexamethasone phosphate in 5 mL vial	Injection	1	..	MX
Dexamphetamine Sulfate	Tablet 5 mg	Oral	100	5	SI
"Dialamine"	Oral powder 200 g	Oral	10	5	SB
Diazepam	Tablet 2 mg	Oral	50	..	AF, AW, RO, SU
	Tablet 5 mg	Oral	50	..	AF, AW, GM, RO, SU
	Injection 10 mg in 2 mL ampoule	Injection	5	..	MX
Diclofenac Sodium	Tablet 25 mg (enteric coated)	Oral	100	3	AF, AW, BG, CH, GM, GX, HX, NV, TW
	Tablet 50 mg (enteric coated)	Oral	50	3	AF, AW, CH, GM, GX, HX, NV, TW
	Suppository 100 mg	Rectal	40	3	NV
Dicloxacillin Sodium	Capsule equivalent to 250 mg dicloxacillin	Oral	24	..	AF, BQ, SI
	Capsule equivalent to 500 mg dicloxacillin	Oral	24	..	AF, BQ, SI
	Powder for injection equivalent to 500 mg dicloxacillin	Injection	5	..	BQ
	Powder for injection equivalent to 1 g dicloxacillin	Injection	5	1	BQ
"Digestelact"	Oral powder 900 g	Oral	3	1	SJ
Digoxin	Tablet 62.5 micrograms	Oral	200	1	FM, SI
	Tablet 250 micrograms	Oral	100	1	FM, SI
	Paediatric oral solution 50 micrograms per mL, 60 mL	Oral	2	3	SI
Dihydroergotamine Mesylate	Injection 1 mg in 1 mL ampoule	Injection	5	..	NV
Diltiazem Hydrochloride	Tablet 60 mg	Oral	90	5	AF, AV, CH, GM, GX, HP, HX, TW
	Capsule 180 mg (controlled delivery)	Oral	30	5	AV, CH, GM, GX, HP, TW
	Capsule 240 mg (controlled delivery)	Oral	30	5	AV, CH, GM, GX, HP, TW
	Capsule 360 mg (controlled delivery)	Oral	30	5	AV, HP
Diphenoxylate Hydrochloride with Atropine Sulfate	Tablet 2.5 mg-25 micrograms	Oral	20	..	KR, PH
Diphtheria and Tetanus Vaccine - Adsorbed	Injection 0.5 mL ampoule	Injection	3	..	CS
Diphtheria and Tetanus Vaccine - Adsorbed (Diluted)	Injection 0.5 mL in pre-filled syringe. For immunisation of adults and children over the age of 8 years	Injection	3	..	CS
Dipivefrine Hydrochloride	Eye drops 1 mg per mL, 10 mL	Application to the eye	1	5	AG
Dipyridamole	Capsule 200 mg (sustained release)	Oral	60	5	BY
Dipyridamole with Aspirin	Capsule 200 mg (sustained release)-25 mg	Oral	60	5	BY
Disodium Etidronate	Tablet 200 mg	Oral	60	5	PU
Disodium Etidronate and Calcium Carbonate	Pack containing 28 tablets disodium etidronate 200 mg and 76 tablets calcium carbonate 1.25 g (equivalent to 500 mg calcium)	Oral	1	1	PU
Disodium Pamidronate	Concentrated injection 15 mg in 5 mL vial	Injection	4	..	MX
	Injection set containing 4 vials powder for I.V. infusion 15 mg and 4 ampoules solvent 5 mL	Injection	1	..	NV
	Concentrated injection 30 mg in 10 mL vial	Injection	2	..	MX
	Injection set containing 2 vials powder for I.V. infusion 30 mg and 2 ampoules solvent 10 mL	Injection	1	..	NV
	Concentrated injection 60 mg in 10 mL vial	Injection	1	..	MX
Disopyramide	Capsule 100 mg	Oral	100	5	AV
	Capsule 150 mg	Oral	100	5	AV
Docetaxel	Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL and 1 single use vial solvent 1.5 mL	Injection	2	..	AV
	Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL and 1 single use vial solvent 6 mL	Injection	1	..	AV
Docusate Sodium with Bisacodyl	Suppositories 100 mg-10 mg, 5	Rectal	6	5	FM
Dolasetron Mesylate	Tablet 200 mg	Oral	2	..	AV
	I.V. injection 100 mg in 5 mL ampoule	Injection	1	..	AV
Domperidone	Tablet 10 mg	Oral	25	..	JC
Donepezil Hydrochloride	Tablet 5 mg	Oral	28	5	PF
	Tablet 10 mg	Oral	28	5	PF
Dorzolamide Hydrochloride	Eye drops equivalent to 20 mg dorzolamide per mL, 5 mL	Application to the eye	1	5	MK
Dorzolamide Hydrochloride with Timolol Maleate	Eye drops equivalent to 20 mg dorzolamide-5 mg timolol per mL, 5 mL	Application to the eye	1	5	MK
Dothiepin Hydrochloride	Capsule 25 mg	Oral	50	2	AB, AF
	Tablet 75 mg	Oral	30	2	AB, AF
Doxepin Hydrochloride	Tablet equivalent to 50 mg doxepin	Oral	50	2	AF
	Capsule equivalent to 10 mg doxepin	Oral	50	2	AF, PF
	Capsule equivalent to 25 mg doxepin	Oral	50	2	AF, PF
Doxorubicin Hydrochloride	Solution for I.V. injection or intravesical administration 10 mg in 5 mL single dose vial	Injection or intravesical administration	4	..	IT, MX, PH
	Solution for I.V. injection or intravesical administration 20 mg in 10 mL single dose vial	Injection or intravesical administration	4	..	PH
	Solution for I.V. injection or intravesical administration 50 mg in 25 mL single dose vial	Injection or intravesical administration	3	..	IT, MX, PH
	Solution for I.V. injection or intravesical administration 100 mg in 50 mL single dose vial	Injection or intravesical administration	1	..	IT
	Solution for I.V. injection or intravesical administration 200 mg in 100 mL single dose vial	Injection or intravesical administration	1	..	IT
Doxorubicin Hydrochloride - Pegylated Liposomal	Suspension for I.V. infusion 20 mg in 10 mL vial	Injection	1	..	SH
	Suspension for I.V. infusion 50 mg in 25 mL vial	Injection	1	..	SH
Doxycycline Hydrochloride	Tablet equivalent to 50 mg doxycycline	Oral	25	5	AF, GM, PF
	Capsule equivalent to 50 mg doxycycline (containing enteric coated pellets)	Oral	25	5	FA, MX
	Tablet equivalent to 100 mg doxycycline	Oral	7	1	AF, GM, PF, SI
	Capsule equivalent to 100 mg doxycycline (containing enteric coated pellets)	Oral	7	1	FA, MX
Doxycycline Monohydrate	Tablet equivalent to 50 mg doxycycline	Oral	25	5	AW, CH, GX, SZ, TW
	Tablet equivalent to 100 mg doxycycline	Oral	7	1	CH, GX, SZ, TW
Drotrecogin Alfa (Activated)	Powder for I.V. infusion 5 mg, vial	Injection	1	..	LY
	Powder for I.V. infusion 20 mg, vial	Injection	1	..	LY
"Duocal"	Oral powder 400 g	Oral	8	5	SB
Dydrogesterone	Tablet 10 mg	Oral	28	2	SM
"Easiphen"	Oral liquid 250 mL	Oral	90	5	SB
Efalizumab	Injection set containing 4 vials powder for injection 125 mg and 4 pre-filled syringes diluent 1.3 mL	Injection	1	3	SG
Eformoterol Fumarate Dihydrate	Capsule containing powder for oral inhalation 12 micrograms (for use in Foradile Aerolizer)	Inhalation by mouth	60	5	NV
	Powder for oral inhalation in breath actuated device 6 micrograms per dose, 60 doses	Inhalation by mouth	1	5	AP
	Powder for oral inhalation in breath actuated device 12 micrograms per dose, 60 doses	Inhalation by mouth	1	5	AP
"EleCare"	Oral powder 400 g	Oral	8	5	AB
Enalapril Maleate	Tablet 5 mg	Oral	30	5	AF, BF, CH, GM, GX, HX, MK, SI, TW
	Tablet 10 mg	Oral	30	5	AF, BF, CH, FR, GM, GX, HX, MK, SI, TW
	Tablet 20 mg	Oral	30	5	AF, BF, CH, FR, GM, GX, HX, MK, SI, TW
Enalapril Maleate with Hydrochlorothiazide	Tablet 20 mg-6 mg	Oral	30	5	MK
"Energivit"	Oral powder 400 g	Oral	8	5	SB
Enoxaparin Sodium	Injection 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe	Injection	10	1	AV
	Injection 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe	Injection	10	1	AV
	Injection 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe	Injection	10	1	AV
	Injection 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe	Injection	10	1	AV
	Injection 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe	Injection	10	1	AV
Entacapone	Tablet 200 mg	Oral	200	4	NV
Epirubicin Hydrochloride	Solution for injection 10 mg in 5 mL	Injection or intravesical administration	4	..	IT, PH
	Solution for injection 20 mg in 10 mL	Injection or intravesical administration	4	..	PH
	Solution for injection 50 mg in 25 mL	Injection or intravesical administration	3	..	IT, PH
	Powder for injection 50 mg	Injection or intravesical administration	3	..	MX
	Solution for injection 100 mg in 50 mL	Injection or intravesical administration	2	..	IT
	Solution for injection 200 mg in 100 mL	Injection or intravesical administration	1	..	IT
Eplerenone	Tablet 25 mg	Oral	30	5	PF
	Tablet 50 mg	Oral	30	5	PF
Eprosartan Mesylate	Tablet equivalent to 400 mg eprosartan	Oral	56	5	SM
	Tablet equivalent to 600 mg eprosartan	Oral	28	5	SM
Eprosartan Mesylate with Hydrochlorothiazide	Tablet equivalent to 600 mg eprosartan with 12.5 mg hydrochlorothiazide	Oral	28	5	SM
Eptifibatide Acetate	Solution for I.V. injection equivalent to 20 mg eptifibatide in 10 mL vial	Injection	2	..	SH
	Solution for I.V. infusion equivalent to 75 mg eptifibatide in 100 mL vial	Injection	3	..	SH
Erythromycin	Capsule 250 mg (containing enteric coated pellets)	Oral	25	1	FA, MX
Erythromycin Ethyl Succinate	Tablet equivalent to 400 mg erythromycin	Oral	25	1	AB, AF
Erythromycin Ethyl Succinate with Water - Purified BP	Powder for oral liquid equivalent to 200 mg erythromycin per 5 mL, 100 mL	Oral	1	1	AB, AF
	Powder for oral liquid equivalent to 400 mg erythromycin per 5 mL, 100 mL	Oral	1	1	AB, AF
Erythromycin Lactobionate	Powder for I.V. infusion equivalent to 1 g erythromycin, vial	Injection	5	..	AB
Escitalopram Oxalate	Tablet equivalent to 10 mg escitalopram	Oral	28	5	CF, LU
	Tablet equivalent to 20 mg escitalopram	Oral	28	5	CF, LU
	Oral solution equivalent to 10 mg escitalopram per mL, 28 mL	Oral	1	5	LU
Esomeprazole Magnesium Trihydrate	Tablet (enteric coated), equivalent to 20 mg esomeprazole	Oral	30	1	AP
	Tablet (enteric coated), equivalent to 40 mg esomeprazole	Oral	30	1	AP
Esomeprazole Magnesium Trihydrate and Clarithromycin and Amoxycillin Trihydrate	Pack containing 14 tablets (enteric coated) esomeprazole magnesium trihydrate equivalent to 20 mg esomeprazole, 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin trihydrate equivalent to 500 mg amoxycillin	Oral	1	..	AP
Etanercept	Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL	Injection	2	2	WY
	Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL	Injection	1	2	WY
Ethacrynic Acid	Tablet 25 mg	Oral	200	1	MK
Ethosuximide	Capsule 250 mg	Oral	200	2	PF
	Oral solution 250 mg per 5 mL, 200 mL	Oral	1	5	PF
Etonogestrel	Subcutaneous implant 68 mg	Subcutaneous implantation	1	..	OR
Etoposide	Capsule 50 mg	Oral	20	..	BQ
	Capsule 100 mg	Oral	10	..	BQ
	Solution for I.V. infusion 100 mg in 5 mL vial	Injection	5	..	IT, MX
Etoposide Phosphate	Powder for I.V. infusion 113.6 mg, vial	Injection	5	..	BQ
	Powder for I.V. infusion 1.136 g, vial	Injection	1	..	BQ
Everolimus	Tablet 0.25 mg	Oral	60	3	NV
	Tablet 0.5 mg	Oral	60	3	NV
	Tablet 0.75 mg	Oral	120	3	NV
Exemestane	Tablet 25 mg	Oral	30	5	PH
Ezetimibe	Tablet 10 mg	Oral	30	5	MK
Ezetimibe with Simvastatin	Tablet 10 mg-40 mg	Oral	30	5	MK
	Tablet 10 mg-80 mg	Oral	30	5	MK
Famciclovir	Tablet 125 mg	Oral	40	1	NV
	Tablet 250 mg	Oral	21	..	NV
	Tablet 500 mg	Oral	30	..	NV
Famotidine	Tablet 20 mg	Oral	60	5	AF, AW, CH, GM, GX, HX, MK, TW
	Tablet 40 mg	Oral	30	5	AF, AW, CH, GM, GX, HX, MK, TW
Felodipine	Tablet 2.5 mg (extended release)	Oral	30	5	AL, AP
	Tablet 5 mg (extended release)	Oral	30	5	AL, AP
	Tablet 10 mg (extended release)	Oral	30	5	AL, AP
Fenofibrate	Tablet 48 mg	Oral	60	5	LF
	Tablet 145 mg	Oral	30	5	LF
Fentanyl	Transdermal patch 2.1 mg	Transdermal	5	..	JC
	Transdermal patch 4.2 mg	Transdermal	5	..	JC
	Transdermal patch 8.4 mg	Transdermal	5	..	JC
	Transdermal patch 12.6 mg	Transdermal	5	..	JC
	Transdermal patch 16.8 mg	Transdermal	5	..	JC
Ferrous Fumarate with Folic Acid	Tablet 310 mg (equivalent to 100 mg iron)-350 micrograms	Oral	60	1	AE
Ferrous Sulfate	Oral liquid 30 mg per mL, 250 mL	Oral	1	2	AE
Flecainide Acetate	Tablet 50 mg	Oral	60	5	MM
	Tablet 100 mg	Oral	60	5	AF, MM
Flucloxacillin Magnesium with Water - Purified BP	Powder for oral suspension equivalent to 125 mg flucloxacillin per 5 mL, 100 mL	Oral	1	..	GK
	Powder for oral suspension equivalent to 250 mg flucloxacillin per 5 mL, 100 mL	Oral	1	..	CS, GK
Flucloxacillin Sodium	Capsule equivalent to 250 mg flucloxacillin	Oral	24	..	AF, CS, GK, SI
	Capsule equivalent to 500 mg flucloxacillin	Oral	24	..	AF, CS, GK, SI
	Powder for injection equivalent to 500 mg flucloxacillin	Injection	5	..	CS, GM
	Powder for injection equivalent to 1 g flucloxacillin	Injection	5	1	AS, CS, GM, MX
Fluconazole	Capsule 50 mg	Oral	28	5	AF, AW, HX, MX, PF, RA
	Capsule 100 mg	Oral	28	5	AF, HX, MX, PF, RA
	Capsule 200 mg	Oral	28	5	AF, AW, HX, MX, PF, RA
	Solution for I.V. infusion 100 mg in 50 mL vial	Injection	7	..	PF
	Solution for I.V. infusion 200 mg in 100 mL vial	Injection	7	..	PF
Fludrocortisone Acetate	Tablet 100 micrograms	Oral	200	1	BQ
Fluorometholone	Eye drops 1 mg per mL, 5 mL	Application to the eye	1	5	AG, AQ
Fluorometholone Acetate	Eye drops 1 mg per mL, 5 mL	Application to the eye	1	2	AQ
Fluorouracil	Injection 500 mg in 10 mL	Injection	10	..	IT, MX
	Injection 1000 mg in 20 mL	Injection	5	..	IT
Fluoxetine Hydrochloride	Tablet, dispersible, equivalent to 20 mg fluoxetine	Oral	28	5	AL, LY
	Capsule equivalent to 20 mg fluoxetine	Oral	28	5	AF, AL, BF, CH, GM, GX, HX, LY, SI, TW
Flupenthixol Decanoate	Oily I.M. injection 20 mg in 1 mL ampoule	Injection	5	..	LU
	Oily I.M. injection 40 mg in 2 mL ampoule	Injection	5	..	LU
	Oily I.M. injection 100 mg in 1 mL ampoule	Injection	5	..	LU
Fluphenazine Decanoate	Injection 12.5 mg in 0.5 mL ampoule	Injection	5	..	BQ
	Injection 25 mg in 1 mL ampoule	Injection	5	..	BQ
	Injection 50 mg in 2 mL ampoule	Injection	5	..	BQ
Flurbiprofen Sodium	Eye drops 300 micrograms per mL, single dose units 0.4 mL, 5	Application to the eye	1	..	AG
Flutamide	Tablet 250 mg	Oral	100	5	AF, SH
Fluticasone Propionate	Pressurised inhalation 50 micrograms per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	1	5	GK
	Pressurised inhalation 125 micrograms per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	1	5	GK
	Pressurised inhalation 250 micrograms per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	1	1	GK
	Powder for oral inhalation in breath actuated device 100 micrograms per dose, 60 doses	Inhalation by mouth	1	5	GK
	Powder for oral inhalation in breath actuated device 250 micrograms per dose, 60 doses	Inhalation by mouth	1	5	GK
	Powder for oral inhalation in breath actuated device 500 micrograms per dose, 60 doses	Inhalation by mouth	1	1	GK
Fluticasone Propionate with Salmeterol Xinafoate	Pressurised inhalation 50 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 25 micrograms salmeterol per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	1	5	GK
	Pressurised inhalation 125 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 25 micrograms salmeterol per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	1	5	GK
	Pressurised inhalation 250 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 25 micrograms salmeterol per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	1	5	GK
	Powder for oral inhalation in breath actuated device 100 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 50 micrograms salmeterol per dose, 60 doses	Inhalation by mouth	1	5	GK
	Powder for oral inhalation in breath actuated device 250 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 50 micrograms salmeterol per dose, 60 doses	Inhalation by mouth	1	5	GK
	Powder for oral inhalation in breath actuated device 500 micrograms fluticasone propionate with salmeterol xinafoate equivalent to 50 micrograms salmeterol per dose, 60 doses	Inhalation by mouth	1	5	GK
Fluvastatin Sodium	Capsule equivalent to 20 mg fluvastatin	Oral	28	5	NM, NV
	Capsule equivalent to 40 mg fluvastatin	Oral	28	5	NM, NV
Fluvoxamine Maleate	Tablet 50 mg	Oral	30	5	AL, AW, HX, SM
	Tablet 100 mg	Oral	30	5	AF, AW, HX, SM
Folic Acid	Tablet 500 micrograms	Oral	200	..	AF
	Tablet 5 mg	Oral	200	1	AF
Follitropin Alfa	Injection set containing 1 vial powder for injection 75 I.U. and 1 pre-filled syringe solvent 1 mL	Injection	5	5	SG
	Injection set containing 10 vials powder for injection 75 I.U. and 10 pre-filled syringes solvent 1 mL	Injection	1	5	SG
	Injection 300 I.U. in 0.5 mL multi-dose cartridge	Injection	3	5	SG
	Injection set containing 1 vial powder for injection 450 I.U. and 1 pre-filled syringe solvent 1 mL	Injection	3	5	SG
	Injection 450 I.U. in 0.75 mL multi-dose cartridge	Injection	3	5	SG
	Injection 900 I.U. in 1.5 mL multi-dose cartridge	Injection	2	5	SG
	Injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre-filled syringe solvent 2 mL	Injection	1	5	SG
Follitropin Beta	Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge	Injection	3	5	OR
	Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge	Injection	2	5	OR
	Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge	Injection	2	5	OR
Fondaparinux Sodium	Injection 2.5 mg in 0.5 mL single dose pre-filled syringe	Injection	7	..	GK
Fosinopril Sodium	Tablet 10 mg	Oral	30	5	AF, AW, BQ, GX
	Tablet 20 mg	Oral	30	5	AF, AW, BQ, GX
Fosinopril Sodium with Hydrochlorothiazide	Tablet 10 mg-12.5 mg Tablet 20 mg-12.5 mg	Oral Oral	30 30	5 5	BQ BQ
Fotemustine	Powder for injection 208 mg with solvent	Injection	1	4	SE
Framycetin Sulfate	Eye or ear drops 5 mg per mL, 8 mL	Application to the eye or ear	1	2	AV
Frusemide	Tablet 20 mg	Oral	100	1	AV, CH, FM, GM, GX, TW
	Tablet 40 mg	Oral	100	1	AF, AV, CH, FM, GM, GX, HX, TW
	Tablet 500 mg	Oral	50	3	FM
	Oral solution 10 mg per mL, 30 mL	Oral	1	3	AV
	Injection 20 mg in 2 mL	Injection	5	..	AV, HX
Gabapentin	Capsule 100 mg	Oral	100	5	AF, AW, MX, PF
	Capsule 300 mg	Oral	100	5	AF, AL, AW, GM, GX, HX, MX, PF
	Capsule 400 mg	Oral	100	5	AF, AL, AW, GM, GX, HX, MX, PF
	Tablet 600 mg	Oral	100	5	PF
	Tablet 800 mg	Oral	100	5	AF, AW, PF
Galantamine Hydrobromide	Capsule (prolonged release) equivalent to 8 mg galantamine	Oral	28	5	JC
	Capsule (prolonged release) equivalent to 16 mg galantamine	Oral	28	5	JC
	Capsule (prolonged release) equivalent to 24 mg galantamine	Oral	28	5	JC
Gefitinib	Tablet 250 mg	Oral	30	1	AP
Gelatin - Succinylated	I.V. infusion 20 g per 500 mL, 500 mL	Injection	3	..	BR
Gemcitabine Hydrochloride	Powder for I.V. infusion equivalent to 200 mg gemcitabine	Injection	4	2	LY
	Powder for I.V. infusion equivalent to 1 g gemcitabine	Injection	2	2	LY
Gemfibrozil	Tablet 600 mg	Oral	60	5	AF, CH, GM, GX, HX, PF, SI, TW
Gentamicin Sulfate	Injection equivalent to 80 mg gentamicin in 2 mL ampoule	Injection	10	1	MX, PU
	Eye drops equivalent to 3 mg gentamicin per mL, 5 mL	Application to the eye	1	2	AG
Gestrinone	Capsule 2.5 mg	Oral	8	5	AV
Glatiramer Acetate	Injection 20 mg in 1 mL single dose pre-filled syringe	Injection	28	5	AV
Glibenclamide	Tablet 5 mg	Oral	100	5	AF, AV
Gliclazide	Tablet 30 mg (modified release)	Oral	100	5	SE
	Tablet 80 mg	Oral	100	5	AF, AW, CH, GX, HX, SE, TW
Glimepiride	Tablet 1 mg	Oral	30	5	AF, AV, AW, ML, SZ
	Tablet 2 mg	Oral	30	5	AF, AV, AW, ML, SZ
	Tablet 3 mg	Oral	30	5	AF, AV, AW, ML, SZ
	Tablet 4 mg	Oral	30	5	AF, AV, AW, ML, SZ
Glipizide	Tablet 5 mg	Oral	100	5	AF, PH
Glucagon Hydrochloride	Injection set containing 1 mg (1 I.U.) and 1 mL solvent in disposable syringe	Injection	1	1	NO
Glucose	I.V. infusion 278 mmol (anhydrous) per L, 1 L	Injection	5	1	BX
Glucose and Ketone Indicator—Urine	Reagent strips, 50 (Keto-Diabur-Test 5000)		2	2	RD
	Reagent strips, 50 (Keto-Diastix)		2	2	BN
Glucose with Sodium Chloride, Potassium Chloride and Sodium Acid Citrate	Oral rehydration salts 3.56 g-470 mg-300 mg-530 mg per sachet, 10	Oral	1	..	AS, AV, CH, GM, TW
Glucose Indicator—Blood	Electrode strips, 50 (Advantage II)		2	5	RD
	Electrode strips, 50 (Ascensia Elite)		2	5	BN
	Electrode strips, 50 (Freestyle Papillon)		2	5	MS
	Electrode strips, 50 (Glucocard 01 Sensor)		2	5	DR
	Electrode strips, 50 (GlucoCare)		2	5	DR
	Electrode strips, 50 (GlucoCare Super Sensor)		2	5	DR
	Electrode strips, 50 (GlucoMen Sensor)		2	5	GD
	Electrode strips, 50 (MWD Pen Sensor Strips)		2	5	WF
	Electrode strips, 50 (Omnitest EZ)		2	5	BR
	Electrode strips, 50 (Omnitest Plus)		2	5	BR
	Electrode strips, 50 (Touch-In Plus)		2	5	DN
	Electrode strips, 50 (TrueTrack)		2	5	DR
	Discs containing electrode sensors, 10 sensors per disc, 5		2	5	BN
	Electrode strips, 100 (Optium glucose)		1	5	MS
	Electrode strips, 100 (Precision Plus)		1	5	MS
	Electrode strips, 100 (SofTact)		1	5	MS
	Electrode strips, 100 (TrueSense)		1	5	MS
	Reagent strips, 50 (Accu-Chek Active)		2	5	RD
	Reagent strips, 50 (Accu-Chek Go)		2	5	RD
	Reagent strips, 51 (Accu-Chek Integra)		2	5	RD
	Reagent strips, 50 (Betachek)		2	5	NA
	Reagent strips, 50 (CareSens)		2	5	LB
	Reagent strips, 50 (Glucoflex-R)		2	5	NA
	Reagent strips, 50 (Glucostix)		2	5	BN
	Reagent strips, 50 (SensoCard)		2	5	PX
Glucose Indicator—Urine	Reagent strips, 50 (Clinistix)		2	2	BN
	Reagent strips, 50 (Diastix)		2	2	BN
Glycerol	Suppositories 700 mg, 12	Rectal	3	5	PP
	Suppositories 1.4 g, 12	Rectal	3	5	PP
	Suppositories 2.8 g, 12	Rectal	3	5	PP
Glyceryl Trinitrate	Tablets 600 micrograms, 100	Oral	1	5	FM, SI
	Buccal/sublingual spray (pump pack) 400 micrograms per dose, 200 doses	Buccal/ sublingual	1	5	AV
	Transdermal patch 18 mg	Transdermal	30	5	MM
	Transdermal patch 25 mg	Transdermal	30	5	NV
	Transdermal patch 40 mg	Transdermal	30	5	SH
	Transdermal patch 36 mg	Transdermal	30	5	MM
	Transdermal patch 50 mg	Transdermal	30	5	NV
	Transdermal patch 80 mg	Transdermal	30	5	SH
	Transdermal patch 54 mg	Transdermal	30	5	MM
	Transdermal patch 120 mg	Transdermal	30	5	SH
Goserelin Acetate	Subcutaneous implant equivalent to 3.6 mg goserelin in pre-filled injection syringe	Subcutaneous implantation	1	5	AP
	Subcutaneous implant (long acting) equivalent to 10.8 mg goserelin in pre-filled injection syringe	Subcutaneous implantation	1	1	AP
Granisetron Hydrochloride	Tablet equivalent to 2 mg granisetron	Oral	2	..	MX
	Concentrated injection equivalent to 3 mg granisetron in 3 mL ampoule	Injection	1	..	MX
Griseofulvin	Tablet 125 mg	Oral	100	2	SI
	Tablet 500 mg	Oral	28	2	SI
Haloperidol	Tablet 500 micrograms	Oral	100	5	SI
	Tablet 1.5 mg	Oral	100	5	SI
	Tablet 5 mg	Oral	50	5	SI
	Oral solution 2 mg per mL, 100 mL	Oral	1	5	SI
	Injection 5 mg in 1 mL ampoule	Injection	10	..	SI
Haloperidol Decanoate	I.M. injection equivalent to 50 mg haloperidol in 1 mL ampoule	Injection	5	..	JC
	I.M. injection equivalent to 150 mg haloperidol in 3 mL ampoule	Injection	5	..	JC
"HCU express"	Sachets containing oral powder 25 g, 30	Oral	4	5	VF
"HCU gel"	Sachets containing oral powder 20 g, 30	Oral	4	5	VF
Heparin Sodium	Injection 5,000 units in 0.2 mL ampoule	Injection	5	5	MX
	Injection (preservative-free) 5,000 I.U. in 5 mL ampoule	Injection	50	5	PU
	Injection 35,000 units in 35 mL vial	Injection	12	5	MX
Hexamine Hippurate	Tablet 1 g	Oral	100	5	MM
Homatropine Hydrobromide	Eye drops 20 mg per mL, 15 mL	Application to the eye	1	2	AQ
Hydralazine Hydrochloride	Tablet 25 mg	Oral	200	2	AF
	Tablet 50 mg	Oral	200	2	AF
Hydrochlorothiazide	Tablet 25 mg	Oral	100	1	PL
Hydrochlorothiazide with Amiloride Hydrochloride	Tablet 50 mg-5 mg	Oral	100	1	AF, MK
Hydrochlorothiazide with Triamterene	Tablet 25 mg-50 mg	Oral	100	1	AF
Hydrocortisone	Tablet 4 mg	Oral	50	4	AF
	Tablet 20 mg	Oral	60	4	AF
	Cream 10 mg per g, 50 g	Application	1	1	EO
Hydrocortisone Acetate	Eye ointment 5 mg per g, 5 g	Application to the eye	1	..	SI
	Eye ointment 10 mg per g, 5 g	Application to the eye	1	..	SI
	Cream 10 mg per g, 30 g	Application	1	1	FM, SI
	Cream 10 mg per g, 50 g	Application	1	1	DT, FM, SI
	Ointment 10 mg per g, 30 g	Application	1	1	FM, SI
	Ointment 10 mg per g, 50 g	Application	1	1	FM, SI
	Rectal foam 90 mg per applicatorful, 14 applications, aerosol 21.1 g	Rectal	2	3	GC
Hydrocortisone Sodium Succinate	Injection equivalent to 100 mg hydrocortisone with 2 mL solvent	Injection	2	..	PH
	Injection equivalent to 250 mg hydrocortisone with 2 mL solvent	Injection	1	..	PH
Hydromorphone Hydrochloride	Tablet 2 mg	Oral	20	..	AB
	Tablet 4 mg	Oral	20	..	AB
	Tablet 8 mg	Oral	20	..	AB
	Oral liquid 1 mg per mL, 473 mL	Oral	1	..	AB
	Injection 2 mg in 1 mL ampoule	Injection	5	..	AB
	Injection 10 mg in 1 mL ampoule	Injection	5	..	AB
	Injection 50 mg in 5 mL ampoule	Injection	5	..	AB
	Injection 500 mg in 50 mL vial	Injection	1	..	AB
Hydroxocobalamin	Injection 1 mg in 1 mL ampoule	Injection	2	..	MX
	Injection 1 mg in 1 mL	Injection	3	..	MX
Hydroxychloroquine Sulfate	Tablet 200 mg	Oral	100	1	SW
Hydroxyurea	Capsule 500 mg	Oral	100	..	BQ
Hypromellose	Eye drops 3 mg per mL, 15 mL	Application to the eye	1	5	NM, NV
	Eye drops 5 mg per mL, 15 mL	Application to the eye	1	5	AQ, SI
Hypromellose with Carbomer 980	Ocular lubricating gel 3 mg-2 mg per g, 10 g	Application to the eye	1	5	NM, NV
Hypromellose 2900 with Dextran 70	Eye drops 3 mg-1 mg per mL, single dose units 0.4 mL, 28	Application to the eye	3	5	AQ
Hypromellose 4500 with Dextran 70	Eye drops 3 mg-1 mg per mL, 15 mL	Application to the eye	1	5	AQ, IQ
Ibuprofen	Tablet 200 mg	Oral	100	3	AF
	Tablet 400 mg	Oral	30	..	AB
Idarubicin Hydrochloride	Capsule 5 mg	Oral	3	..	PH
	Capsule 10 mg	Oral	3	..	PH
	Solution for I.V. injection 5 mg in 5 mL single use vial	Injection	3	..	PH
	Solution for I.V. injection 10 mg in 10 mL single use vial	Injection	6	..	PH
Ifosfamide	Powder for I.V. injection 1 g in single dose vial	Injection	5	5	BX
	Powder for I.V. injection 2 g in single dose vial	Injection	5	5	BX
Imipramine Hydrochloride	Tablet 10 mg	Oral	50	2	LN, NV
	Tablet 25 mg	Oral	50	2	LN, NV
Imiquimod	Cream 50 mg per g, 250 mg single use sachets, 12	Application	1	1	MM
Indapamide Hemihydrate	Tablet 1.5 mg (sustained release)	Oral	90	1	SE
	Tablet 2.5 mg	Oral	90	1	AF, CH, GM, GX, HX, SE, SI, TW
Indomethacin	Capsule 25 mg	Oral	100	3	AF, MK
	Suppository 100 mg	Rectal	40	3	MK
Influenza Vaccine (Split Virion) - Inactivated	Injection containing antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain 15 micrograms haemagglutinin; A/Wisconsin/67/2005 (H3N2)-like strain 15 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe	Injection	1	..	AX, CS, GK, SM
Insect Allergen Extract—Honey Bee Venom	Injection set containing 550 micrograms vial with 9 mL vial solvent and 3 vials diluent 1.8 mL	Injection	1	..	ES
Insect Allergen Extract—Paper Wasp Venom	Injection set containing 550 micrograms vial with 9 mL vial solvent and 3 vials diluent 1.8 mL	Injection	1	..	ES
Insect Allergen Extract—Yellow Jacket Venom	Injection set containing 550 micrograms vial with 9 mL vial solvent and 3 vials diluent 1.8 mL	Injection	1	..	ES
Insulin - Isophane	Injection (bovine) 100 units per mL, 10 mL vial	Injection	5	2	AS
	Injection (human) 100 units per mL, 10 mL vial	Injection	5	2	LY, NO
	Injections (human), cartridges, 100 units per mL, 3 mL, 5	Injection	5	1	LY, NI, NL, NO
Insulin - Neutral	Injection (bovine) 100 units per mL, 10 mL vial	Injection	5	2	AS
	Injection (human) 100 units per mL, 10 mL vial	Injection	5	2	LY, NO
	Injections (human), cartridges, 100 units per mL, 3 mL, 5	Injection	5	1	LY, NO
Insulin - Neutral with Insulin - Isophane	Injection (human) 30 units-70 units per mL, 10 mL vial	Injection	5	2	LY, NO
	Injection (human) 50 units-50 units per mL, 10 mL vial	Injection	5	2	NO
	Injections (human), cartridges, 20 units-80 units per mL, 3 mL, 5	Injection	5	1	NO
	Injections (human), cartridges, 30 units-70 units per mL, 3 mL, 5	Injection	5	1	LY, NI, NO
	Injections (human), cartridges, 50 units-50 units per mL, 3 mL, 5	Injection	5	1	NO
Insulin Aspart	Injection (human analogue) 100 units per mL, 10 mL vial	Injection	5	2	NO
	Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5	Injection	5	1	NF, NO
Insulin Aspart with Insulin Aspart Protamine Suspension	Injections (human analogue), cartridges, 30 units-70 units per mL, 3 mL, 5	Injection	5	1	NF, NO
Insulin Detemir	Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5	Injection	5	1	NF
Insulin Glargine	Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5	Injection	5	1	AV
Insulin Lispro	Injection (human analogue) 100 units per mL, 10 mL vial	Injection	5	2	LY
	Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5	Injection	5	1	LY
Insulin Lispro with Insulin Lispro Protamine Suspension	Injections (human analogue), cartridges, 25 units-75 units per mL, 3 mL, 5	Injection	5	1	LY
	Injections (human analogue), cartridges, 50 units-50 units per mL, 3 mL, 5	Injection	5	1	LY
Interferon Alfa-2a	Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe	Injection	15	4	RO
	Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe	Injection	5	4	RO
	Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe	Injection	5	4	RO
	Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe	Injection	5	4	RO
Interferon Alfa-2b	Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen	Injection	3	4	SH
	Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen	Injection	3	5	SH
Interferon Beta-1a	Injection set comprising 1 vial powder for injection 30 micrograms (6,000,000 I.U.) with diluent	Injection	4	5	BD
	Injection 30 micrograms (6,000,000 I.U.) in 0.5 mL single dose pre-filled syringe	Injection	4	5	BD
	Injection 44 micrograms (12,000,000 I.U.) in 0.5 mL single dose pre-filled syringe	Injection	12	5	SG
Interferon Beta-1b	Injection set comprising 1 vial powder for injection 8,000,000 I.U. (250 micrograms) and solvent	Injection	15	5	SC
Ipratropium Bromide	Pressurised inhalation 21 micrograms per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	2	5	BY
	Nebuliser solution 250 micrograms (anhydrous) in 1 mL single dose units, 30	Inhalation	2	5	AF, AW, BY, CH, GM, GX, PU, TW
	Nebuliser solution 500 micrograms (anhydrous) in 1 mL single dose units, 30	Inhalation	2	5	AF, AW, BY, CH, GM, GX, PU, TW
	Nebuliser solution 250 micrograms (anhydrous) per mL, 20 mL	Inhalation	2	2	BY
Irbesartan	Tablet 75 mg	Oral	30	5	BQ, SW
	Tablet 150 mg	Oral	30	5	BQ, SW
	Tablet 300 mg	Oral	30	5	BQ, SW
Irbesartan with Hydrochlorothiazide	Tablet 150 mg-12.5 mg Tablet 300 mg-12.5 mg	Oral Oral	30 30	5 5	BQ, SW BQ, SW
Irinotecan Hydrochloride Trihydrate	I.V. injection 40 mg in 2 mL vial I.V. injection 100 mg in 5 mL vial	Injection Injection	1 2	3 3	MX, PU MX, PU
Iron Polymaltose Complex	Injection 100 mg (iron) in 2 mL ampoule	Injection	5	..	BX, SI
Iron Sucrose	Concentrate for solution for infusion 2.7 g (equivalent to 100 mg iron (III)) in 5 mL ampoule	Injection	5	..	BX
Isoniazid	Tablet 100 mg	Oral	100	2	FM
Isosorbide Dinitrate	Tablet 10 mg	Oral	200	2	AF, SI
	Tablet 5 mg (sublingual)	Oral	200	2	SI
Isosorbide Mononitrate	Tablet 60 mg (sustained release)	Oral	30	5	AF, AP, CH, GM, GX, HX, PM, TW
	Tablet 120 mg (sustained release)	Oral	30	5	AP, PM
Isotretinoin	Capsule 10 mg	Oral	60	3	GM, GX, RO
	Capsule 20 mg	Oral	60	3	CH, GM, GX, HX, RO, TW
Itraconazole	Capsule 100 mg	Oral	60	5	JC
Ivermectin	Tablet 3 mg	Oral	4	..	MK
"Karicare De-Lact"	Oral powder 900 g	Oral	5	..	NU
Ketoconazole	Tablet 200 mg	Oral	10	..	JC
	Cream 20 mg per g, 30 g	Application	1	2	JC
	Shampoo 10 mg per g, 100 mL	Application	1	1	JC
	Shampoo 20 mg per g, 60 mL	Application	1	1	JC
"Ketonex-1"	Oral powder 350 g	Oral	8	5	AB
"Ketonex-2"	Oral powder 325 g	Oral	10	5	AB
Ketoprofen	Capsule 200 mg (sustained release)	Oral	28	3	AV, HP
	Suppository 100 mg	Rectal	40	3	AV
"Kindergen"	Oral powder 400 g	Oral	16	5	SB
Labetalol Hydrochloride	Tablet 100 mg	Oral	100	5	AF, SI
	Tablet 200 mg	Oral	100	5	AF, SI
Lactulose	Solution BP 3.34 g per 5 mL, 500 mL	Oral	1	5	AF, AW, GM, GX, HX, SM
Lamotrigine	Tablet 5 mg	Oral	56	5	AF, AW, GK, HX, ME
	Tablet 25 mg	Oral	56	5	AF, AW, GK, GM, GX, HX, ME, RA
	Tablet 50 mg	Oral	56	5	AF, AW, GK, GM, GX, HX, ME, RA
	Tablet 100 mg	Oral	56	5	AF, AW, GK, GM, GX, HX, ME, RA
	Tablet 200 mg	Oral	56	5	AF, AW, GK, GM, GX, HX, ME, RA
Lansoprazole	Capsule 30 mg	Oral	30	1	WY
	Sachet containing granules for oral suspension, 30 mg per sachet	Oral	28	1	WY
	Capsule 15 mg	Oral	30	5	WY
Latanoprost	Eye drops 50 micrograms per mL, 2.5 mL	Application to the eye	1	5	PU
Latanoprost with Timolol Maleate	Eye drops 50 micrograms latanoprost with timolol maleate equivalent to 5 mg timolol per mL, 2.5 mL	Application to the eye	1	5	PF
Leflunomide	Pack containing 3 tablets leflunomide 100 mg and 30 tablets leflunomide 20 mg	Oral	1	..	AV
	Tablet 10 mg	Oral	30	5	AV, HP
	Tablet 20 mg	Oral	30	5	AV, HP
Lercanidipine Hydrochloride	Tablet 10 mg	Oral	30	5	SM
	Tablet 20 mg	Oral	30	5	SM
Letrozole	Tablet 2.5 mg	Oral	30	5	NV
Leuprorelin Acetate	I.M. injection (modified release), powder for injection 7.5 mg with diluent in pre-filled dual-chamber syringe	Injection	1	5	AB
	Suspension for subcutaneous injection (modified release), 7.5 mg injection set	Injection	1	5	MX
	I.M. injection (modified release), powder for injection 22.5 mg with diluent in pre-filled dual-chamber syringe	Injection	1	1	AB
	Suspension for subcutaneous injection (modified release), 22.5 mg injection set	Injection	1	1	MX
	I.M. injection (modified release), powder for injection 30 mg with diluent in pre-filled dual-chamber syringe	Injection	1	1	AB
	Suspension for subcutaneous injection (modified release), 30 mg injection set	Injection	1	1	MX
	Suspension for subcutaneous injection (modified release), 45 mg injection set	Injection	1	..	MX
Levetiracetam	Tablet 250 mg	Oral	60	5	UC
	Tablet 500 mg	Oral	60	5	UC
	Tablet 1 g	Oral	60	5	UC
Levobunolol Hydrochloride	Eye drops 2.5 mg per mL, 5 mL	Application to the eye	1	5	AG
Levodopa with Benserazide Hydrochloride	Dispersible tablet 50 mg-12.5 mg (benserazide)	Oral	100	5	RO
	Dispersible tablet 100 mg-25 mg (benserazide)	Oral	100	5	RO
	Tablet 100 mg-25 mg (benserazide)	Oral	100	5	RO
	Tablet 200 mg-50 mg (benserazide)	Oral	100	5	RO
	Capsule 50 mg-12.5 mg (benserazide)	Oral	100	5	RO
	Capsule 100 mg-25 mg (benserazide)	Oral	100	5	RO
	Capsule 100 mg-25 mg (benserazide) (sustained release)	Oral	100	5	RO
	Capsule 200 mg-50 mg (benserazide)	Oral	100	5	RO
Levodopa with Carbidopa	Tablet 200 mg-50 mg (anhydrous) (modified release)	Oral	100	5	MK
	Tablet 100 mg-25 mg (anhydrous)	Oral	100	5	AF, MK
	Tablet 250 mg-25 mg (anhydrous)	Oral	100	5	HX, MK
Levodopa with Carbidopa and Entacapone	Tablet 50 mg-12.5 mg-200 mg Tablet 100 mg-25 mg-200 mg	Oral Oral	200 200	4 4	NV NV
	Tablet 150 mg-37.5 mg-200 mg	Oral	200	4	NV
Levonorgestrel	Tablets 30 micrograms, 28	Oral	4	2	SC, WY
	Intrauterine drug delivery system 52 mg	Intrauterine	1	..	SC
Levonorgestrel with Ethinyloestradiol	Pack containing 21 tablets 125 micrograms-50 micrograms and 7 inert tablets	Oral	4	2	SC
	Tablets 150 micrograms-30 micrograms, 21	Oral	4	2	SC
	Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets	Oral	4	2	SC, SY, WX, WY
	Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets	Oral	4	2	SC, SY, WX, WY
Lignocaine Hydrochloride	Injection 100 mg in 5 mL	Injection	5	..	PF
	Infusion 500 mg in 5 mL ampoule	Injection	10	..	AP
Lincomycin Hydrochloride	Injection equivalent to 600 mg lincomycin in 2 mL vial	Injection	5	..	PH
Liothyronine Sodium	Tablet 20 micrograms	Oral	100	2	SI
Lisinopril	Tablet 5 mg	Oral	30	5	AF, AP, AW, BF, CH, GM, GX, HX, MK, TW
	Tablet 10 mg	Oral	30	5	AF, AP, AW, BF, CH, GM, GX, HX, MK, TW
	Tablet 20 mg	Oral	30	5	AF, AP, AW, BF, CH, GM, GX, HX, MK, TW
Lithium Carbonate	Tablet 250 mg	Oral	200	2	AS
	Tablet 450 mg (slow release)	Oral	200	2	GK
"Locasol"	Low calcium compound powder 400 g	Oral	8	5	NU
Loperamide Hydrochloride	Capsule 2 mg	Oral	12	..	AS, JC
"Lophlex"	Sachets containing oral powder 27.8 g, 30	Oral	3	5	SB
"Lophlex LQ"	Oral liquid 125 mL, 30	Oral	3	5	SB
Lumiracoxib	Tablet 200 mg	Oral	30	3	NV
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride	Sachets containing powder for oral solution 13.125 g-350.7 mg-178.5 mg-46.6 mg, 30	Oral	1	5	NE
"Mapleflex"	Sachets containing oral powder 29 g, 30	Oral	4	5	SB
Medroxyprogesterone Acetate	Tablet 500 mg	Oral	30	2	PH
	Tablet 100 mg	Oral	100	2	PH
	Tablet 200 mg	Oral	60	2	PH
	Tablet 250 mg	Oral	60	2	PH
	Tablet 5 mg	Oral	56	2	KR, PH
	Tablet 10 mg	Oral	30	2	HX, KR, PH
	Injection 50 mg in 1 mL vial	Injection	1	1	PH
	Injection 150 mg in 1 mL vial	Injection	1	1	KR, PH
Mefenamic Acid	Capsule 250 mg	Oral	50	2	PD
Megestrol Acetate	Tablet 160 mg	Oral	30	2	BQ
Meloxicam	Tablet 7.5 mg	Oral	30	3	AW, BY
	Tablet 15 mg	Oral	30	3	AW, BY
	Capsule 7.5 mg	Oral	30	3	BY
	Capsule 15 mg	Oral	30	3	BY
Melphalan	Tablet 2 mg	Oral	25	1	GK
Mercaptopurine	Tablet 50 mg	Oral	100	2	GK
Mesalazine	Tablet 250 mg	Oral	100	5	GK
	Tablet 500 mg (enteric coated)	Oral	100	5	OA
	Sachet containing granules, 500 mg per sachet	Oral	100	5	OA
	Sachet containing granules, 1 g per sachet	Oral	100	2	OA
	Suppositories 1 g, 28	Rectal	1	..	FP
	Enemas 1 g in 100 mL, 7	Rectal	4	..	FP
	Enemas 2 g in 60 mL, 7	Rectal	4	..	OA
	Enemas 4 g in 60 mL, 7	Rectal	4	..	OA
	Rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g	Rectal	4	..	OA
Mesna	Solution for I.V. injection 400 mg in 4 mL ampoule	Injection	15	5	BX
	Solution for I.V. injection 1 g in 10 mL ampoule	Injection	15	5	BX
"Metabolic Mineral Mixture"	Oral powder 250 g	Oral	1	5	SB
Metformin Hydrochloride	Tablet 500 mg	Oral	100	5	AF, AL, AW, BF, CH, GM, GN, GX, HX, MQ, TW
	Tablet 500 mg (extended release)	Oral	90	5	AL
	Tablet 850 mg	Oral	60	5	AF, AL, AW, BF, CH, GM, GN, GX, HX, MQ, TW
	Tablet 1 g	Oral	90	5	AF, AL, AW
Metformin Hydrochloride with Glibenclamide	Tablet 250 mg-1.25 mg Tablet 500 mg-2.5 mg	Oral Oral	90 90	5 5	AL AL
	Tablet 500 mg-5 mg	Oral	90	5	AL
Methadone Hydrochloride	Tablet 10 mg	Oral	20	..	GK
	Injection 10 mg in 1 mL ampoule	Injection	5	..	GK
Methotrexate	Tablet 2.5 mg	Oral	30	5	MX, PH
	Tablet 10 mg	Oral	50	2	PH
	Injection 5 mg in 2 mL vial	Injection	5	..	MX
	Injection 50 mg in 2 mL vial	Injection	5	..	MX, PU
	Solution concentrate for I.V. infusion 500 mg in 5 mL vial	Injection	1	..	IT
	Solution concentrate for I.V. infusion 500 mg in 20 mL vial	Injection	1	..	MX
	Solution concentrate for I.V. infusion 1000 mg in 10 mL vial	Injection	1	..	IT, MX
	Solution concentrate for I.V. infusion 5000 mg in 50 mL vial	Injection	1	..	IT
Methyldopa	Tablet 250 mg	Oral	100	5	AF, MK
Methylphenidate Hydrochloride	Tablet 10 mg	Oral	100	5	AF, NV
Methylprednisolone Aceponate	Cream 1 mg per g, 15 g	Application	1	..	CS
	Ointment 1 mg per g, 15 g	Application	1	..	CS
	Fatty ointment 1 mg per g, 15 g	Application	1	..	CS
	Lotion 1 mg per g, 20 g	Application	1	..	CS
Methylprednisolone Acetate	Injection 40 mg in 1 mL vial	Injection	5	..	KR, PH
Methylprednisolone Sodium Succinate	Powder for injection equivalent to 40 mg methylprednisolone with diluent	Injection	5	..	PF
	Powder for injection equivalent to 1 g methylprednisolone with diluent	Injection	1	..	PF
Methysergide Maleate	Tablet equivalent to 1 mg methysergide	Oral	100	2	NV
Metoclopramide Hydrochloride	Tablet 10 mg	Oral	25	..	AF, VT
	Oral solution 5 mg per 5 mL, 100 mL	Oral	1	..	VT
	Injection 10 mg in 2 mL ampoule	Injection	10	..	VT
Metoprolol Succinate	Pack containing 15 tablets 23.75 mg (controlled release), 15 tablets 47.5 mg (controlled release) and 15 tablets 95 mg (controlled release)	Oral	1	..	AP
	Tablet 23.75 mg (controlled release)	Oral	15	..	AP
	Tablet 47.5 mg (controlled release)	Oral	30	5	AP
	Tablet 95 mg (controlled release)	Oral	30	5	AP
	Tablet 190 mg (controlled release)	Oral	30	5	AP
Metoprolol Tartrate	Tablet 50 mg	Oral	100	5	AF, AP, AW, CH, GM, GX, HX, NV, TW
	Tablet 100 mg	Oral	60	5	AF, AP, AW, CH, GM, GX, HX, NV, TW
Metronidazole	Tablet 200 mg	Oral	21	1	AF, AV, HP
	Tablet 400 mg	Oral	5	2	AF
	I.V. infusion 500 mg in 100 mL	Injection	5	1	BX
	Suppositories 500 mg, 10	Rectal	1	..	AV
Metronidazole Benzoate	Oral suspension 320 mg per 5 mL, 100 mL	Oral	1	..	AV
Mexiletine Hydrochloride	Capsule 50 mg	Oral	100	5	BY
	Capsule 200 mg	Oral	100	5	BY
Mianserin Hydrochloride	Tablet 10 mg	Oral	50	5	AF, OR
	Tablet 20 mg	Oral	50	5	AF, OR
Miconazole	Tincture 20 mg per mL, 30 mL	Application	1	2	JC
Miconazole Nitrate	Cream 20 mg per g, 15 g	Application	2	3	JC
	Cream 20 mg per g, 30 g	Application	1	2	JC
	Cream 20 mg per g, 70 g	Application	1	1	JC
	Powder 20 mg per g, 30 g	Application	1	2	JC
	Lotion 20 mg per mL, 30 g	Application	1	2	JC
"Minaphlex"	Sachets containing oral powder 29 g, 30	Oral	4	5	SB
Minocycline Hydrochloride	Tablet equivalent to 50 mg minocycline	Oral	60	5	AF, SI
	Capsule equivalent to 100 mg minocycline	Oral	11	..	AF
Minoxidil	Tablet 10 mg	Oral	100	5	PH
Mirtazapine	Tablet 15 mg (orally disintegrating)	Oral	30	5	BP
	Tablet 30 mg	Oral	30	5	AF, AW, BP, GM, OR
	Tablet 30 mg (orally disintegrating)	Oral	30	5	BP
	Tablet 45 mg	Oral	30	5	AW, BP
	Tablet 45 mg (orally disintegrating)	Oral	30	5	BP
Misoprostol	Tablet 200 micrograms	Oral	120	2	PH
Mitozantrone Hydrochloride	Injection equivalent to 10 mg mitozantrone in 5 mL vial	Injection	1	..	PU
	Injection equivalent to 20 mg mitozantrone in 10 mL vial	Injection	1	..	BX, MX, PU, SI
	Injection equivalent to 25 mg mitozantrone in 12.5 mL vial	Injection	1	..	BX, PU, SI
Moclobemide	Tablet 150 mg	Oral	60	5	AF, AL, CH, GM, GX, HX, RO, TW
	Tablet 300 mg	Oral	60	5	AF, AL, CH, GM, GX, HX, RO, SI, TW
Modafinil	Tablet 100 mg	Oral	120	5	CS
Mometasone Furoate	Cream 1 mg per g, 15 g	Application	1	..	EX, SH
	Ointment 1 mg per g, 15 g	Application	1	..	EX, SH
	Lotion 1 mg per g, 30 mL	Application	1	..	EX, SH
"Monogen"	Oral powder 400 g	Oral	8	5	SB
Montelukast Sodium	Tablet, chewable, equivalent to 4 mg montelukast	Oral	28	5	MK
	Tablet, chewable, equivalent to 5 mg montelukast	Oral	28	5	MK
Morphine Hydrochloride	Oral solution 2 mg per mL, 200 mL	Oral	1	..	MF
	Oral solution 5 mg per mL, 200 mL	Oral	1	..	MF
	Oral solution 10 mg per mL, 200 mL	Oral	1	..	MF
Morphine Sulfate	Tablet 10 mg	Oral	20	..	MF
	Tablet 20 mg	Oral	20	..	MF
	Tablet 30 mg	Oral	20	..	FM
	Tablet 5 mg (controlled release)	Oral	20	..	MF
	Tablet 10 mg (controlled release)	Oral	20	..	MF
	Tablet 15 mg (controlled release)	Oral	20	..	MF
	Tablet 30 mg (controlled release)	Oral	20	..	MF
	Tablet 60 mg (controlled release)	Oral	20	..	MF
	Tablet 100 mg (controlled release)	Oral	20	..	MF
	Tablet 200 mg (controlled release)	Oral	20	..	MF
	Capsule 10 mg (containing sustained release pellets)	Oral	20	..	GK
	Capsule 20 mg (containing sustained release pellets)	Oral	20	..	GK
	Capsule 30 mg (controlled release)	Oral	10	..	MF
	Capsule 50 mg (containing sustained release pellets)	Oral	20	..	GK
	Capsule 60 mg (controlled release)	Oral	10	..	MF
	Capsule 90 mg (controlled release)	Oral	10	..	MF
	Capsule 100 mg (containing sustained release pellets)	Oral	20	..	GK
	Capsule 120 mg (controlled release)	Oral	10	..	MF
	Sachet containing controlled release granules for oral suspension, 20 mg per sachet	Oral	20	..	MF
	Sachet containing controlled release granules for oral suspension, 30 mg per sachet	Oral	20	..	MF
	Sachet containing controlled release granules for oral suspension, 60 mg per sachet	Oral	20	..	MF
	Sachet containing controlled release granules for oral suspension, 100 mg per sachet	Oral	20	..	MF
	Sachet containing controlled release granules for oral suspension, 200 mg per sachet	Oral	20	..	MF
	Injection 10 mg in 1 mL ampoule	Injection	5	..	MX
	Injection 15 mg in 1 mL ampoule	Injection	5	..	MX
	Injection 30 mg in 1 mL ampoule	Injection	5	..	MX
Morphine Tartrate	Injection 120 mg in 1.5 mL ampoule	Injection	5	..	MX
Moxonidine	Tablet 200 micrograms	Oral	30	5	SM
	Tablet 400 micrograms	Oral	30	5	SM
"MSUD AID III"	Oral powder 500 g	Oral	4	5	SB
"MSUD Analog"	Oral powder 400 g	Oral	8	5	SB
"MSUD Express"	Sachets containing oral powder 25 g, 30	Oral	4	5	VF
"MSUD Maxamaid"	Oral powder 500 g	Oral	8	5	SB
"MSUD Maxamum"	Oral powder 500 g	Oral	8	5	SB
"MSUD-gel"	Sachets containing oral powder 20 g, 30	Oral	4	5	VF
Mycophenolate Mofetil	Capsule 250 mg	Oral	300	3	RO
	Tablet 500 mg	Oral	150	3	RO
Mycophenolate Mofetil with Water - Purified BP	Powder for oral suspension 1 g per 5 mL, 165 mL	Oral	1	3	RO
Mycophenolate Sodium	Tablet (enteric coated) equivalent to 180 mg mycophenolic acid	Oral	120	3	NV
	Tablet (enteric coated) equivalent to 360 mg mycophenolic acid	Oral	120	3	NV
Nafarelin Acetate	Nasal spray (pump pack) equivalent to 200 micrograms nafarelin per dose, 60 doses	Nasal	1	5	PH
Naloxone Hydrochloride	Injection 800 micrograms in 2 mL disposable injection set	Injection	1	..	CS
	Injection 2 mg in 5 mL disposable injection set	Injection	1	..	CS
Naltrexone Hydrochloride	Tablet 50 mg	Oral	30	1	BQ
Nandrolone Decanoate	Injection 50 mg in 1 mL disposable syringe	Injection	1	7	OR
Naproxen	Tablet 250 mg	Oral	100	3	AF, RO
	Tablet 500 mg	Oral	50	3	AF, RO
	Tablet 750 mg (sustained release)	Oral	28	3	MD, RO
	Tablet 1 g (sustained release)	Oral	28	3	MD, RO
	Oral suspension 125 mg per 5 mL, 474 mL	Oral	1	3	RO
Naproxen Sodium	Tablet 550 mg	Oral	50	3	MD, RO
Naratriptan Hydrochloride	Tablet equivalent to 2.5 mg naratriptan	Oral	4	5	GK
Nedocromil Sodium	Pressurised inhalation 2 mg per dose, 112 doses (CFC-free formulation)	Inhalation by mouth	1	5	AV
"Neocate"	Oral powder 400 g	Oral	8	5	SB
"Neocate Advance"	Oral powder 400 g	Oral	8	5	SB
Neomycin Sulfate	Tablet 500 mg	Oral	25	1	AF
Neomycin Undecenoate with Bacitracin Zinc	Ear ointment 12 mg (3.5 mg neomycin)-400 units per g, 10 g	Application to the ear	1	..	HA
Nicorandil	Tablets 10 mg, 60	Oral	1	5	AV
	Tablets 20 mg, 60	Oral	1	5	AV
Nifedipine	Tablet 10 mg	Oral	60	5	AF, AW, BN
	Tablet 20 mg	Oral	60	5	AF, AW, BN, CH, GM, GX, HX, TW
	Tablet 20 mg (controlled release)	Oral	30	5	BN
	Tablet 30 mg (controlled release)	Oral	30	5	AF, AW, BN
	Tablet 60 mg (controlled release)	Oral	30	5	AF, AW, BN
Nilutamide	Tablet 150 mg	Oral	30	5	AV
Nitrazepam	Tablet 5 mg	Oral	25	..	AF, VT
Nitrofurantoin	Capsule 50 mg	Oral	30	1	PU
	Capsule 100 mg	Oral	30	1	PU
Nizatidine	Capsule 150 mg	Oral	60	5	AF, AS, LN
	Capsule 300 mg	Oral	30	5	AF, AS, LN
Norethisterone	Tablets 350 micrograms, 28	Oral	4	2	JC, KR, PH
	Tablet 5 mg	Oral	30	2	SC
Norethisterone with Ethinyloestradiol	Tablets 500 micrograms-35 micrograms, 21	Oral	4	2	PH
	Pack containing 21 tablets 500 micrograms-35 micrograms and 7 inert tablets	Oral	4	2	KR, PH
	Tablets 1 mg-35 micrograms, 21	Oral	4	2	PH
	Pack containing 21 tablets 1 mg-35 micrograms and 7 inert tablets	Oral	4	2	KR, PH
	Pack containing 12 tablets 500 micrograms-35 micrograms, 9 tablets 1 mg-35 micrograms and 7 inert tablets	Oral	4	2	KR, PH
Norethisterone with Mestranol	Tablets 1 mg-50 micrograms, 21	Oral	4	2	PH
	Pack containing 21 tablets 1 mg-50 micrograms and 7 inert tablets	Oral	4	2	PH
Norfloxacin	Tablet 400 mg	Oral	14	1	AF, AW, CH, GM, GX, HX, MK, TW
Nortriptyline Hydrochloride	Tablet equivalent to 10 mg nortriptyline	Oral	50	2	AS
	Tablet equivalent to 25 mg nortriptyline	Oral	50	2	AS
Nystatin	Tablet 500,000 units	Oral	50	..	SI
	Capsule 500,000 units	Oral	50	..	SI
	Oral suspension 100,000 units per mL, 24 mL	Oral	1	1	BQ, SI
	Cream 100,000 units per g, 15 g	Application	2	3	BQ
Oestradiol	Tablet 2 mg	Oral	56	2	SM
	Transdermal patches 390 micrograms, 8	Transdermal	1	5	NV
	Transdermal patches 2 mg, 4	Transdermal	1	5	MM, SC
	Transdermal patches 2 mg, 8	Transdermal	1	5	NV
	Transdermal patches 585 micrograms, 8	Transdermal	1	5	NV
	Transdermal patches 3.28 mg, 8	Transdermal	1	5	NV
	Transdermal patches 3.8 mg, 4	Transdermal	1	5	MM, SC
	Transdermal patches 4 mg, 8	Transdermal	1	5	NV
	Transdermal patches 780 micrograms, 8	Transdermal	1	5	NV
	Transdermal patches 4.33 mg, 8	Transdermal	1	5	NV
	Transdermal patches 5.7 mg, 4	Transdermal	1	5	SC
	Transdermal patches 1.17 mg, 8	Transdermal	1	5	NV
	Transdermal patches 6.57 mg, 8	Transdermal	1	5	NV
	Transdermal patches 7.6 mg, 4	Transdermal	1	5	MM, SC
	Transdermal patches 8 mg, 8	Transdermal	1	5	NV
	Transdermal patches 1.56 mg, 8	Transdermal	1	5	NV
	Transdermal patches 8.66 mg, 8	Transdermal	1	5	NV
	Vaginal tablets 25 micrograms, 15	Vaginal	1	2	NO
Oestradiol and Oestradiol with Dydrogesterone	Pack containing 14 tablets oestradiol 2 mg and 14 tablets oestradiol 2 mg with dydrogesterone 10 mg	Oral	1	5	SM
Oestradiol and Oestradiol with Norethisterone Acetate	Pack containing 12 tablets oestradiol 2 mg, 10 tablets oestradiol 2 mg with norethisterone acetate 1 mg and 6 tablets oestradiol 1 mg	Oral	1	5	NO
	Pack containing 4 transdermal patches oestradiol 4 mg and 4 transdermal patches oestradiol 10 mg with norethisterone acetate 30 mg	Transdermal	1	5	NV
Oestradiol Hemihydrate	Nasal spray 150 micrograms per actuation, 60 actuations, 4.2 mL	Nasal	1	5	SE
	Transdermal gel equivalent to 1 mg oestradiol in 1 g sachet, 28	Transdermal	1	5	OR
	Transdermal patches equivalent to 750 micrograms oestradiol, 8	Transdermal	1	5	NV
	Transdermal patches equivalent to 1.5 mg oestradiol, 8	Transdermal	1	5	NV
	Transdermal patches equivalent to 3 mg oestradiol, 8	Transdermal	1	5	NV
Oestradiol Hemihydrate and Oestradiol Hemihydrate with Norethisterone Acetate	Pack containing 4 transdermal patches equivalent to 4.33 mg oestradiol and 4 transdermal patches equivalent to 620 micrograms oestradiol with 2.7 mg norethisterone acetate	Transdermal	1	5	NV
	Pack containing 4 transdermal patches equivalent to 4.33 mg oestradiol and 4 transdermal patches equivalent to 510 micrograms oestradiol with 4.8 mg norethisterone acetate	Transdermal	1	5	NV
Oestradiol Hemihydrate with Norethisterone Acetate	Tablets equivalent to 1 mg oestradiol with 500 micrograms norethisterone acetate, 28	Oral	1	5	NO
	Tablets equivalent to 2 mg oestradiol with 1 mg norethisterone acetate, 28	Oral	1	5	NO
	Transdermal patches equivalent to 620 micrograms oestradiol with 2.7 mg norethisterone acetate, 8	Transdermal	1	5	NV
	Transdermal patches equivalent to 510 micrograms oestradiol with 4.8 mg norethisterone acetate, 8	Transdermal	1	5	NV
Oestradiol Valerate	Tablet 1 mg	Oral	56	2	SC
	Tablet 2 mg	Oral	56	2	SC
Oestriol	Pessaries 500 micrograms, 15	Vaginal	1	2	OR
	Vaginal cream 1 mg per g, 15 g	Application	1	1	OR
Oestrogens—Conjugated	Tablet 300 micrograms	Oral	56	2	WY
	Tablet 625 micrograms	Oral	56	2	WY
Oestrogens—Conjugated with Medroxyprogesterone Acetate	Tablets 625 micrograms-2.5 mg, 28	Oral	1	5	WY
	Tablets 625 micrograms-5 mg, 28	Oral	1	5	WY
Ofloxacin	Eye drops 3 mg per mL, 5 mL	Application to the eye	2	..	AG
Olanzapine	Tablet 2.5 mg	Oral	30	5	LY
	Tablet 5 mg	Oral	30	5	LY
	Tablet 7.5 mg	Oral	30	5	LY
	Tablet 10 mg	Oral	30	5	LY
	Wafer 5 mg	Oral	28	5	LY
	Wafer 10 mg	Oral	28	5	LY
Olsalazine Sodium	Capsule 250 mg	Oral	100	5	UC
	Tablet 500 mg	Oral	100	5	UC
Omeprazole	Tablet 20 mg	Oral	30	1	HX, SL
	Capsule 20 mg	Oral	30	1	SZ
Omeprazole and Clarithromycin and Amoxycillin Trihydrate	Pack containing 14 capsules omeprazole 20 mg, 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin trihydrate equivalent to 500 mg amoxycillin	Oral	1	..	AB
Omeprazole Magnesium	Tablet equivalent to 20 mg omeprazole	Oral	30	1	AL, AP, PM
	Tablet equivalent to 10 mg omeprazole	Oral	30	5	AP
Ondansetron	Wafer 4 mg	Oral	4	..	GK, HX, RE
	Wafer 8 mg	Oral	4	..	GK, HX, RE
Ondansetron Hydrochloride Dihydrate	Tablet equivalent to 4 mg ondansetron	Oral	4	..	AW, GK, HX, RE
	Tablet equivalent to 8 mg ondansetron	Oral	4	..	AW, GK, HX, RE
	Syrup equivalent to 4 mg ondansetron per 5 mL, 50 mL	Oral	1	1	GK
	I.V. injection equivalent to 4 mg ondansetron in 2 mL ampoule	Injection	1	..	GK, HX, RE
	I.V. injection equivalent to 8 mg ondansetron in 4 mL ampoule	Injection	1	..	GK, HX, RE
Oxaliplatin	Solution concentrate for I.V. infusion 50 mg in 10 mL	Injection	1	2	SW
	Powder for I.V. infusion 50 mg	Injection	1	2	IT, MX, SW
	Solution concentrate for I.V. infusion 100 mg in 20 mL	Injection	1	2	SW
	Powder for I.V. infusion 100 mg	Injection	1	2	IT, MX, SW
Oxandrolone	Tablet 2.5 mg	Oral	100	1	CS
Oxazepam	Tablet 15 mg	Oral	25	..	AF, SI
	Tablet 30 mg	Oral	25	..	AF, FM, SI
Oxcarbazepine	Tablet 150 mg	Oral	100	5	NV
	Tablet 300 mg	Oral	100	5	NV
	Tablet 600 mg	Oral	100	5	NV
	Oral suspension 60 mg per mL, 250 mL	Oral	2	5	NV
Oxprenolol Hydrochloride	Tablet 20 mg	Oral	100	5	AF
	Tablet 40 mg	Oral	100	5	AF
Oxybutynin Hydrochloride	Tablet 5 mg	Oral	100	5	AV
Oxycodone Hydrochloride	Tablet 5 mg	Oral	20	..	SI
	Capsule 5 mg	Oral	20	..	MF
	Capsule 10 mg	Oral	20	..	MF
	Capsule 20 mg	Oral	20	..	MF
	Oral solution 5 mg per 5 mL, 250 mL	Oral	1	..	MF
	Tablet 5 mg (controlled release)	Oral	20	..	MF
	Tablet 10 mg (controlled release)	Oral	20	..	MF
	Tablet 20 mg (controlled release)	Oral	20	..	MF
	Tablet 40 mg (controlled release)	Oral	20	..	MF
	Tablet 80 mg (controlled release)	Oral	20	..	MF
Oxycodone Pectinate	Suppository equivalent to 30 mg oxycodone	Rectal	12	..	PL
Paclitaxel	Solution concentrate for I.V. infusion 30 mg in 5 mL vial	Injection	5	..	BQ, IT, MX
	Solution concentrate for I.V. infusion 100 mg in 16.7 mL vial	Injection	2	..	BQ, IT, MX
	Solution concentrate for I.V. infusion 150 mg in 25 mL vial	Injection	2	..	BQ, IT, MX
	Solution concentrate for I.V. infusion 300 mg in 50 mL vial	Injection	1	..	BQ, IT, MX
Pancreatic Extract	Capsule (containing enteric coated minimicrospheres) providing not less than 5,000 BP units of lipase activity	Oral	500	10	SM
	Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity	Oral	500	10	SM
	Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity	Oral	200	10	SM
Pancrelipase	Capsule (containing enteric coated microspheres) providing not less than 10,000 BP units of lipase activity	Oral	500	10	OR
	Capsule (containing enteric coated microtablets) providing not less than 25,000 BP units of lipase activity	Oral	200	10	TM
Pantoprazole Sodium Sesquihydrate	Tablet (enteric coated), equivalent to 40 mg pantoprazole	Oral	30	2	PH
	Tablet (enteric coated), equivalent to 20 mg pantoprazole	Oral	30	5	PH
Paracetamol	Tablet 500 mg	Oral	100	1	AW, CH, FM, GM, HX, JT, PC, SW, TW
	Tablet 665 mg (modified release)	Oral	192	5	GC, ME
	Oral liquid 120 mg per 5 mL, 100 mL	Oral	1	2	SW
	Oral liquid 240 mg per 5 mL, 200 mL	Oral	1	2	SW
Paraffin - Soft White with Paraffin - Liquid	Eye ointment, compound, 3.5 g	Application to the eye	2	5	AQ, IQ
	Pack containing 2 tubes eye ointment, compound, 3.5 g	Application to the eye	1	5	AG, IQ, PE
Paroxetine Hydrochloride	Tablet equivalent to 20 mg paroxetine	Oral	30	5	AF, AW, CH, GK, GM, GX, SZ, TW
Pemetrexed Disodium Heptahydrate	Powder for I.V. infusion equivalent to 500 mg pemetrexed, vial	Injection	2	2	LY
Penicillamine	Tablet 125 mg	Oral	100	1	AL
	Tablet 250 mg	Oral	100	1	AL
"Pepti-Junior"	Oral powder 450 g	Oral	8	5	NU
Pergolide Mesylate	Tablet equivalent to 50 micrograms pergolide	Oral	100	..	AS
	Tablet equivalent to 250 micrograms pergolide	Oral	100	5	AS
	Tablet equivalent to 1 mg pergolide	Oral	100	5	AS
Perhexiline Maleate	Tablet 100 mg	Oral	100	5	SI
Pericyazine	Tablet 2.5 mg	Oral	100	5	AV
	Tablet 10 mg	Oral	100	5	AV
Perindopril Arginine	Tablet 2.5 mg	Oral	30	5	SE
	Tablet 5 mg	Oral	30	5	SE
	Tablet 10 mg	Oral	30	5	SE
Perindopril Erbumine	Tablet 2 mg	Oral	30	5	CH, GX, TW
	Tablet 4 mg	Oral	30	5	CH, GX, TW
	Tablet 8 mg	Oral	30	5	CH, GX, TW
Perindopril Erbumine with Indapamide Hemihydrate	Tablet 4 mg-1.25 mg	Oral	30	5	SE
Permethrin	Cream 50 mg per g, 30 g	Application	1	1	PC
Pethidine Hydrochloride	Injection 100 mg in 2 mL ampoule	Injection	5	..	MX
Phenelzine Sulfate	Tablet equivalent to 15 mg phenelzine	Oral	100	1	LM
"Phenex-1"	Oral powder 350 g	Oral	8	5	AB
"Phenex-2"	Oral powder 325 g	Oral	10	5	AB
	Oral powder 400 g	Oral	8	5	AB
Phenobarbitone	Tablet 30 mg	Oral	200	4	SI
Phenobarbitone Sodium	Injection 200 mg in 1 mL ampoule	Injection	5	..	FM
Phenoxybenzamine Hydrochloride	Capsule 10 mg	Oral	100	5	GH
Phenoxymethylpenicillin Benzathine	Oral suspension equivalent to 125 mg phenoxymethylpenicillin per 5 mL, 100 mL	Oral	2	..	FM, SI
	Oral suspension equivalent to 250 mg phenoxymethylpenicillin per 5 mL, 100 mL	Oral	2	..	FM, SI
Phenoxymethylpenicillin Potassium	Tablet equivalent to 250 mg phenoxymethylpenicillin	Oral	50	..	SI
	Tablet equivalent to 500 mg phenoxymethylpenicillin	Oral	50	..	SI
	Capsule equivalent to 250 mg phenoxymethylpenicillin	Oral	50	..	CS, FM, GM, HX
	Capsule equivalent to 500 mg phenoxymethylpenicillin	Oral	50	..	CS, FM, GM, HX
Phenytoin	Tablet 50 mg	Oral	200	2	PF
	Oral suspension 30 mg per 5 mL, 500 mL	Oral	1	3	PF
Phenytoin Sodium	Capsule 30 mg	Oral	200	2	PF
	Capsule 100 mg	Oral	200	2	PF
"Phlexy-10"	Capsules 500 mg, 200	Oral	16	5	SB
	Tablets 1 g, 75	Oral	24	5	SB
	Bars 42 g, 20	Oral	10	5	SB
"Phlexy-10 Drink Mix"	Sachets containing oral powder 20 g, 30	Oral	7	5	SB
Pilocarpine Hydrochloride	Eye drops 5 mg per mL, 15 mL	Application to the eye	1	5	AG, PE
	Eye drops 10 mg per mL, 15 mL	Application to the eye	1	5	AG, AQ, PE
	Eye drops 20 mg per mL, 15 mL	Application to the eye	1	5	AG, AQ, PE
	Eye drops 40 mg per mL, 15 mL	Application to the eye	1	5	AG, AQ, PE
	Eye drops 60 mg per mL, 15 mL	Application to the eye	1	5	AG, PE
Pimecrolimus	Cream 10 mg per g, 15 g	Application	1	1	NV
Pindolol	Tablet 5 mg	Oral	100	5	AF, NV
	Tablet 15 mg	Oral	50	5	AF, NV
Pioglitazone Hydrochloride	Tablet equivalent to 15 mg pioglitazone	Oral	28	5	LY
	Tablet equivalent to 30 mg pioglitazone	Oral	28	5	LY
	Tablet equivalent to 45 mg pioglitazone	Oral	28	5	LY
Piperazine Oestrone Sulfate	Tablet 730 micrograms	Oral	56	2	KR, PH
	Tablet 1.46 mg	Oral	56	2	KR, PH
Piroxicam	Dispersible tablet 10 mg	Oral	50	3	AF, GX, HX, PF
	Dispersible tablet 20 mg	Oral	25	3	AF, CH, GX, HX, PF, TW
	Capsule 10 mg	Oral	50	3	AF, CH, GX, PF, TW
	Capsule 20 mg	Oral	25	3	AF, CH, GX, PF, TW
Pizotifen Malate	Tablet equivalent to 500 micrograms pizotifen	Oral	100	2	NV
"PK AID II"	Oral powder 250 g	Oral	8	5	SB
"PKU Express Liquid"	Oral liquid 130 mL, 30	Oral	4	5	VF
"PKU-gel"	Sachets containing oral powder 20 g, 30	Oral	4	5	VF
"PKU-Express"	Sachets containing oral powder 25 g, 30	Oral	4	5	VF
Pneumococcal Vaccine - Polyvalent	Injection 0.5 mL vial (23 valent)	Injection	1	..	CS
Polyethylene Glycol 400 with Propylene Glycol	Eye drops 4 mg-3 mg per mL, 15 mL	Application to the eye	1	5	AQ
Polygeline	I.V. infusion 17.5 g per 500 mL with electrolytes, 500 mL	Injection	3	..	AE
Polyvinyl Alcohol	Eye drops 14 mg per mL, 15 mL	Application to the eye	1	5	AG, PE
	Eye drops 14 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative)	Application to the eye	1	5	AE
	Eye drops 30 mg per mL, 15 mL	Application to the eye	1	5	AG, PE
	Eye drops 30 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative)	Application to the eye	1	5	AE
Potassium Chloride	Tablet 600 mg (sustained release)	Oral	200	1	AS, NM, NV
Potassium Chloride with Potassium Bicarbonate	Tablet, effervescent, 14 mmol K+ and 8 mmol Cl-	Oral	60	1	AS, LN
Pravastatin Sodium	Tablet 10 mg	Oral	30	5	AF, AW, BQ, CH, GM, GX, RE, SZ, TW
	Tablet 20 mg	Oral	30	5	AF, AW, BQ, CH, GM, GX, RE, SZ, TW
	Tablet 40 mg	Oral	30	5	AF, AW, BQ, CH, GM, GX, RE, SZ, TW
	Tablet 80 mg	Oral	30	5	AW, BQ
Prazosin Hydrochloride	Tablet equivalent to 1 mg prazosin	Oral	100	5	AF, CH, GX, PF, TW
	Tablet equivalent to 2 mg prazosin	Oral	100	5	AF, CH, GX, PF, TW
	Tablet equivalent to 5 mg prazosin	Oral	100	5	AF, CH, GX, PF, TW
Prednisolone	Tablet 1 mg	Oral	100	4	AS, LN
	Tablet 5 mg	Oral	60	4	AS, FM
	Tablet 25 mg	Oral	30	4	AS, FM
Prednisolone Acetate with Phenylephrine Hydrochloride	Eye drops 10 mg-1.2 mg per mL, 10 mL	Application to the eye	1	2	AG
Prednisolone Sodium Phosphate	Oral solution equivalent to 5 mg prednisolone per mL, 30 mL	Oral	1	5	AS, LN
	Enema, retention, equivalent to 20 mg prednisolone in 100 mL	Rectal	28	3	SI
	Suppositories equivalent to 5 mg prednisolone, 10	Rectal	3	3	SI
Prednisone	Tablet 1 mg	Oral	100	4	AS, LN
	Tablet 5 mg	Oral	60	4	AS, FM
	Tablet 25 mg	Oral	30	4	AS, FM
Primidone	Tablet 250 mg	Oral	200	2	LM
"Pro-Phree"	Oral powder 400 g	Oral	8	5	AB
Probenecid	Tablet 500 mg	Oral	100	5	PL
Procaine Penicillin	Injection 1.5 g in disposable syringe	Injection	5	..	SI
Prochlorperazine	Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5	Rectal	1	2	AV
	Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5	Rectal	1	2	AV
Prochlorperazine Maleate	Tablet 5 mg	Oral	25	..	AV, HP
Prochlorperazine Mesylate	Injection 12.5 mg in 1 mL ampoule	Injection	10	..	AV
Promethazine Hydrochloride	Injection 50 mg in 2 mL ampoule	Injection	10	..	MX
Propantheline Bromide	Tablet 15 mg	Oral	200	5	SI
Propranolol Hydrochloride	Tablet 10 mg	Oral	100	5	AF, AP
	Tablet 40 mg	Oral	100	5	AF, AP
	Tablet 160 mg	Oral	50	5	AF
Propylthiouracil	Tablet 50 mg	Oral	200	2	PL
Pyrantel Embonate	Tablet equivalent to 125 mg pyrantel	Oral	6	..	AF
	Tablet equivalent to 250 mg pyrantel	Oral	6	..	AF
Pyridostigmine Bromide	Tablet 10 mg	Oral	100	5	VT
	Tablet 60 mg	Oral	150	5	VT
	Tablet 180 mg (modified release)	Oral	100	5	VT
Pyrimethamine	Tablet 25 mg	Oral	50	..	GK
Quetiapine Fumarate	Tablet equivalent to 25 mg quetiapine	Oral	60	5	AP
	Tablet equivalent to 100 mg quetiapine	Oral	90	5	AP
	Tablet equivalent to 200 mg quetiapine	Oral	60	5	AP
	Tablet equivalent to 300 mg quetiapine	Oral	60	5	AP
Quinagolide Hydrochloride	Pack containing 3 tablets equivalent to 25 micrograms quinagolide and 3 tablets equivalent to 50 micrograms quinagolide	Oral	1	..	FP
	Tablet equivalent to 75 micrograms quinagolide	Oral	30	5	FP
Quinapril Hydrochloride	Tablet equivalent to 5 mg quinapril	Oral	30	5	AF, AW, PF
	Tablet equivalent to 10 mg quinapril	Oral	30	5	AF, AW, PF
	Tablet equivalent to 20 mg quinapril	Oral	30	5	AF, AW, PF
Quinapril Hydrochloride with Hydrochlorothiazide	Tablet equivalent to 10 mg quinapril with 12.5 mg hydrochlorothiazide	Oral	30	5	PF
	Tablet equivalent to 20 mg quinapril with 12.5 mg hydrochlorothiazide	Oral	30	5	PF
Quinine Bisulfate	Tablet 300 mg	Oral	50	2	AS
Quinine Sulfate	Tablet 300 mg	Oral	50	2	AS, LN
Rabeprazole Sodium	Tablet 20 mg (enteric coated)	Oral	30	2	JC
	Tablet 10 mg (enteric coated)	Oral	28	5	JC
Raloxifene Hydrochloride	Tablet 60 mg	Oral	28	5	LY
Raltitrexed	Powder for I.V. infusion 2 mg in single use vial	Injection	3	2	AP
Ramipril	Tablet 1.25 mg	Oral	30	5	AV, ML, QM, WA
	Tablet 2.5 mg	Oral	30	5	AV, ML, QM, WA
	Tablet 5 mg	Oral	30	5	AV, ML, QM, WA
	Capsule 10 mg	Oral	30	5	AV, ML, QM, WA
	Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg	Oral	1	..	AV
Ranitidine Hydrochloride	Tablet equivalent to 150 mg ranitidine	Oral	60	5	AF, CH, GK, GM, GX, HX, RA, SI, TW
	Tablet, effervescent, equivalent to 150 mg ranitidine	Oral	60	5	GK
	Tablet equivalent to 300 mg ranitidine	Oral	30	5	AF, CH, GK, GM, GX, HX, RA, SI, TW
	Syrup equivalent to 150 mg ranitidine per 10 mL, 300 mL	Oral	2	5	GK
"RCF"	Oral liquid 384 mL	Oral	120	5	AB
Reboxetine Mesilate	Tablet equivalent to 4 mg reboxetine	Oral	60	5	PH
Reteplase	Pack containing 2 vials powder for injection 10 units, 2 single use pre-filled syringes with solvent, 2 reconstitution spikes and 2 needles	Injection	1	..	RO
Rifampicin	Capsule 150 mg	Oral	10	..	AF
	Capsule 300 mg	Oral	10	..	AF
	Syrup 100 mg per 5 mL, 60 mL	Oral	1	..	AV
Riluzole	Tablet 50 mg	Oral	56	5	AV
Risedronate Sodium	Tablet 5 mg	Oral	28	5	AV
	Tablet 35 mg	Oral	4	5	AV
	Tablet 30 mg	Oral	28	1	AV
Risedronate Sodium and Calcium Carbonate	Pack containing 4 tablets risedronate sodium 35 mg and 24 tablets calcium carbonate 1.25 g (equivalent to 500 mg calcium)	Oral	1	5	AV
Risperidone	Tablet 0.5 mg	Oral	60	2	JC
	Tablet 0.5 mg (orally disintegrating)	Oral	56	2	JC
	Tablet 1 mg	Oral	60	2	JC
	Tablet 1 mg (orally disintegrating)	Oral	56	2	JC
	Tablet 2 mg	Oral	60	5	JC
	Tablet 2 mg (orally disintegrating)	Oral	56	5	JC
	Tablet 3 mg	Oral	60	5	JC
	Tablet 4 mg	Oral	60	5	JC
	Oral solution 1 mg per mL, 30 mL	Oral	1	2	JC
	Oral solution 1 mg per mL, 100 mL	Oral	1	5	JC
	I.M. injection (modified release), set containing 1 vial powder for injection 25 mg and 1 pre-filled syringe diluent 2 mL	Injection	2	5	JC
	I.M. injection (modified release), set containing 1 vial powder for injection 37.5 mg and 1 pre-filled syringe diluent 2 mL	Injection	2	5	JC
	I.M. injection (modified release), set containing 1 vial powder for injection 50 mg and 1 pre-filled syringe diluent 2 mL	Injection	2	5	JC
Rituximab	Solution for I.V. infusion 100 mg in 10 mL vial	Injection	2	3	RO
	Solution for I.V. infusion 500 mg in 50 mL vial	Injection	1	3	RO
Rivastigmine Hydrogen Tartrate	Capsule equivalent to 1.5 mg rivastigmine	Oral	56	5	NV
	Capsule equivalent to 3 mg rivastigmine	Oral	56	5	NV
	Capsule equivalent to 4.5 mg rivastigmine	Oral	56	5	NV
	Capsule equivalent to 6 mg rivastigmine	Oral	56	5	NV
	Oral solution equivalent to 2 mg rivastigmine per mL, 120 mL	Oral	1	5	NV
Rosiglitazone Maleate	Tablet equivalent to 4 mg rosiglitazone	Oral	28	5	GK
	Tablet equivalent to 8 mg rosiglitazone	Oral	28	5	GK
Rosiglitazone Maleate with Metformin Hydrochloride	Tablet equivalent to 2 mg rosiglitazone with 500 mg metformin hydrochloride	Oral	56	5	GK
	Tablet equivalent to 2 mg rosiglitazone with 1 g metformin hydrochloride	Oral	56	5	GK
	Tablet equivalent to 4 mg rosiglitazone with 500 mg metformin hydrochloride	Oral	56	5	GK
	Tablet equivalent to 4 mg rosiglitazone with 1 g metformin hydrochloride	Oral	56	5	GK
Rosuvastatin Calcium	Tablet equivalent to 5 mg rosuvastatin	Oral	30	5	AP
	Tablet equivalent to 10 mg rosuvastatin	Oral	30	5	AP
	Tablet equivalent to 20 mg rosuvastatin	Oral	30	5	AP
	Tablet equivalent to 40 mg rosuvastatin	Oral	30	5	AP
Roxithromycin	Tablet for oral suspension 50 mg	Oral	10	1	AV
	Tablet 150 mg	Oral	10	1	AF, AV, AW, HP, HX
	Tablet 300 mg	Oral	5	1	AF, AV, AW, HP, HX
"S-26 LF"	Infant formula powder 900 g	Oral	5	..	WY
Salbutamol Sulfate	Oral solution equivalent to 2 mg salbutamol per 5 mL, 150 mL	Oral	2	5	GK
	Capsule containing powder for oral inhalation equivalent to 200 micrograms salbutamol (for use in Ventolin Rotahaler)	Inhalation by mouth	200	5	GK
	Pressurised inhalation equivalent to 100 micrograms salbutamol per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	2	5	AL, AW, GK, MM
	Pressurised inhalation in breath actuated device equivalent to 100 micrograms salbutamol per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	2	5	MM
	Nebuliser solution equivalent to 2.5 mg salbutamol in 2.5 mL single dose units, 30	Inhalation	2	5	AF, AW, CH, GK, GX, PU, TW
	Nebuliser solution equivalent to 5 mg salbutamol in 2.5 mL single dose units, 30	Inhalation	2	5	AF, AW, CH, GK, GX, TW
	Nebuliser solution equivalent to 5 mg salbutamol per mL, 30 mL	Inhalation	2	2	PU
Salcatonin	Injection 50 I.U. in 1 mL ampoule	Injection	30	5	NV
	Injection 100 I.U. in 1 mL ampoule	Injection	15	5	NV
Salmeterol Xinafoate	Pressurised inhalation equivalent to 25 micrograms salmeterol per dose, 120 doses	Inhalation by mouth	1	5	GK
	Powder for oral inhalation in breath actuated device equivalent to 50 micrograms salmeterol per dose, 60 doses	Inhalation by mouth	1	5	GK
Selegiline Hydrochloride	Tablet 5 mg	Oral	100	5	AF, GM
Sertraline Hydrochloride	Tablet equivalent to 50 mg sertraline	Oral	30	5	AF, AW, CH, GM, GX, PF, RA, SZ, TW
	Tablet equivalent to 100 mg sertraline	Oral	30	5	AF, AW, CH, GM, GX, PF, RA, SZ, TW
Silver Sulfadiazine with Chlorhexidine Gluconate	Cream 10 mg-2 mg per g, 50 g	Application	1	..	SN
	Cream 10 mg-2 mg per g, 100 g	Application	1	..	SN
Simvastatin	Tablet 5 mg	Oral	30	5	AF, BF, FR, HX, MK, RE
	Tablet 10 mg	Oral	30	5	AF, AW, BF, CH, FR, GM, GN, GX, HX, MK, RE, TW
	Tablet 20 mg	Oral	30	5	AF, AW, BF, CH, FR, GM, GN, GX, HX, MK, RE, TW
	Tablet 40 mg	Oral	30	5	AF, AW, BF, CH, FR, GM, GN, GX, HX, MK, RE, TW
	Tablet 80 mg	Oral	30	5	AF, AW, BF, CH, FR, GM, GN, GX, HX, MK, RE, TW
Sirolimus	Tablet 1 mg	Oral	100	3	WY
	Tablet 2 mg	Oral	100	3	WY
	Oral solution 1 mg per mL, 60 mL	Oral	1	3	WY
Sodium Acid Phosphate	Tablet, compound effervescent, equivalent to 500 mg phosphorus	Oral	100	5	NV
Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate	Oral liquid 1 g-320 mg-534 mg in 20 mL, 500 mL	Oral	2	5	RC
Sodium Aurothiomalate	Injection 10 mg ampoule	Injection	10	..	AV
	Injection 20 mg ampoule	Injection	10	1	AV
	Injection 50 mg ampoule	Injection	10	1	AV
Sodium Chloride	Injection 9 mg per mL, 10 mL	Injection	5	1	PF
	I.V. infusion 154 mmol per L, 1 L	Injection	5	1	BX
	I.V. infusion 513 mmol per L, 1 L	Injection	2	1	BX
Sodium Chloride with Glucose	I.V. infusion 31 mmol-222 mmol (anhydrous) per L, 1 L	Injection	5	1	BX
	I.V. infusion 19 mmol-104 mmol (anhydrous) per 500 mL, 500 mL	Injection	5	1	BX
	I.V. infusion 39 mmol-69 mmol (anhydrous) per 500 mL, 500 mL	Injection	5	1	BX
Sodium Chloride with Potassium Chloride and Calcium Chloride	I.V. infusion containing approximately 148 mmol Na+, 4 mmol K+, 2 mmol Ca2+ and 156 mmol Cl- per L, 1 L	Injection	4	1	BX
Sodium Chloride with Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride	Electrolyte replacement solution 5.26 g-3.68 g-5.02 g- 370 mg-300 mg per L, 1 L	Injection	2	1	BX
Sodium Clodronate Tetrahydrate	Capsule equivalent to 400 mg sodium clodronate	Oral	100	2	SC
	Tablet equivalent to 800 mg sodium clodronate	Oral	60	2	SC
Sodium Cromoglycate	Capsule containing powder for oral inhalation 20 mg (for use in Intal Spinhaler or Intal Halermatic)	Inhalation by mouth	100	5	GM
	Solution for inhalation 20 mg in 2 mL ampoule	Inhalation	120	3	AV
	Pressurised inhalation 1 mg per dose, 200 doses	Inhalation by mouth	1	5	AV
	Pressurised inhalation 1 mg per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	1	5	AV
	Pressurised inhalation 5 mg per dose, 112 doses (CFC-free formulation)	Inhalation by mouth	1	5	AV
	Eye drops 20 mg per mL, 10 mL	Application to the eye	1	5	AE, AV
Sodium Fusidate	Tablet 250 mg	Oral	36	1	CS
Sodium Lactate with Sodium Chloride, Potassium Chloride and Calcium Chloride	I.V. infusion containing approximately 131 mmol Na+, 5 mmol K+, 2 mmol Ca2+, 29 mmol HCO3- (as lactate) and 111 mmol Cl- per L, 1 L	Injection	5	1	BX
Sodium Valproate	Tablet, crushable, 100 mg	Oral	200	2	SW
	Tablet 200 mg (enteric coated)	Oral	200	2	AF, SW
	Tablet 500 mg (enteric coated)	Oral	200	2	AF, SW
	Oral liquid 200 mg per 5 mL, 300 mL	Oral	2	2	SW
	Oral solution 200 mg per 5 mL, 300 mL	Oral	2	2	SW
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate	Enemas 3.125 g-450 mg-45 mg in 5 mL, 12	Rectal	2	2	PH
Sotalol Hydrochloride	Tablet 80 mg	Oral	60	5	AW, BQ, GX, HX
	Tablet 160 mg	Oral	60	5	AF, AW, BQ, CH, GM, GX, HX, TW
Spironolactone	Tablet 25 mg	Oral	100	5	AF, PH
	Tablet 100 mg	Oral	100	5	AF, PH
Sterculia with Frangula Bark	Granules 620 mg-80 mg per g, 500 g	Oral	1	1	NE
Sucralfate	Tablet equivalent to 1 g anhydrous sucralfate	Oral	120	2	AF, AS
Sulfacetamide Sodium	Eye drops 100 mg per mL, 15 mL	Application to the eye	1	2	AG
Sulfasalazine	Tablet 500 mg	Oral	200	5	PH
	Tablet 500 mg (enteric coated)	Oral	200	5	KR, PH
Sulindac	Tablet 100 mg	Oral	100	3	AF
	Tablet 200 mg	Oral	50	3	AF
Sulthiame	Tablet 50 mg	Oral	200	2	PL
	Tablet 200 mg	Oral	200	2	PL
Sumatriptan	Nasal spray 20 mg in 0.1 mL single dose unit	Nasal	2	5	GK
Sumatriptan Succinate	Tablet equivalent to 50 mg sumatriptan	Oral	4	5	GK, ME
	Tablet (fast disintegrating) equivalent to 50 mg sumatriptan	Oral	4	5	GK
Tacrolimus	Capsule 500 micrograms	Oral	100	3	JC
	Capsule 1 mg	Oral	100	3	JC
	Capsule 5 mg	Oral	50	3	JC
Tamoxifen Citrate	Tablet equivalent to 10 mg tamoxifen	Oral	60	5	AF, AP, GM
	Tablet equivalent to 20 mg tamoxifen	Oral	60	5	AF, AP, CH, GM, GX, HX, SI, TW
Telmisartan	Tablet 40 mg	Oral	28	5	BY
	Tablet 80 mg	Oral	28	5	BY
Telmisartan with Hydrochlorothiazide	Tablet 40 mg-12.5 mg Tablet 80 mg-12.5 mg	Oral Oral	28 28	5 5	BY BY
Temazepam	Tablet 10 mg	Oral	25	..	AF, FM, SI
Temozolomide	Capsule 5 mg	Oral	15	2	SH
	Capsule 20 mg	Oral	15	2	SH
	Capsule 100 mg	Oral	15	2	SH
	Capsule 250 mg	Oral	5	5	SH
Tenecteplase	Powder for injection 40 mg vial with solvent	Injection	1	..	BY
	Powder for injection 50 mg vial with solvent	Injection	1	..	BY
Terbinafine Hydrochloride	Tablet equivalent to 250 mg terbinafine	Oral	42	1	AF, AW, GM, GX, NV, SZ
Terbutaline Sulfate	Injection 500 micrograms in 1 mL ampoule	Injection	5	..	AP
	Powder for oral inhalation in breath actuated device 500 micrograms per dose, 200 doses	Inhalation by mouth	1	5	AP
	Nebuliser solution 5 mg in 2 mL single dose units, 30	Inhalation	2	5	AP
Testosterone	Subcutaneous implant 100 mg	Subcutaneous implantation	6	..	OR
	Subcutaneous implant 200 mg	Subcutaneous implantation	3	..	OR
	Transdermal gel 50 mg in 5 g sachet, 30	Transdermal	1	5	SC
	Transdermal patches 12.2 mg, 60	Transdermal	1	5	MX
	Transdermal patches 24.3 mg, 30	Transdermal	1	5	MX
Testosterone Enanthate	Injection 250 mg in 1 mL	Injection	3	3	SC
Testosterone Propionate with Testosterone Phenylpropionate and Testosterone Isocaproate	Injection 20 mg-40 mg-40 mg in 1 mL ampoule	Injection	3	3	OR
Testosterone Propionate with Testosterone Phenylpropionate, Testosterone Isocaproate and Testosterone Decanoate	Injection 30 mg-60 mg-60 mg-100 mg in 1 mL ampoule	Injection	3	3	OR
Testosterone Undecanoate	Capsule 40 mg	Oral	60	5	OR
	I.M. injection 1,000 mg in 4 mL	Injection	1	1	SC
Tetrabenazine	Tablet 25 mg	Oral	112	5	OA
Tetracosactrin	Compound depot injection 1 mg in 1 mL ampoule	Injection	5	5	NV
Theophylline	Tablet 200 mg (sustained release)	Oral	100	5	MM
	Tablet 250 mg (sustained release)	Oral	100	5	MM
	Tablet 300 mg (sustained release)	Oral	100	5	MM
	Oral solution 133.3 mg per 25 mL, 500 mL	Oral	1	5	MM
Thiamine Hydrochloride	Tablet 100 mg	Oral	100	2	AV
Thioguanine	Tablet 40 mg	Oral	25	1	GK
Thioridazine Hydrochloride	Tablet 10 mg	Oral	100	5	AF
	Tablet 25 mg	Oral	100	5	AF
	Tablet 50 mg	Oral	100	5	AF
	Tablet 100 mg	Oral	100	5	AF
Thiotepa	Powder for injection 15 mg	Injection or intravesical administration	2	1	SI
Thyroxine Sodium	Tablet equivalent to 50 micrograms anhydrous thyroxine sodium	Oral	200	1	FM, SI
	Tablet equivalent to 100 micrograms anhydrous thyroxine sodium	Oral	200	1	FM, SI
	Tablet equivalent to 200 micrograms anhydrous thyroxine sodium	Oral	200	1	FM, SI
Tiagabine Hydrochloride	Tablet equivalent to 5 mg tiagabine	Oral	100	5	MX
	Tablet equivalent to 10 mg tiagabine	Oral	100	5	MX
	Tablet equivalent to 15 mg tiagabine	Oral	100	5	MX
Tiaprofenic Acid	Tablet 300 mg	Oral	60	3	AV
Ticarcillin Sodium with Potassium Clavulanate with any determined brand of Sodium Chloride Injection	Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid (with required solvent)	Injection	10	..	GK
Ticlopidine Hydrochloride	Tablet 250 mg	Oral	60	5	AF, HX, RO
Tiludronate Disodium	Tablet equivalent to 200 mg tiludronic acid	Oral	56	2	MX
Timolol Maleate	Eye gel equivalent to 1 mg timolol per g, 5 g	Application to the eye	1	5	NV
	Eye drops equivalent to 2.5 mg timolol per mL, 5 mL	Application to the eye	1	5	FR, SI
	Eye drops equivalent to 5 mg timolol per mL, 5 mL	Application to the eye	1	5	FR, SI
	Eye drops (gellan gum solution) equivalent to 2.5 mg timolol per mL, 2.5 mL	Application to the eye	1	5	MK
	Eye drops (gellan gum solution) equivalent to 5 mg timolol per mL, 2.5 mL	Application to the eye	1	5	MK
Tinidazole	Tablet 500 mg	Oral	4	..	GP, PF
Tiotropium Bromide Monohydrate	Capsule containing powder for oral inhalation equivalent to 18 micrograms tiotropium (for use in HandiHaler)	Inhalation by mouth	30	5	BY
Tirofiban Hydrochloride	Solution concentrate for I.V. infusion equivalent to 12.5 mg tirofiban in 50 mL vial	Injection	1	2	MK
Tobramycin	Eye drops 3 mg per mL, 5 mL	Application to the eye	1	2	AQ
	Eye ointment 3 mg per g, 3.5 g	Application to the eye	1	..	AQ
Tobramycin Sulfate	Injection equivalent to 80 mg tobramycin in 2 mL (with preservative)	Injection	10	1	MX
	Injection equivalent to 80 mg tobramycin in 2 mL (without preservative)	Injection	10	1	PU
Topiramate	Tablet 25 mg	Oral	60	5	JC
	Tablet 50 mg	Oral	60	5	JC
	Tablet 100 mg	Oral	60	5	JC
	Tablet 200 mg	Oral	60	5	JC
	Capsule 15 mg	Oral	60	5	JC
	Capsule 25 mg	Oral	60	5	JC
	Capsule 50 mg	Oral	60	5	JC
Topotecan Hydrochloride	Powder for I.V. infusion equivalent to 4 mg topotecan, vial	Injection	5	1	GK
Toremifene Citrate	Tablet equivalent to 60 mg toremifene	Oral	30	5	SH
Tramadol Hydrochloride	Capsule 50 mg	Oral	20	..	AF, AW, CH, CS, GX, TW
	Tablet 50 mg (sustained release)	Oral	20	..	CS
	Tablet 100 mg (sustained release)	Oral	20	..	AW, CS, HX
	Tablet 150 mg (sustained release)	Oral	20	..	AW, CS, HX
	Tablet 200 mg (sustained release)	Oral	20	..	AW, CS, HX
	Oral drops 100 mg per mL, 10 mL	Oral	1	..	CS
	Injection 100 mg in 2 mL ampoule	Injection	5	..	CS, HX
Trandolapril	Capsule 500 micrograms	Oral	28	5	AB, KN
	Capsule 1 mg	Oral	28	5	AB, KN
	Capsule 2 mg	Oral	28	5	AB, KN
	Capsule 4 mg	Oral	28	5	AB
Tranexamic Acid	Tablet 500 mg	Oral	100	2	PH
Tranylcypromine Sulfate	Tablet equivalent to 10 mg tranylcypromine	Oral	50	2	GH
Travoprost	Eye drops 40 micrograms per mL, 2.5 mL	Application to the eye	1	5	AQ
Travoprost with Timolol Maleate	Eye drops 40 micrograms travoprost with timolol maleate equivalent to 5 mg timolol per mL, 2.5 mL	Application to the eye	1	5	AQ
Triamcinolone Acetonide	Injection 10 mg in 1 mL ampoule	Injection	5	..	BQ
	Cream 200 micrograms per g, 100 g	Application	2	..	FM, SI
	Ointment 200 micrograms per g, 100 g	Application	2	..	FM, SI
Triamcinolone Acetonide with Neomycin Sulfate, Gramicidin and Nystatin	Ear drops 1 mg-2.5 mg (neomycin)-250 micrograms-100,000 units per g, 7.5 mL	Application to the ear	1	2	BC, BQ
	Ear ointment 1 mg-2.5 mg (neomycin)-250 micrograms-100,000 units per g, 5 g	Application to the ear	1	2	BC, BQ
Trifluoperazine Hydrochloride	Tablet equivalent to 1 mg trifluoperazine	Oral	100	5	GH
	Tablet equivalent to 2 mg trifluoperazine	Oral	100	5	GH
	Tablet equivalent to 5 mg trifluoperazine	Oral	100	5	GH
Triglycerides Oil - Medium Chain	500 mL	Oral	2	5	SB
Trimethoprim	Tablet 300 mg	Oral	7	1	AF, SI
Trimethoprim with Sulfamethoxazole	Tablet 80 mg-400 mg Tablet 160 mg-800 mg	Oral Oral	10 10	1 1	AF, SI AF, CH, GX, RO, SI, TW
	Tablet 80 mg-400 mg Tablet 160 mg-800 mg	Oral Oral	10 10	1 1	AF, SI AF, CH, GX, RO, SI, TW
	Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL	Oral	1	1	AF, RO, SI
Tropisetron Hydrochloride	Capsule equivalent to 5 mg tropisetron	Oral	2	..	NV
	I.V. injection equivalent to 5 mg tropisetron in 5 mL ampoule	Injection	1	..	NV
"TYR gel"	Sachets containing oral powder 20 g, 30	Oral	4	5	VF
"TYR Express"	Sachets containing oral powder 25 g, 30	Oral	4	5	VF
Ursodeoxycholic Acid	Capsule 250 mg	Oral	100	2	OA
Valaciclovir Hydrochloride	Tablet equivalent to 500 mg valaciclovir	Oral	20	..	GK
Vancomycin Hydrochloride	Capsule equivalent to 125 mg (125,000 I.U.) vancomycin activity	Oral	40	..	LY
	Capsule equivalent to 250 mg (250,000 I.U.) vancomycin activity	Oral	40	..	LY
	Powder for injection equivalent to 500 mg (500,000 I.U.) vancomycin activity	Injection	2	..	AS, MX
Venlafaxine Hydrochloride	Capsule (modified release) equivalent to 37.5 mg venlafaxine	Oral	28	..	WY
	Capsule (modified release) equivalent to 75 mg venlafaxine	Oral	28	5	WY
	Capsule (modified release) equivalent to 150 mg venlafaxine	Oral	28	5	WY
Verapamil Hydrochloride	Tablet 40 mg	Oral	100	5	AB, AF
	Tablet 80 mg	Oral	100	5	AB, AF
	Tablet 120 mg	Oral	100	5	AB
	Tablet 160 mg	Oral	60	5	AB
	Tablet 180 mg (sustained release)	Oral	30	5	AB, KN
	Tablet 240 mg (sustained release)	Oral	30	5	AB, AF, KN
	Capsule 160 mg (sustained release)	Oral	30	5	SI
	Capsule 240 mg (sustained release)	Oral	30	5	SI
	Injection 5 mg in 2 mL ampoule	Injection	5	..	AB
Vigabatrin	Tablet 500 mg	Oral	100	5	AV
	Oral powder, sachet 500 mg	Oral	60	5	AV
Vinblastine Sulfate	Solution for I.V. injection 10 mg in 10 mL vial	Injection	5	..	MX
Vincristine Sulfate	I.V. injection 1 mg in 1 mL vial	Injection	10	..	MX, PU
Vinorelbine Tartrate	Capsule equivalent to 20 mg vinorelbine	Oral	20	2	FB
	Capsule equivalent to 30 mg vinorelbine	Oral	16	2	FB
	Solution for I.V. infusion equivalent to 10 mg vinorelbine in 1 mL	Injection	16	2	FB, IT, MX
	Solution for I.V. infusion equivalent to 50 mg vinorelbine in 5 mL	Injection	4	2	FB, IT, MX
Warfarin Sodium	Tablet 1 mg	Oral	50	2	FM, SI
	Tablet 2 mg	Oral	50	2	SI
	Tablet 3 mg	Oral	50	2	FM
	Tablet 5 mg	Oral	50	2	FM, SI
"XMET Analog"	Oral powder 400 g	Oral	8	5	SB
"XMET Maxamaid"	Oral powder 500 g	Oral	8	5	SB
"XMET Maxamum"	Oral powder 500 g	Oral	8	5	SB
"XMTVI Analog"	Oral powder 400 g	Oral	8	5	SB
"XMTVI Asadon"	Oral powder 200 g	Oral	5	5	SB
"XMTVI Maxamaid"	Oral powder 500 g	Oral	8	5	SB
"XMTVI Maxamum"	Oral powder 500 g	Oral	8	5	SB
"XP Analog"	Oral powder 400 g	Oral	8	5	SB
"XP Analog LCP"	Oral powder 400 g	Oral	8	5	SB
"XP Maxamaid"	Oral powder 500 g	Oral	8	5	SB
"XP Maxamum"	Sachets containing oral powder 50 g, 30	Oral	3	5	SB
	Oral powder 500 g	Oral	8	5	SB
"XPhen, Tyr Analog"	Oral powder 400 g	Oral	8	5	SB
"XPhen, Tyr Maxamaid"	Oral powder 500 g	Oral	8	5	SB
"XPhen, Tyr Maxamum"	Oral powder 500 g	Oral	8	5	SB
"XPTM Tyrosidon"	Oral powder 500 g	Oral	4	5	SB
Zolmitriptan	Tablet 2.5 mg	Oral	4	5	AP
Zuclopenthixol Decanoate	Oily I.M. injection 200 mg in 1 mL ampoule	Injection	5	..	LU

Aciclovir	Tablet 200 mg	In compliance with authority procedures set out in subparagraph 11 (d): Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Oral	90	5	AF, CH, GK, GM, GX, HX, RA, TW

	Tablet 800 mg	In compliance with authority procedures set out in subparagraph 11 (d): Patients with advanced human immunodeficiency virus disease (CD4 cell counts of less than 150 million per L)	Oral	120	5	AF, GK, GM, HX

Adalimumab	Injection 40 mg in 0.8 mL pre-filled syringe	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 November 2004, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to an inability to receive concomitant methotrexate, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight	Injection	2	5	AB

		Commencement of adalimumab treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with adalimumab prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 May 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab detailed below; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight
		Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with adalimumab; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with adalimumab; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of adalimumab therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
	Injection 40 mg in 0.8 mL pre-filled syringe	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight	Injection	2	3	AB

		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and (3) have not failed treatment with adalimumab during the current Treatment Cycle; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with adalimumab within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with adalimumab, to their most recent course of PBS-subsidised adalimumab treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment at a dose that does not exceed 40 mg per fortnight In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
	Injection 40 mg in 0.8 mL pre-filled syringe	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and (2) were receiving treatment with adalimumab prior to 16 March 2006; and (3) have demonstrated a response to adalimumab treatment as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgment form; the course of treatment is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight; patients are eligible for PBS-subsidised treatment under the above criteria once only In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight	Injection	2	5	AB

		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: (1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and (3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to treatment with adalimumab is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of adalimumab therapy was a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment at a dose that does not exceed 40 mg per fortnight In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total, at a dose that does not exceed 40 mg per fortnight
Adrenaline	I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the name of the specialist consulted is included in the authority application	Injection	2	..	CS

		Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times
		Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the patient has previously been issued with an authority prescription for this drug
	I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been assessed to be at significant risk of anaphylaxis by, or in consultation with, a clinical immunologist, allergist, paediatrician or respiratory physician, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the name of the specialist consulted is included in the authority application	Injection	2	..	CS

		Initial supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years who has been discharged from hospital or an emergency department after treatment with adrenaline for acute allergic reaction with anaphylaxis, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times
		Continuing supply for anticipated emergency treatment of acute allergic reactions with anaphylaxis in a patient aged less than 17 years, where a quantity of 2 adrenaline auto-injectors is necessary to ensure 1 is on hand at all times, and where the patient has previously been issued with an authority prescription for this drug
Albendazole	Tablet 200 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	6	1	GK
		Treatment of tapeworm infestation
Amlodipine Besylate	Tablet equivalent to 5 mg amlodipine	In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs	Oral	30	5	PF
		Drug interactions occurring with all of the base-priced drugs
		Drug interactions expected to occur with all of the base-priced drugs
		Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
	Tablet equivalent to 10 mg amlodipine	In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs	Oral	30	5	PF
		Drug interactions occurring with all of the base-priced drugs
		Drug interactions expected to occur with all of the base-priced drugs
		Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
Amoxycillin Trihydrate with Water - Purified BP	Powder for paediatric oral drops equivalent to 100 mg amoxycillin per mL, 20 mL	In compliance with authority procedures set out in subparagraph 11 (d): Treatment of infections suspected or proven to be due to a susceptible organism in patients who require a liquid formulation and in whom the syrup formulations are unsuitable	Oral	1	1	GK
Anakinra	Injection 100 mg in 0.67 mL single use pre-filled syringe	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 July 2004 and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment	Injection	28	5	AN

		Commencement of anakinra treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with anakinra prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 December 2004 due to testing negative for rheumatoid factor, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with anakinra detailed below; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment
		Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with anakinra; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with anakinra; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the patient receives concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly; patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; if this treatment cycle is the patient's first bDMARD treatment cycle and the patient has failed to demonstrate a response to PBS-subsidised treatment with adalimumab, etanercept and infliximab commenced prior to 1 December 2004, the patient is eligible to continue PBS-subsidised therapy with anakinra in this first treatment cycle, despite having previously failed to respond to 3 bDMARDs; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with anakinra, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of anakinra therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who are receiving concomitant treatment with methotrexate at a dose of at least 7.5 mg weekly and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Azithromycin Dihydrate	Tablet equivalent to 500 mg azithromycin	Trachoma	Oral	2	2	PF
Benzathine Penicillin	Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector)	Syphilis	Injection	2	..	AS
	Powder for injection 900 mg	Syphilis	Injection	2	..	AS
Bromocriptine Mesylate	Tablet equivalent to 2.5 mg bromocriptine	Acromegaly Parkinson's disease	Oral	60	5	AF, NV
		Pathological hyperprolactinaemia where surgery is not indicated
		Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
		Pathological hyperprolactinaemia where radiotherapy is not indicated
		Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
Buprenorphine	Transdermal patch 5 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Transdermal	4	..	MF
		Chronic severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Transdermal patch 10 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Transdermal	4	..	MF
		Chronic severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Transdermal patch 20 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Transdermal	4	..	MF
		Chronic severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Bupropion Hydrochloride	Tablet 150 mg (sustained release)	In compliance with authority procedures set out in subparagraph 11 (d): Completion of treatment as short-term adjunctive therapy for nicotine dependence to facilitate the goal of achieving abstinence in patients who have indicated that they are ready to cease smoking and who have entered a comprehensive support and counselling program, and where the patient has previously been issued with an authority prescription for commencement of treatment with this drug	Oral	90	..	GK, HX, RE

Cabergoline	Tablet 500 micrograms	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	8	5	PH
		Pathological hyperprolactinaemia where surgery is not indicated
		Pathological hyperprolactinaemia where surgery has already been used with incomplete resolution
		Pathological hyperprolactinaemia where radiotherapy is not indicated
		Pathological hyperprolactinaemia where radiotherapy has already been used with incomplete resolution
Ceftriaxone Sodium	Powder for injection equivalent to 500 mg ceftriaxone	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent Septicaemia, suspected	Injection	5	..	IZ
		Septicaemia, proven
Chorionic Gonadotrophin	Injection set containing 3 ampoules powder for injection 500 units and 3 ampoules solvent 1 mL	Cryptorchism not due to organic obstruction in boys over 12 months of age	Injection	2	1	OR
Ciprofloxacin Hydrochloride	Tablet equivalent to 250 mg ciprofloxacin	In compliance with authority procedures set out in subparagraph 11 (d): Respiratory tract infection proven or suspected to be caused by Pseudomonas aeruginosa in severely immunocompromised patients	Oral	14	..	AL, AW, BG, BN, GX, HX
		Bacterial gastroenteritis in severely immunocompromised patients
		Treatment of infections proven to be due to Pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials
		Treatment of joint and bone infections, epididymo-orchitis, prostatitis or perichondritis of the pinna, suspected or proven to be caused by gram-negative bacteria or gram-positive bacteria resistant to all other appropriate antimicrobials
Codeine Phosphate with Paracetamol	Tablet 30 mg-500 mg	In compliance with authority procedures set out in subparagraph 11 (d): Treatment (for up to 6 months) of severe disabling pain not responding to non-narcotic analgesics, at a dose not exceeding 8 tablets per day	Oral	60	..	AL, CO, DK, FM, GK, SW
Cyproterone Acetate	Tablet 50 mg	In compliance with authority procedures set out in subparagraph 11 (d): Advanced carcinoma of the prostate To reduce drive in sexual deviations in males	Oral	100	5	AF, GM, GX, HX, SC, SY
Dalteparin Sodium	Injection 2,500 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe	Haemodialysis	Injection	20	3	PH
	Injection 5,000 I.U. (anti-Xa) in 0.2 mL single dose pre-filled syringe	Haemodialysis	Injection	20	3	PH
	Injection 7,500 I.U. (anti-Xa) in 0.75 mL single dose pre-filled syringe	Haemodialysis	Injection	20	3	PH
Desmopressin Acetate	Tablet 200 micrograms	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	90	5	FP
		Cranial diabetes insipidus
	Nasal spray (pump pack) 10 micrograms per actuation, 60 actuations, 6 mL	In compliance with authority procedures set out in subparagraph 11 (d): Cranial diabetes insipidus	Nasal	2	5	FP
Diazepam	Tablet 2 mg	In compliance with authority procedures set out in subparagraph 11 (d): Disabling spasticity	Oral	100	..	AF, AW, RO, SU
		Malignant neoplasia (late stage)
		For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
		For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
	Tablet 5 mg	In compliance with authority procedures set out in subparagraph 11 (d): Disabling spasticity Malignant neoplasia (late stage)	Oral	100	..	AF, AW, GM, RO, SU
		For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
		For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
"Digestelact"	Oral powder 900 g	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	3	10	SJ
		Proven chronic lactose intolerance in children aged 1 year and over who are significantly malnourished, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet
Doxycycline Hydrochloride	Tablet equivalent to 100 mg doxycycline	Pelvic inflammatory disease	Oral	28	..	AF, GM, PF, SI
	Capsule equivalent to 100 mg doxycycline (containing enteric coated pellets)	Pelvic inflammatory disease	Oral	28	..	FA, MX
	Tablet equivalent to 100 mg doxycycline	Urethritis	Oral	21	..	AF, GM, PF, SI
	Capsule equivalent to 100 mg doxycycline (containing enteric coated pellets)	Urethritis	Oral	21	..	FA, MX
Doxycycline Monohydrate	Tablet equivalent to 100 mg doxycycline	Pelvic inflammatory disease	Oral	28	..	CH, GX, SZ, TW
	Tablet equivalent to 100 mg doxycycline	Urethritis	Oral	21	..	CH, GX, SZ, TW
Efalizumab	Injection set containing 4 vials powder for injection 125 mg and 4 pre-filled syringes diluent 1.3 mL	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of efalizumab for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over who: (a) have a documented history of severe chronic plaque psoriasis and were receiving treatment with efalizumab prior to 10 November 2005; and (b) had a Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing treatment with efalizumab; and (c) have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with efalizumab; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of efalizumab therapy) and the most recent PASI assessment; and (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form; the most recent PASI assessment is no more than 1 month old at the time of application; the course of treatment is limited to a maximum of 24 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis, who were receiving non-PBS-subsidised treatment with efalizumab prior to 10 November 2005, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total	Injection	1	5	SG

		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with efalizumab; and (c) who have demonstrated an adequate response to their most recent course of treatment with efalizumab; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to efalizumab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, after at least 12 weeks of efalizumab treatment, when compared with the baseline value for this Treatment Cycle established prior to biological agent treatment; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: (i) the assessment of response is conducted following at least 12 weeks of therapy, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course; and (ii) the response assessment is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and whole body area diagrams along with the date of the assessment of the patient's condition; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Commencement of a Biological Treatment Cycle with an initial PBS-subsidised course of efalizumab for continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin) by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and were receiving treatment with efalizumab prior to 10 November 2005; and (b) whose disease, prior to treatment with efalizumab, was classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where either at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling were rated as severe or very severe, or the skin area affected was 30% or more of the face, palm of a hand or sole of a foot; and (c) who have signed a patient acknowledgement form indicating that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the relevant restriction for continuing PBS-subsidised treatment; and (d) who have demonstrated a response as specified in the criterion included in the relevant restriction for continuing PBS-subsidised treatment with efalizumab; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition at baseline (prior to initiation of efalizumab therapy) and the most recent PASI assessment; and (ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and (iii) a copy of the signed patient acknowledgement form; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; the most recent PASI assessment is no more than 1 month old at the time of application; the course of treatment is limited to a maximum of 24 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of a course of initial PBS-subsidised treatment as systemic monotherapy, commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, who were receiving non-PBS-subsidised treatment with efalizumab prior to 10 November 2005, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Continuing treatment as systemic monotherapy (i.e. not in conjunction with acitretin, methotrexate or cyclosporin), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with efalizumab; and (c) who have demonstrated an adequate response to their most recent course of treatment with efalizumab; and where biological agent means efalizumab or etanercept; and where a Biological Treatment Cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with a biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a biological agent up to 3 times (but with the same biological agent no more than twice), at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to efalizumab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, after at least 12 weeks of efalizumab treatment, as compared to the baseline values established prior to biological agent treatment; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, after at least 12 weeks of efalizumab treatment, as compared to the baseline value established prior to biological agent treatment; the PASI assessment is performed on the same affected body area assessed to establish the baseline pre-treatment PASI score; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: (i) the assessment of response is conducted following at least 12 weeks of therapy, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course; and (ii) the response assessment is submitted to the Medicare Australia CEO no later than 1 month from the date that course of treatment ceased; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes a copy of the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuing treatment as systemic monotherapy, within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
"EleCare"	Oral powder 400 g	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	8	5	AB
		Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
		Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
		Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
		Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
Enoxaparin Sodium	Injection 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe	Haemodialysis	Injection	20	3	AV
	Injection 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe	Haemodialysis	Injection	20	3	AV
	Injection 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe	Haemodialysis	Injection	20	3	AV
Escitalopram Oxalate	Oral solution equivalent to 10 mg escitalopram per mL, 28 mL	In compliance with authority procedures set out in subparagraph 11 (d): Major depressive disorders, where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme	Oral	1	5	LU

		Major depressive disorders, where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Major depressive disorders, where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
		Major depressive disorders, where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
Esomeprazole Magnesium Trihydrate	Tablet (enteric coated), equivalent to 20 mg esomeprazole	Maintenance of healed gastro-oesophageal reflux disease	Oral	30	5	AP
Etanercept	Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment commencing a treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: (a) who have not received any treatment with either etanercept or infliximab subsidised under the Pharmaceutical Benefits Scheme (PBS), or, where the patient has previously received PBS-subsidised treatment with either of these drugs, have not received PBS-subsidised treatment with etanercept or infliximab for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and (b) who, where the patient has received non-PBS-subsidised treatment with etanercept or infliximab, have not received non-PBS-subsidised treatment with etanercept prior to 1 July 2004; and (c) who have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; and (d) who have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), in combination with an appropriate exercise program, for a total period of at least 3 months, unless: (i) treatment with NSAIDs is contraindicated according to the relevant Therapeutic Goods Administration (TGA)-approved Product Information, in which case the patient is exempt from the NSAID component of the combined NSAID and exercise treatment regimen specified above; or (ii) adverse events of a severity necessitating permanent treatment withdrawal develop during the relevant period of use of 2 NSAIDs, in which case the patient may be exempted from the NSAID component of the combined NSAID and exercise treatment regimen specified above; or (iii) the patient is unable to complete the minimum exercise program, in which case the patient is exempt from completing the exercise component of the combined NSAID and exercise treatment regimen specified above; or (iv) the patient has had a break in PBS-subsidised therapy with etanercept and infliximab of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months, instead of the combined NSAID and exercise regimen specified above; and (e) who have signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with etanercept and with infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response is demonstrated by: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L; both ESR and CRP measurements are included in the authority application and are no more than 1 month old; if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reasons why a higher dose cannot be used; where the patient is exempted from the minimum 3 months of treatment with at least 2 NSAIDs because treatment with NSAIDs is contraindicated, the authority application includes evidence supporting the contraindication; an appropriate minimum exercise program includes stretch and range of motion exercises 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; the application for authorisation includes: (a) a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a copy of the completed BASDAI Assessment Form; and (iii) a copy of the signed patient acknowledgment form; and (iv) a copy of the exercise program self-certification form detailing the program followed and the dates over which it was followed; and (b) confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed in the self-certification form; a course of initial treatment commencing a treatment cycle is limited to a maximum of 6 weeks of treatment	Injection	3	..	WY

		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis and who, in this treatment cycle, have received prior PBS-subsidised treatment with etanercept or with infliximab for this condition as 'new' patients and have not failed PBS-subsidised therapy with etanercept more than once; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where a 'new' patient is one who was not 'grandfathered' onto PBS-subsidised treatment with either etanercept or infliximab; and where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligibility criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and where the following conditions apply: patients who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; the authority application includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form; the application is accompanied by the results of the patient's most recent course of PBS-subsidised etanercept or infliximab therapy, where: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and (ii) if the most recent course of PBS-subsidised treatment is a 6 week course, the patient is assessed for response to that course no earlier than 4 weeks from the commencement of that course; a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 6 weeks of treatment
		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab and who have not failed PBS-subsidised therapy with etanercept more than once; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligibility criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and where the following conditions apply: patients who commenced PBS-subsidised treatment of ankylosing spondylitis with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; the authority application includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form; the application is accompanied by the results of the patient's most recent course of PBS-subsidised etanercept or infliximab therapy, where: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; and (ii) if the most recent course of PBS-subsidised treatment is a 6 week course, the patient is assessed for response to that course no earlier than 4 weeks from the commencement of that course; a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 6 weeks of treatment
	Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks or more of treatment with etanercept subsidised under the Pharmaceutical Benefits Scheme (PBS) as 'new' patients, who have demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where a 'new' patient is one who was not 'grandfathered' onto PBS-subsidised treatment with either etanercept or infliximab; and where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligiblity criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and where the following conditions apply: patients who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline; all measurements provided are no more than 1 month old at the time of application; the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured for all subsequent continuing treatment applications for the patient; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and (ii) if the course of therapy is a 6 week initial course, the assessment of response is made no earlier than 4 weeks from the commencement of that course; the application for authorisation includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form, including certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept as 'new' patients for a period of less than 24 weeks (other than a prescription for the first 4 weeks of continuing treatment immediately following an initial treatment course), and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total In compliance with authority procedures set out in subsubparagraph 11 (d)(ii): Continuing treatment, for up to 4 weeks, within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks of initial PBS-subsidised treatment with etanercept as 'new' patients immediately prior to this course of therapy and who, at the time of application, meet the criteria for continuing treatment with etanercept as specified above, and where a completed copy of the appropriate PBS Authority Application - Supporting Information Form (which includes a copy of the completed BASDAI Assessment Form) is submitted to the Medicare Australia CEO by facsimile	Injection	2	5	WY

		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Commencement of a treatment cycle with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were receiving treatment with etanercept prior to 1 July 2004; and (a) who are receiving treatment with etanercept at the time of application; and (b) who have not received prior PBS-subsidised treatment with infliximab; and (c) whose Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is less than or equal to 5 on a 0-10 scale; and (d) who have: (i) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or (ii) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or (iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; and (e) who have signed a patient acknowledgment form declaring that they understand and acknowledge that PBS-subsidised treatment with etanercept and with infliximab for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where the following conditions apply: the BASDAI assessment and the ESR and CRP measurements are no more than 1 month old at the time of application; the application for authorisation includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a copy of the completed BASDAI Assessment Form; and (iii) a copy of the signed patient acknowledgment form; the course of treatment is limited to a maximum of 24 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were receiving non-PBS-subsidised treatment with etanercept prior to 1 July 2004 and at the time of the initial application for PBS-subsidised therapy and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab, who have received 6 weeks or more of PBS-subsidised treatment with etanercept, who have demonstrated a response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and where a treatment cycle is a period of treatment which commences when an eligible patient (one who has not received PBS-subsidised treatment with etanercept or with infliximab for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with either etanercept or infliximab, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised courses of treatment with one or other drug up to 3 times (but with the same drug no more than twice), at which point the patient is no longer eligible for treatment with etanercept or infliximab for ankylosing spondylitis and the period of treatment ceases; and where to be 'grandfathered' onto PBS-subsidised treatment with infliximab or with etanercept means to be commenced on PBS-subsidised treatment under the eligiblity criteria specified for the initiation of PBS-subsidised treatment in patients who commenced non-PBS-subsidised treatment with infliximab prior to 1 March 2004 (where the patient is 'grandfathered' onto infliximab) or with etanercept prior to 1 July 2004 (where the patient is 'grandfathered' onto etanercept); and where the following conditions apply: patients who commenced PBS-subsidised treatment with etanercept or infliximab prior to 1 August 2005 are deemed to have commenced their first treatment cycle with that therapy and any PBS-subsidised treatment with either drug received prior to 1 August 2005 is deemed to be treatment received as part of the patient's first treatment cycle; response to treatment is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment, and: (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline; all measurements provided are no more than 1 month old at the time of application; the same acute phase reactant used to establish baseline at the commencement of an initial treatment course is measured for all subsequent continuing treatment applications for the patient; patients will be deemed to have failed to respond to treatment with a course of PBS-subsidised therapy, despite demonstrating a response as defined above, unless: (i) the response assessment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course of treatment ceased; and (ii) if the course of therapy is a 6 week initial course, the assessment of response is made no earlier than 4 weeks from the commencement of that course; the application for authorisation includes a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form which includes a copy of the completed BASDAI Assessment Form including certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuing treatment within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing PBS-subsidised treatment with etanercept for a period of less than 24 weeks (other than a prescription for the first 4 weeks of continuing treatment immediately following an initial treatment course), and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total In compliance with authority procedures set out in subsubparagraph 11 (d)(ii): Continuing treatment, for up to 4 weeks, within an ongoing treatment cycle, by a rheumatologist, of adults with active ankylosing spondylitis who have received 6 weeks or more of initial PBS-subsidised treatment with etanercept as 'grandfathered' patients immediately prior to this course of therapy and who, at the time of application, meet the criteria for continuing treatment with etanercept as specified above, and where a completed copy of the appropriate Tumour Necrosis Factor alfa antagonist PBS Authority Application - Supporting Information Form (which includes a copy of the completed BASDAI Assessment Form) is submitted to the Medicare Australia CEO by facsimile
	Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and (2) have not previously received PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months, unless the patient has had a break in PBS-subsidised biological agent treatment of at least 5 years, in which case the patient is required to achieve an adequate response to treatment with either methotrexate or sulfasalazine, at an adequate dose, for a minimum of 3 months; and (4) have had the psoriatic component of their disease confirmed by a dermatologist or by biopsy at any time; and (5) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of initial treatment in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total	Injection	2	3	WY

		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and who are eligible to receive further therapy with a biological agent within this Treatment Cycle; and (3) have not failed treatment with etanercept during the current Treatment Cycle; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this Treatment Cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response, as specified in the criteria for continuing PBS-subsidised treatment with etanercept, to their most recent course of PBS-subsidised etanercept treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy, where the most recent course of PBS-subsidised treatment was a 16-week initial treatment course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
	Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Commencement of a Biological Treatment Cycle, with an initial PBS-subsidised course of etanercept for continuing treatment, by a rheumatologist or by an immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months; and (2) were receiving treatment with etanercept prior to 17 March 2005; and (3) have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and (4) have signed a patient acknowledgement form declaring that they understand and acknowledge that PBS-subsidised treatment with a biological agent will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form which includes a copy of the signed patient acknowledgement form; the course of treatment is limited to a maximum of 24 weeks of treatment; patients are eligible for PBS-subsidised treatment under the above criteria once only In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of a course of initial PBS-subsidised treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status within the last 12 months, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial PBS-subsidised treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total	Injection	2	5	WY

		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Continuing treatment within an ongoing Biological Treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: (1) who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status; and (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and where biological agent means adalimumab or etanercept or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to treatment with etanercept is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of etanercept therapy was a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuing treatment within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis with a record of rheumatoid factor negative status, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
	Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and (b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless: (i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or (ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; a course of treatment is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total	Injection	2	3	WY

		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; patients are eligible to commence therapy with etanercept within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response to their most recent course of PBS-subsidised etanercept treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of etanercept therapy; a course of treatment is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and where the following conditions apply: failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy
	Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment in a biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) (i) who have not previously received treatment with a bDMARD for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS); or (ii) who, where the patient has previously received PBS-subsidised bDMARD treatment, have received no PBS-subsidised treatment with a bDMARD for this condition for a period of 5 years or more starting from the date the last course of PBS-subsidised bDMARD therapy was approved; and (b) who have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless: (i) treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to that particular agent (or agents) only; or (ii) the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and (c) who have signed a patient acknowledgement form declaring that they understand and acknowledge that, within a single bDMARD treatment cycle, PBS-subsidised treatment with any bDMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (b) above is demonstrated by an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L, and either a total active joint count of at least 20 active (swollen and tender) joints, or at least 4 active joints from the following list of major joints: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; where the patient is exempted from demonstrating an inadequate response to a treatment regimen specified at (b) above on the basis of contraindication or intolerance, the authority application includes details of the contraindication or intolerance, including the degree of toxicity; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form which includes details of the patient's ESR and CRP measurements, and an assessment of the patient's active joint count, conducted no earlier than 1 month prior to the date of application, and a copy of the signed patient acknowledgment form; a course of treatment is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of initial treatment in a bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total	Injection	1	3	WY

		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment or recommencement of treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who have received prior PBS-subsidised treatment with a bDMARD for this condition in this bDMARD treatment cycle and who are eligible to receive further bDMARD therapy within this treatment cycle; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; patients are eligible to commence therapy with etanercept within this bDMARD treatment cycle provided they have not already tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 bDMARDs within this treatment cycle, and provided they also meet the conditions applying to recommencement of etanercept therapy specified below, if applicable; patients who have previously commenced, and subsequently ceased, PBS-subsidised treatment with etanercept within this bDMARD treatment cycle are eligible to recommence therapy with this drug within this same cycle if: (i) they have demonstrated an adequate response to their most recent course of PBS-subsidised etanercept treatment; and (ii) the response was assessed, and the assessment was provided to the Medicare Australia CEO, no later than 4 weeks from the date that course ceased; and (iii) the response was assessed following a minimum of 12 weeks of therapy when the most recent course of PBS-subsidised treatment was an initial 16 week course; and (iv) response to treatment was determined using the same indices of disease severity used to establish baseline at the commencement of treatment; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form and, where this is required, evidence of the patient's response to their most recent course of etanercept therapy; a course of treatment is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuation of initial treatment, or of a course which recommences treatment, within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and where the following conditions apply: failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy
	Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment	Injection	2	5	WY

		Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with etanercept; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of etanercept therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient
		Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and where the following conditions apply: the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course
	Injection set containing 4 vials powder for injection 50 mg and 4 pre-filled syringes solvent 1 mL	In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Commencement of etanercept treatment in a bDMARD treatment cycle with an initial supply subsidised under the Pharmaceutical Benefits Scheme (PBS) for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who were receiving treatment with etanercept prior to 1 March 2005, who failed to qualify for PBS-subsidised therapy after 1 August 2003 due to testing negative for rheumatoid factor, and who have demonstrated a response to etanercept treatment as specified in the criteria for continuing PBS-subsidised treatment with etanercept detailed below; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient; the course of treatment is limited to a maximum of 24 weeks of treatment	Injection	1	5	WY

		Continuing treatment within an ongoing biological disease modifying anti-rheumatic drug (bDMARD) treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis, and: (a) who have demonstrated an adequate response to treatment with etanercept; and (b) whose most recent course of bDMARD treatment subsidised under the Pharmaceutical Benefits Scheme (PBS) in this bDMARD treatment cycle was with etanercept; and where bDMARD means a drug included in the following list of drugs: adalimumab, anakinra, etanercept or infliximab; and where a bDMARD treatment cycle is a period of treatment with successive bDMARDs which commences when an eligible patient (one who has not received PBS-subsidised treatment with a bDMARD for rheumatoid arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 bDMARD, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with a maximum of 3 bDMARDs, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients who commenced PBS-subsidised bDMARD treatment prior to 1 December 2004 are deemed to have commenced their first bDMARD treatment cycle with that therapy and any PBS-subsidised treatment received prior to 1 December 2004 is deemed to be treatment received as part of the patient's first bDMARD treatment cycle; an adequate response to treatment is defined as an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and either a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints, or a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as active if swollen and tender); or — shoulder or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of treatment are used to determine response; the authority application includes a completed copy of the appropriate Biological DMARD PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept, where response is assessed, and this assessment is provided to the Medicare Australia CEO, no later than 4 weeks from the cessation of that treatment course; if the most recent course of etanercept therapy was an initial 16 week course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; a course of treatment is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d)(i) or 11 (d)(ii): Continuing treatment within an ongoing bDMARD treatment cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
		In compliance with authority procedures set out in subsubparagraph 11 (d)(i): Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient
		Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline, and an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and where the following conditions apply: the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course
Famciclovir	Tablet 250 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	56	5	NV
		Suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
	Tablet 500 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	56	5	NV
		Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes in immunocompromised patients, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis
Fentanyl	Transdermal patch 2.1 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Transdermal	10	..	JC
		Chronic severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Transdermal patch 4.2 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Transdermal	10	..	JC
		Chronic severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Transdermal patch 8.4 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Transdermal	10	..	JC
		Chronic severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Transdermal patch 12.6 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Transdermal	10	..	JC
		Chronic severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Transdermal patch 16.8 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Transdermal	10	..	JC
		Chronic severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Granisetron Hydrochloride	Tablet equivalent to 2 mg granisetron	In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy	Oral	5	1	MX

	Concentrated injection equivalent to 3 mg granisetron in 3 mL ampoule	In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy	Injection	1	..	MX
Hydrocortisone Sodium Succinate	Injection equivalent to 100 mg hydrocortisone with 2 mL solvent	For use in a hospital	Injection	6	..	PH
	Injection equivalent to 250 mg hydrocortisone with 2 mL solvent	For use in a hospital	Injection	6	..	PH
Hydromorphone Hydrochloride	Tablet 2 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	40	..	AB
		Severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 4 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	40	..	AB
		Severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 8 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	40	..	AB
		Severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Oral liquid 1 mg per mL, 473 mL	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia	Oral	2	..	AB
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Ibuprofen	Tablet 400 mg	Chronic arthropathies (including osteoarthritis) with an inflammatory component	Oral	90	3	AB
		Bone pain due to malignant disease
Interferon Alfa-2a	Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe	In compliance with authority procedures set out in subparagraph 11 (d): Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy	Injection	15	5	RO

	Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe	In compliance with authority procedures set out in subparagraph 11 (d): Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy	Injection	5	5	RO
	Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe	In compliance with authority procedures set out in subparagraph 11 (d): Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy	Injection	5	5	RO

	Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe	In compliance with authority procedures set out in subparagraph 11 (d): Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy	Injection	5	5	RO

Interferon Alfa-2b	Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen	In compliance with authority procedures set out in subparagraph 11 (d): Maintenance treatment of multiple myeloma once remission has been achieved with chemotherapy	Injection	3	5	SH
		Low grade non-Hodgkin's lymphoma with clinical features suggestive of a poor prognosis, in combination with anthracycline-based chemotherapy
"Karicare De-Lact"	Oral powder 900 g	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	5	5	NU
		Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet
Ketoconazole	Tablet 200 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	30	5	JC
		Oral candidiasis in severely immunocompromised persons where topical therapy has failed
		Systemic or deep mycoses where other forms of therapy have failed
Lansoprazole	Capsule 30 mg	Gastro-oesophageal reflux disease	Oral	30	5	WY
		Scleroderma oesophagus
	Sachet containing granules for oral suspension, 30 mg per sachet	Gastro-oesophageal reflux disease Scleroderma oesophagus	Oral	28	5	WY
	Sachet containing granules for oral suspension, 30 mg per sachet	In compliance with authority procedures set out in subparagraph 11 (d): Initial treatment of peptic ulcer, in patients unable to take a solid dose form of a proton pump inhibitor	Oral	28	1	WY
	Sachet containing granules for oral suspension, 30 mg per sachet	In compliance with authority procedures set out in subparagraph 11 (d): Gastro-oesophageal reflux disease, in patients unable to take a solid dose form of a proton pump inhibitor	Oral	28	5	WY
		Scleroderma oesophagus, in patients unable to take a solid dose form of a proton pump inhibitor
Lercanidipine Hydrochloride	Tablet 10 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	30	5	SM
		Adverse effects occurring with all of the base-priced drugs
		Drug interactions occurring with all of the base-priced drugs
		Drug interactions expected to occur with all of the base-priced drugs
		Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
	Tablet 20 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	30	5	SM
		Adverse effects occurring with all of the base-priced drugs
		Drug interactions occurring with all of the base-priced drugs
		Drug interactions expected to occur with all of the base-priced drugs
		Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
Levetiracetam	Tablet 250 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	UC
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
	Tablet 500 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	UC
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
	Tablet 1 g	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	UC
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
		Treatment of partial epileptic seizures which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
Medroxyprogesterone Acetate	Tablet 10 mg	Endometriosis	Oral	100	2	KR, PH
Methadone Hydrochloride	Tablet 10 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	40	..	GK
		Severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Injection 10 mg in 1 mL ampoule	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia	Injection	10	..	GK
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Metronidazole	Tablet 400 mg	Treatment of anaerobic infections	Oral	21	1	AF, AV, HP
Morphine Hydrochloride	Oral solution 2 mg per mL, 200 mL	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia	Oral	2	..	MF
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Oral solution 5 mg per mL, 200 mL	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia	Oral	2	..	MF
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Oral solution 10 mg per mL, 200 mL	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia	Oral	2	..	MF
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Morphine Sulfate	Tablet 30 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	40	..	FM
		Severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 5 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 10 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 15 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 30 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 60 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 100 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Capsule 10 mg (containing sustained release pellets)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	GK

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Capsule 20 mg (containing sustained release pellets)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	GK

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Capsule 30 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	20	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Capsule 50 mg (containing sustained release pellets)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	GK

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Capsule 60 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	20	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Capsule 90 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	20	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Capsule 100 mg (containing sustained release pellets)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	GK

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Capsule 120 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	20	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Sachet containing controlled release granules for oral suspension, 20 mg per sachet	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months	Oral	40	..	MF

		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Sachet containing controlled release granules for oral suspension, 30 mg per sachet	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months	Oral	40	..	MF

		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Sachet containing controlled release granules for oral suspension, 60 mg per sachet	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months	Oral	40	..	MF

		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Sachet containing controlled release granules for oral suspension, 100 mg per sachet	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months	Oral	40	..	MF

		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
"Neocate"	Oral powder 400 g	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	8	5	SB
		Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
		Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
		Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
		Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
"Neocate Advance"	Oral powder 400 g	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	8	5	SB
		Continuing treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children up to the age of 2 years, where the child has been assessed by a suitably qualified allergist or paediatrician, and where the date of birth of the patient is included in the authority application
		Treatment for combined intolerance (not infant colic) to cows' milk protein, soy protein and protein hydrolysate formulae in children aged 2 years and over, where the child is assessed by a suitably qualified allergist or paediatrician at intervals not greater than 6 months, and where the date of birth of the patient is included in the authority application
		Severe intestinal malabsorption including short bowel syndrome where protein hydrolysate formulae have failed
		Severe intestinal malabsorption including short bowel syndrome where the patient has been receiving parenteral nutrition
Nifedipine	Tablet 20 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs	Oral	30	5	BN
		Drug interactions occurring with all of the base-priced drugs
		Drug interactions expected to occur with all of the base-priced drugs
		Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
Nitrazepam	Tablet 5 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	5	AF, VT
		Myoclonic epilepsy
		Malignant neoplasia (late stage)
		For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
		For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
Omeprazole	Tablet 20 mg	Gastro-oesophageal reflux disease	Oral	30	5	HX, SL
		Scleroderma oesophagus
		Zollinger-Ellison syndrome
	Capsule 20 mg	Gastro-oesophageal reflux disease	Oral	30	5	SZ
		Scleroderma oesophagus
		Zollinger-Ellison syndrome
Omeprazole Magnesium	Tablet equivalent to 20 mg omeprazole	Gastro-oesophageal reflux disease Scleroderma oesophagus	Oral	30	5	AL, AP, PM
		Zollinger-Ellison syndrome
Ondansetron	Wafer 4 mg	In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy	Oral	10	1	GK, HX, RE

	Wafer 8 mg	In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy	Oral	10	1	GK, HX, RE

Ondansetron Hydrochloride Dihydrate	Tablet equivalent to 4 mg ondansetron	In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy	Oral	10	1	AW, GK, HX, RE

	Tablet equivalent to 8 mg ondansetron	In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy	Oral	10	1	AW, GK, HX, RE

	I.V. injection equivalent to 4 mg ondansetron in 2 mL ampoule	In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy	Injection	1	..	GK, HX, RE
	I.V. injection equivalent to 8 mg ondansetron in 4 mL ampoule	In compliance with authority procedures set out in subparagraph 11 (d): Management of nausea and vomiting associated with radiotherapy being used to treat malignancy	Injection	1	..	GK, HX, RE
Oxazepam	Tablet 15 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	5	AF, SI
		Malignant neoplasia (late stage)
		For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
		For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
	Tablet 30 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	5	AF, FM, SI
		Malignant neoplasia (late stage)
		For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
		For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
Oxycodone Hydrochloride	Tablet 5 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	40	..	SI
		Severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Capsule 5 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	40	..	MF
		Severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Capsule 10 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	40	..	MF
		Severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Capsule 20 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	40	..	MF
		Severe disabling pain associated with proven malignant neoplasia
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Oral solution 5 mg per 5 mL, 250 mL	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia	Oral	2	..	MF
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 5 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 10 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 20 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 40 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
	Tablet 80 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Chronic severe disabling pain associated with proven malignant neoplasia	Oral	40	..	MF

		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Oxycodone Pectinate	Suppository equivalent to 30 mg oxycodone	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain associated with proven malignant neoplasia	Rectal	24	..	PL
		Chronic severe disabling pain not responding to non-narcotic analgesics where the total duration of narcotic analgesic treatment is less than 12 months
		Initial treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics in a patient who has been receiving narcotic analgesic treatment for this condition, where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner no earlier than 3 months prior to the date of the authority application and the clinical need for continuing narcotic analgesic treatment has been confirmed, and where the full name of the medical practitioner consulted and the date of consultation are included in the authority application
		Continuing treatment of chronic severe disabling pain not responding to non-narcotic analgesics where the patient has previously been issued with an authority prescription under the Pharmaceutical Benefits Scheme for treatment beyond 12 months of chronic severe disabling pain not responding to non-narcotic analgesics
Pantoprazole Sodium Sesquihydrate	Tablet (enteric coated), equivalent to 40 mg pantoprazole	Gastro-oesophageal reflux disease Scleroderma oesophagus Zollinger-Ellison syndrome	Oral	30	5	PH
Paracetamol	Tablet 500 mg	Chronic arthropathies	Oral	300	4	AW, CH, FM, GM, HX, JT, PC, SW, TW
Pemetrexed Disodium Heptahydrate	Powder for I.V. infusion equivalent to 500 mg pemetrexed, vial	In compliance with authority procedures set out in subparagraph 11 (d): Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with paclitaxel or docetaxel is contraindicated	Injection	2	2	LY

		Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where intolerance to treatment with either docetaxel or paclitaxel has developed
		Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where treatment with either docetaxel or paclitaxel has been unsuccessful
		Locally advanced or metastatic non-small cell lung cancer, after prior platinum-based chemotherapy, where transfer to docetaxel or paclitaxel is likely to result in adverse clinical consequences
Phenoxymethylpenicillin Potassium	Tablet equivalent to 250 mg phenoxymethylpenicillin	Prophylaxis of recurrent streptococcal infections (including rheumatic fever)	Oral	50	5	SI
	Capsule equivalent to 250 mg phenoxymethylpenicillin	Prophylaxis of recurrent streptococcal infections (including rheumatic fever)	Oral	50	5	CS, FM, GM, HX
Rabeprazole Sodium	Tablet 20 mg (enteric coated)	Gastro-oesophageal reflux disease Scleroderma oesophagus	Oral	30	5	JC
Ramipril	Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10 capsules 10 mg	In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs Drug interactions occurring with all of the base-priced drugs	Oral	1	..	AV
		Drug interactions expected to occur with all of the base-priced drugs
		Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
Ranitidine Hydrochloride	Tablet, effervescent, equivalent to 150 mg ranitidine	In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs Drug interactions occurring with all of the base-priced drugs	Oral	60	5	GK
		Drug interactions expected to occur with all of the base-priced drugs
		Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
	Syrup equivalent to 150 mg ranitidine per 10 mL, 300 mL	In compliance with authority procedures set out in subparagraph 11 (d): Adverse effects occurring with all of the base-priced drugs Drug interactions occurring with all of the base-priced drugs	Oral	2	5	GK
		Drug interactions expected to occur with all of the base-priced drugs
		Transfer to a base-priced drug would cause patient confusion resulting in problems with compliance
Rifampicin	Capsule 150 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	100	..	AF
		Leprosy in adults
	Capsule 300 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	100	..	AF
		Leprosy in adults
Risperidone	Tablet 0.5 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	JC
		Schizophrenia
	Tablet 0.5 mg (orally disintegrating)	In compliance with authority procedures set out in subparagraph 11 (d): Schizophrenia	Oral	56	5	JC
	Tablet 1 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	JC
		Schizophrenia
		Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder
	Tablet 1 mg (orally disintegrating)	In compliance with authority procedures set out in subparagraph 11 (d): Schizophrenia	Oral	56	5	JC
		Adjunctive therapy to mood stabilisers for up to 6 months, of an episode of acute mania associated with bipolar I disorder
Rituximab	Solution for I.V. infusion 100 mg in 10 mL vial	In compliance with authority procedures set out in subparagraph 11 (d): Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy	Injection	2	7	RO

		Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
	Solution for I.V. infusion 500 mg in 50 mL vial	In compliance with authority procedures set out in subparagraph 11 (d): Treatment of previously untreated, CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy	Injection	1	7	RO

		Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
"S-26 LF"	Infant formula powder 900 g	In compliance with authority procedures set out in subparagraph 11 (d): Proven chronic lactose intolerance in patients up to the age of 12 months, where the date of birth of the patient is included in the authority application, and where lactose intolerance has been proven either by the relief of symptoms on supervised withdrawal of lactose from the diet for 3 or 4 days and subsequent re-emergence of symptoms on rechallenge with lactose containing formulae or milk or food, or by the presence of not less than 0.5% reducing substance in stool exudate tested with copper sulfate diagnostic compound tablet	Oral	5	5	WY

Sertraline Hydrochloride	Tablet equivalent to 50 mg sertraline	Obsessive-compulsive disorder Panic disorder where other treatments have failed or are inappropriate	Oral	30	5	AF, AW, PF
	Tablet equivalent to 100 mg sertraline	Obsessive-compulsive disorder Panic disorder where other treatments have failed or are inappropriate	Oral	30	5	AF, AW, PF
Temazepam	Tablet 10 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	5	AF, FM, SI
		Malignant neoplasia (late stage)
		For use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
		For use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past 6 months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal
Temozolomide	Capsule 5 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	5	5	SH
		Recurrence of anaplastic astrocytoma following standard therapy
		Recurrence of glioblastoma multiforme following standard therapy
		Glioblastoma multiforme following radiotherapy
	Capsule 20 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	5	5	SH
		Recurrence of anaplastic astrocytoma following standard therapy
		Recurrence of glioblastoma multiforme following standard therapy
		Glioblastoma multiforme following radiotherapy
	Capsule 100 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	5	5	SH
		Recurrence of anaplastic astrocytoma following standard therapy
		Recurrence of glioblastoma multiforme following standard therapy
		Glioblastoma multiforme following radiotherapy
Topiramate	Tablet 25 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	JC
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
	Tablet 50 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	JC
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
	Tablet 100 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	JC
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
	Tablet 200 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	JC
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
	Capsule 15 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	JC
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid form dose of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
	Capsule 25 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	JC
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid form dose of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
	Capsule 50 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	60	5	JC
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where adverse events have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions have occurred with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where drug interactions are expected to occur with other suitable drugs available under the Pharmaceutical Benefits Scheme
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid dose form of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme would cause patient confusion resulting in problems with compliance
		Treatment of partial epileptic seizures, primary generalised tonic-clonic epileptic seizures and seizures of the Lennox-Gastaut syndrome, which are not controlled satisfactorily by other anti-epileptic drugs in patients unable to take a solid form dose of topiramate, and where transfer to another suitable drug available under the Pharmaceutical Benefits Scheme is likely to result in adverse clinical consequences
Tramadol Hydrochloride	Capsule 50 mg	For dosage titration in chronic pain where aspirin or paracetamol alone is inappropriate or has failed	Oral	20	2	AF, AW, CH, CS, GX, TW
	Tablet 50 mg (sustained release)	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics	Oral	40	..	CS
	Tablet 100 mg (sustained release)	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics	Oral	40	..	AW, CS, HX
	Tablet 150 mg (sustained release)	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics	Oral	40	..	AW, CS, HX
	Tablet 200 mg (sustained release)	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics	Oral	40	..	AW, CS, HX
	Oral drops 100 mg per mL, 10 mL	In compliance with authority procedures set out in subparagraph 11 (d): Severe disabling pain not responding to non-narcotic analgesics	Oral	2	..	CS
Valaciclovir Hydrochloride	Tablet equivalent to 500 mg valaciclovir	In compliance with authority procedures set out in subparagraph 11 (d): Episodic treatment or suppressive therapy of moderate to severe recurrent genital herpes, where the diagnosis is confirmed microbiologically (by viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction) but where commencement of treatment need not await confirmation of diagnosis	Oral	30	5	GK

	Tablet equivalent to 500 mg valaciclovir	In compliance with authority procedures set out in subparagraph 11 (d): Treatment of patients with herpes zoster within 72 hours of the onset of the rash	Oral	42	..	GK

		Herpes zoster ophthalmicus
Vancomycin Hydrochloride	Powder for injection equivalent to 500 mg (500,000 I.U.) vancomycin activity	Endophthalmitis Use initiated in a hospital for infections where vancomycin hydrochloride is an appropriate antibiotic	Injection	5	..	AS, MX

Benzydamine Hydrochloride	Mouth and throat rinse 22.5 mg per 15 mL, 500 mL	Oral application	1	..	MM
Bisacodyl	Tablet 5 mg	Oral	200	..	AE, AS
	Suppositories 10 mg, 10	Rectal	3	..	BY, PP
	Suppositories 10 mg, 12	Rectal	3	..	FL, PP
	Enemas 10 mg in 5 mL, 25	Rectal	1	..	AS
Carmellose Sodium	Mouth spray 10 mg per mL, 25 mL	Oral application	1	..	HA
	Mouth spray 10 mg per mL, 100 mL	Oral application	1	..	HA
Clonazepam	Tablet 500 micrograms	Oral	100	..	AF, RO
	Tablet 2 mg	Oral	100	..	AF, RO
	Oral liquid 2.5 mg per mL, 10 mL	Oral	2	..	RO
Diazepam	Tablet 2 mg	Oral	50	..	AF, AW, RO, SU
	Tablet 5 mg	Oral	50	..	AF, AW, GM, RO, SU
Diclofenac Sodium	Tablet 25 mg (enteric coated)	Oral	100	..	AF, AW, BG, CH, GM, GX, HX, NV, TW
	Tablet 50 mg (enteric coated)	Oral	50	..	AF, AW, CH, GM, GX, HX, NV, TW
	Suppository 100 mg	Rectal	40	..	NV
Docusate Sodium with Bisacodyl	Suppositories 100 mg-10 mg, 5	Rectal	6	..	FM
Glycerol	Suppositories 700 mg, 12	Rectal	3	..	PP
	Suppositories 1.4 g, 12	Rectal	3	..	PP
	Suppositories 2.8 g, 12	Rectal	3	..	PP
Hyoscine Butylbromide	Injection 20 mg in 1 mL ampoule	Injection	5	..	BY
Ibuprofen	Tablet 200 mg	Oral	100	..	AF
	Tablet 400 mg	Oral	90	..	AB
Indomethacin	Capsule 25 mg	Oral	100	..	AF, MK
	Suppository 100 mg	Rectal	40	..	MK
Lactulose	Solution BP 3.34 g per 5 mL, 500 mL	Oral	1	..	AF, AW, GM, GX, HX, SM
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride	Sachets containing powder for oral solution 13.125 g-350.7 mg-178.5 mg-46.6 mg, 30	Oral	1	..	NE
Methadone Hydrochloride	Oral liquid 25 mg per 5 mL, 200 mL	Oral	1	..	GK
Morphine Sulfate	Tablet 10 mg	Oral	20	..	MF
	Tablet 20 mg	Oral	20	..	MF
	Tablet 200 mg (controlled release)	Oral	20	..	MF
Naproxen	Tablet 250 mg	Oral	100	..	AF, RO
	Tablet 500 mg	Oral	50	..	AF, RO
	Tablet 750 mg (sustained release)	Oral	28	..	MD, RO
	Tablet 1 g (sustained release)	Oral	28	..	MD, RO
	Oral suspension 125 mg per 5 mL, 474 mL	Oral	1	..	RO
Naproxen Sodium	Tablet 550 mg	Oral	50	..	MD, RO
Nitrazepam	Tablet 5 mg	Oral	50	..	AF, VT
Oxazepam	Tablet 15 mg	Oral	50	..	AF, SI
	Tablet 30 mg	Oral	50	..	AF, FM, SI
Paracetamol	Tablet 665 mg (modified release)	Oral	192	..	GC, ME
	Suppositories 500 mg, 24	Rectal	1	..	GC
Promethazine Hydrochloride	Tablet 10 mg	Oral	50	..	AV
	Tablet 25 mg	Oral	50	..	AV
	Oral liquid 5 mg per 5 mL, 100 mL	Oral	1	..	AV
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate	Enemas 3.125 g-450 mg-45 mg in 5 mL, 12	Rectal	2	..	PH
Sterculia with Frangula Bark	Granules 620 mg-80 mg per g, 500 g	Oral	1	..	NE
Sulindac	Tablet 100 mg	Oral	100	..	AF
	Tablet 200 mg	Oral	50	..	AF
Temazepam	Tablet 10 mg	Oral	50	..	AF, FM, SI

Benzydamine Hydrochloride	Mouth and throat rinse 22.5 mg per 15 mL, 500 mL	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where a painful mouth is a problem	Oral application	1	3	MM
		Continuing supply for palliative care patients where a painful mouth is a problem, and where consultation with a palliative care specialist or service has occurred
Bisacodyl	Tablet 5 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	200	3	AE, AS
		Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
		Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
	Suppositories 10 mg, 10	In compliance with authority procedures set out in subparagraph 11 (d):	Rectal	3	3	BY, PP
		Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
		Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
	Suppositories 10 mg, 12	In compliance with authority procedures set out in subparagraph 11 (d):	Rectal	3	3	FL, PP
		Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
		Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
	Enemas 10 mg in 5 mL, 25	In compliance with authority procedures set out in subparagraph 11 (d):	Rectal	1	3	AS
		Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
		Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Carmellose Sodium	Mouth spray 10 mg per mL, 25 mL	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom	Oral application	1	3	HA

		Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred
	Mouth spray 10 mg per mL, 100 mL	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where dry mouth is a symptom	Oral application	1	3	HA

		Continuing supply for palliative care patients where dry mouth is a symptom, and where consultation with a palliative care specialist or service has occurred
Clonazepam	Tablet 500 micrograms	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	100	3	AF, RO
		Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy
		Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred
	Tablet 2 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	100	3	AF, RO
		Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy
		Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred
	Oral liquid 2.5 mg per mL, 10 mL	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for the prevention of epilepsy	Oral	2	3	RO

		Continuing supply for palliative care patients for the prevention of epilepsy, where consultation with a palliative care specialist or service has occurred
Diazepam	Tablet 2 mg	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem	Oral	50	3	AF, AW, RO, SU

		Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
	Tablet 5 mg	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem	Oral	50	3	AF, AW, GM, RO, SU
		Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
Diclofenac Sodium	Tablet 25 mg (enteric coated)	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred	Oral	100	3	AF, AW, BG, CH, GM, GX, HX, NV, TW

	Tablet 50 mg (enteric coated)	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred	Oral	50	3	AF, AW, CH, GM, GX, HX, NV, TW


	Suppository 100 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Rectal	40	3	NV
		Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Docusate Sodium with Bisacodyl	Suppositories 100 mg-10 mg, 5	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem	Rectal	6	3	FM

		Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Glycerol	Suppositories 700 mg, 12	In compliance with authority procedures set out in subparagraph 11 (d):	Rectal	3	3	PP
		Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
		Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
	Suppositories 1.4 g, 12	In compliance with authority procedures set out in subparagraph 11 (d):	Rectal	3	3	PP
		Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
		Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
	Suppositories 2.8 g, 12	In compliance with authority procedures set out in subparagraph 11 (d):	Rectal	3	3	PP
		Initial supply, for up to 4 months, for palliative care patients where constipation is a problem
		Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Hyoscine Butylbromide	Injection 20 mg in 1 mL ampoule	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where colicky pain is a symptom	Injection	5	3	BY

		Continuing supply for palliative care patients where colicky pain is a symptom, and where consultation with a palliative care specialist or service has occurred
Ibuprofen	Tablet 200 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	100	3	AF
		Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
	Tablet 400 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	90	3	AB
		Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Indomethacin	Capsule 25 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	100	3	AF, MK
		Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
	Suppository 100 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Rectal	40	3	MK
		Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Lactulose	Solution BP 3.34 g per 5 mL, 500 mL	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem	Oral	1	3	AF, AW, GM, GX, HX, SM
		Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Macrogol 3350 with Sodium Chloride, Sodium Bicarbonate and Potassium Chloride	Sachets containing powder for oral solution 13.125 g-350.7 mg-178.5 mg-46.6 mg, 30	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred	Oral	1	3	NE

Methadone Hydrochloride	Oral liquid 25 mg per 5 mL, 200 mL	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics	Oral	1	2	GK

		Continuing supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
Morphine Sulfate	Tablet 10 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	20	2	MF
		Initial supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics
		Continuing supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
	Tablet 20 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	20	2	MF
		Initial supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics
		Continuing supply, for up to 3 months, for palliative care patients with severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
	Tablet 200 mg (controlled release)	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics	Oral	20	2	MF

		Continuing supply, for up to 3 months, for palliative care patients with chronic severe disabling pain not responding to non-narcotic analgesics, and where consultation with a palliative care specialist or service has occurred
Naproxen	Tablet 250 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	100	3	AF, RO
		Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
	Tablet 500 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	3	AF, RO
		Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
	Tablet 750 mg (sustained release)	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem	Oral	28	3	MD, RO

		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
	Tablet 1 g (sustained release)	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem	Oral	28	3	MD, RO

		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
	Oral suspension 125 mg per 5 mL, 474 mL	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent	Oral	1	3	RO

		Continuing supply for palliative care patients where severe pain is a problem in patients unable to take a solid dose form of a non-steroidal anti-inflammatory agent, and where consultation with a palliative care specialist or service has occurred
Naproxen Sodium	Tablet 550 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	3	MD, RO
		Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Nitrazepam	Tablet 5 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	3	AF, VT
		Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem
		Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred
Oxazepam	Tablet 15 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	3	AF, SI
		Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem
		Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
	Tablet 30 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	3	AF, FM, SI
		Initial supply, for up to 4 months, for palliative care patients where anxiety is a problem
		Continuing supply for palliative care patients where anxiety is a problem, and where consultation with a palliative care specialist or service has occurred
Paracetamol	Tablet 665 mg (modified release)	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated	Oral	192	3	GC, ME

		Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where consultation with a palliative care specialist or service has occurred
	Suppositories 500 mg, 24	In compliance with authority procedures set out in subparagraph 11 (d):	Rectal	1	3	GC
		Initial supply, for up to 4 months, for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated
		Continuing supply for palliative care patients for analgesia or fever where alternative therapy cannot be tolerated, and where consultation with a palliative care specialist or service has occurred
Promethazine Hydrochloride	Tablet 10 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	3	AV
		Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem
		Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred
	Tablet 25 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	3	AV
		Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem
		Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred
	Oral liquid 5 mg per 5 mL, 100 mL	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where nausea and/or vomiting is a problem	Oral	1	3	AV

		Continuing supply for palliative care patients where nausea and/or vomiting is a problem, and where consultation with a palliative care specialist or service has occurred
Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate	Enemas 3.125 g-450 mg-45 mg in 5 mL, 12	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem	Rectal	2	3	PH

		Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Sterculia with Frangula Bark	Granules 620 mg-80 mg per g, 500 g	In compliance with authority procedures set out in subparagraph 11 (d): Initial supply, for up to 4 months, for palliative care patients where constipation is a problem	Oral	1	3	NE

		Continuing supply for palliative care patients where constipation is a problem, and where consultation with a palliative care specialist or service has occurred
Sulindac	Tablet 100 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	100	3	AF
		Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
	Tablet 200 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	3	AF
		Initial supply, for up to 4 months, for palliative care patients where severe pain is a problem
		Continuing supply for palliative care patients where severe pain is a problem, and where consultation with a palliative care specialist or service has occurred
Temazepam	Tablet 10 mg	In compliance with authority procedures set out in subparagraph 11 (d):	Oral	50	3	AF, FM, SI
		Initial supply, for up to 4 months, for palliative care patients where insomnia is a problem
		Continuing supply for palliative care patients where insomnia is a problem, and where consultation with a palliative care specialist or service has occurred

Adrenaline Acid Tartrate	Injection equivalent to adrenaline 1 in 1,000, 1 mL	Injection	5	..	AP
Amoxycillin Trihydrate	Tablet, chewable, equivalent to 250 mg amoxycillin	Oral	20	..	GK
	Capsule equivalent to 250 mg amoxycillin	Oral	20	..	AF, CH, CS, GK, GM, GX, HX, SI, TW
	Capsule equivalent to 500 mg amoxycillin	Oral	20	..	AF, CH, CS, GK, GM, GX, HX, SI, TW
	Sachet containing oral powder equivalent to 3 g amoxycillin	Oral	1	..	GK
Amoxycillin Trihydrate with Potassium Clavulanate	Tablet equivalent to 500 mg amoxycillin-125 mg clavulanic acid	Oral	10	..	AL, GK, HX, ME, SL, SZ
	Tablet equivalent to 875 mg amoxycillin-125 mg clavulanic acid	Oral	10	..	AL, CH, GK, GX, HX, ME, SL, SZ, TW
Amoxycillin Trihydrate with Potassium Clavulanate and Water - Purified BP	Powder for oral suspension equivalent to 125 mg amoxycillin-31.25 mg clavulanic acid per 5 mL, 75 mL	Oral	1	..	AL, GK, HX, ME
	Powder for oral suspension equivalent to 400 mg amoxycillin-57 mg clavulanic acid per 5 mL, 60 mL	Oral	1	..	AL, GK, HX, ME
Amoxycillin Trihydrate with Water - Purified BP	Powder for paediatric oral drops equivalent to 100 mg amoxycillin per mL, 20 mL	Oral	1	..	GK
	Powder for oral suspension equivalent to 125 mg amoxycillin per 5 mL, 100 mL	Oral	1	..	AF, CH, CS, GK, GM, GX, HX, TW
	Powder for oral suspension equivalent to 250 mg amoxycillin per 5 mL, 100 mL	Oral	1	..	AF, CH, GK, GM, GX, HX, SI, TW
	Powder for oral suspension equivalent to 500 mg amoxycillin per 5 mL, 100 mL	Oral	1	..	SZ
Amphotericin	Lozenge 10 mg	Oral	20	..	BQ
Ampicillin Sodium	Powder for injection equivalent to 500 mg ampicillin	Injection	5	..	GM, LN
	Powder for injection equivalent to 1 g ampicillin	Injection	5	..	AS, GM, LN
Ampicillin Trihydrate	Capsule equivalent to 250 mg ampicillin	Oral	24	..	AF
	Capsule equivalent to 500 mg ampicillin	Oral	24	..	AF
Aspirin	Tablet, dispersible, 300 mg	Oral	96	..	RC
Atropine Sulfate	Injection 600 micrograms in 1 mL ampoule	Injection	10	..	AP
Benzathine Penicillin	Injection 900 mg in 2 mL cartridge-needle unit (for use with Tubex Injector)	Injection	1	..	AS
	Powder for injection 900 mg	Injection	1	..	AS
Benztropine Mesylate	Injection 2 mg in 2 mL ampoule	Injection	5	..	MK
Benzydamine Hydrochloride	Mouth and throat rinse 22.5 mg per 15 mL, 500 mL	Oral application	1	..	MM
Benzylpenicillin Sodium	Powder for injection equivalent to 600 mg benzylpenicillin	Injection	10	..	CS
	Powder for injection equivalent to 3 g benzylpenicillin	Injection	10	..	CS
Betamethasone Acetate with Betamethasone Sodium Phosphate	Injection 3 mg-3.9 mg in 1 mL ampoule	Injection	5	..	SH
Carbamazepine	Tablet 100 mg	Oral	200	..	BG, NV, SZ
	Tablet 200 mg	Oral	200	..	AF, BG, NV, SZ
	Tablet 200 mg (controlled release)	Oral	200	..	NV
	Tablet 400 mg (controlled release)	Oral	200	..	NV
	Oral suspension 100 mg per 5 mL, 300 mL	Oral	1	..	NV
Cefaclor Monohydrate	Tablet (sustained release) equivalent to 375 mg cefaclor	Oral	10	..	AF, AS, CH, GM, GX, LN, RA, TW
Cefaclor Monohydrate with Water - Purified BP	Powder for oral suspension equivalent to 125 mg cefaclor per 5 mL, 100 mL	Oral	1	..	AF, AS, AW, CH, GX, TW
	Powder for oral suspension equivalent to 250 mg cefaclor per 5 mL, 75 mL	Oral	1	..	AF, AS, AW, CH, GX, TW
Cefotaxime Sodium	Powder for injection equivalent to 1 g cefotaxime	Injection	10	..	MX, SZ
	Powder for injection equivalent to 2 g cefotaxime	Injection	10	..	MX, SZ
Cefuroxime Axetil	Tablet equivalent to 250 mg cefuroxime	Oral	14	..	GK
Cephalexin	Capsule 250 mg (anhydrous)	Oral	20	..	AF, AS, CH, GM, GX, HX, LN, RA, TW
	Capsule 500 mg (anhydrous)	Oral	20	..	AF, AS, CH, GM, GX, HX, LN, RA, TW
Cephalexin with Water - Purified BP	Granules for oral suspension 125 mg per 5 mL, 100 mL	Oral	1	..	AF, AS, CH, GM, GX, LN, TW
	Granules for oral suspension 250 mg per 5 mL, 100 mL	Oral	1	..	AF, AS, CH, GM, GX, LN, TW
Cephalothin Sodium	Powder for injection equivalent to 1 g cephalothin	Injection	10	..	AS, MX
Chloramphenicol	Eye drops 5 mg per mL, 10 mL	Application to the eye	1	..	PF, SI
Clindamycin Hydrochloride	Capsule equivalent to 150 mg clindamycin	Oral	25	..	KR, PH
Codeine Phosphate	Tablet 30 mg	Oral	20	..	FM
Codeine Phosphate with Paracetamol	Tablet 30 mg-500 mg	Oral	20	..	AL, CO, DK, FM, GK, SW
Diazepam	Tablet 2 mg	Oral	50	..	AF, AW, RO, SU
	Tablet 5 mg	Oral	50	..	AF, AW, GM, RO, SU
	Injection 10 mg in 2 mL ampoule	Injection	5	..	MX
Diclofenac Sodium	Tablet 25 mg (enteric coated)	Oral	100	..	AF, AW, BG, CH, GM, GX, HX, NV, TW
	Tablet 50 mg (enteric coated)	Oral	50	..	AF, AW, CH, GM, GX, HX, NV, TW
	Suppository 100 mg	Rectal	40	..	NV
Dicloxacillin Sodium	Capsule equivalent to 250 mg dicloxacillin	Oral	24	..	AF, BQ, SI
	Capsule equivalent to 500 mg dicloxacillin	Oral	24	..	AF, BQ, SI
	Powder for injection equivalent to 500 mg dicloxacillin	Injection	5	..	BQ
	Powder for injection equivalent to 1 g dicloxacillin	Injection	5	..	BQ
Doxycycline Hydrochloride	Tablet equivalent to 100 mg doxycycline	Oral	7	..	AF, GM, PF, SI
	Capsule equivalent to 100 mg doxycycline (containing enteric coated pellets)	Oral	7	..	FA, MX
Doxycycline Monohydrate	Tablet equivalent to 100 mg doxycycline	Oral	7	..	CH, GX, SZ, TW
Erythromycin	Capsule 250 mg (containing enteric coated pellets)	Oral	25	..	FA, MX
Erythromycin Ethyl Succinate	Tablet equivalent to 400 mg erythromycin	Oral	25	..	AB, AF
Erythromycin Ethyl Succinate with Water - Purified BP	Powder for oral liquid equivalent to 200 mg erythromycin per 5 mL, 100 mL	Oral	1	..	AB, AF
	Powder for oral liquid equivalent to 400 mg erythromycin per 5 mL, 100 mL	Oral	1	..	AB, AF
Erythromycin Lactobionate	Powder for I.V. infusion equivalent to 1 g erythromycin, vial	Injection	5	..	AB
Flucloxacillin Magnesium with Water - Purified BP	Powder for oral suspension equivalent to 125 mg flucloxacillin per 5 mL, 100 mL	Oral	1	..	GK
	Powder for oral suspension equivalent to 250 mg flucloxacillin per 5 mL, 100 mL	Oral	1	..	CS, GK
Flucloxacillin Sodium	Capsule equivalent to 250 mg flucloxacillin	Oral	24	..	AF, CS, GK, SI
	Capsule equivalent to 500 mg flucloxacillin	Oral	24	..	AF, CS, GK, SI
	Powder for injection equivalent to 500 mg flucloxacillin	Injection	5	..	CS, GM
	Powder for injection equivalent to 1 g flucloxacillin	Injection	5	..	AS, CS, GM, MX
Glucagon Hydrochloride	Injection set containing 1 mg (1 I.U.) and 1 mL solvent in disposable syringe	Injection	1	..	NO
Glucose	I.V. infusion 278 mmol (anhydrous) per L, 1 L	Injection	5	..	BX
Glyceryl Trinitrate	Tablets 600 micrograms, 100	Oral	1	..	FM, SI
Hydrocortisone Acetate	Cream 10 mg per g, 30 g	Application	1	..	FM, SI
	Cream 10 mg per g, 50 g	Application	1	..	DT, FM, SI
	Ointment 10 mg per g, 30 g	Application	1	..	FM, SI
	Ointment 10 mg per g, 50 g	Application	1	..	FM, SI
Hydrocortisone Sodium Succinate	Injection equivalent to 100 mg hydrocortisone with 2 mL solvent	Injection	6	..	PH
	Injection equivalent to 250 mg hydrocortisone with 2 mL solvent	Injection	6	..	PH
Hydromorphone Hydrochloride	Tablet 2 mg	Oral	20	..	AB
	Tablet 4 mg	Oral	20	..	AB
	Tablet 8 mg	Oral	20	..	AB
	Oral liquid 1 mg per mL, 473 mL	Oral	1	..	AB
	Injection 2 mg in 1 mL ampoule	Injection	5	..	AB
	Injection 10 mg in 1 mL ampoule	Injection	5	..	AB
	Injection 50 mg in 5 mL ampoule	Injection	5	..	AB
Ibuprofen	Tablet 200 mg	Oral	100	..	AF
	Tablet 400 mg	Oral	30	..	AB
Indomethacin	Capsule 25 mg	Oral	100	..	AF, MK
	Suppository 100 mg	Rectal	40	..	MK
Ketoprofen	Capsule 200 mg (sustained release)	Oral	28	..	AV, HP
	Suppository 100 mg	Rectal	40	..	AV
Lignocaine Hydrochloride	Injection 100 mg in 5 mL	Injection	5	..	PF
Lincomycin Hydrochloride	Injection equivalent to 600 mg lincomycin in 2 mL vial	Injection	5	..	PH
Methylprednisolone Acetate	Injection 40 mg in 1 mL vial	Injection	5	..	KR, PH
Metoclopramide Hydrochloride	Tablet 10 mg	Oral	25	..	AF, VT
	Oral solution 5 mg per 5 mL, 100 mL	Oral	1	..	VT
	Injection 10 mg in 2 mL ampoule	Injection	10	..	VT
Metronidazole	Tablet 200 mg	Oral	21	..	AF, AV, HP
	Tablet 400 mg	Oral	5	..	AF
	I.V. infusion 500 mg in 100 mL	Injection	5	..	BX
	Suppositories 500 mg, 10	Rectal	1	..	AV
Metronidazole Benzoate	Oral suspension 320 mg per 5 mL, 100 mL	Oral	1	..	AV
Morphine Hydrochloride	Oral solution 2 mg per mL, 200 mL	Oral	1	..	MF
	Oral solution 5 mg per mL, 200 mL	Oral	1	..	MF
	Oral solution 10 mg per mL, 200 mL	Oral	1	..	MF
Morphine Sulfate	Tablet 30 mg	Oral	20	..	FM
	Tablet 5 mg (controlled release)	Oral	20	..	MF
	Tablet 10 mg (controlled release)	Oral	20	..	MF
	Tablet 15 mg (controlled release)	Oral	20	..	MF
	Tablet 30 mg (controlled release)	Oral	20	..	MF
	Tablet 60 mg (controlled release)	Oral	20	..	MF
	Tablet 100 mg (controlled release)	Oral	20	..	MF
	Capsule 10 mg (containing sustained release pellets)	Oral	20	..	GK
	Capsule 20 mg (containing sustained release pellets)	Oral	20	..	GK
	Capsule 30 mg (controlled release)	Oral	10	..	MF
	Capsule 50 mg (containing sustained release pellets)	Oral	20	..	GK
	Capsule 60 mg (controlled release)	Oral	10	..	MF
	Capsule 90 mg (controlled release)	Oral	10	..	MF
	Capsule 100 mg (containing sustained release pellets)	Oral	20	..	GK
	Capsule 120 mg (controlled release)	Oral	10	..	MF
	Sachet containing controlled release granules for oral suspension, 20 mg per sachet	Oral	20	..	MF
	Sachet containing controlled release granules for oral suspension, 30 mg per sachet	Oral	20	..	MF
	Sachet containing controlled release granules for oral suspension, 60 mg per sachet	Oral	20	..	MF
	Sachet containing controlled release granules for oral suspension, 100 mg per sachet	Oral	20	..	MF
	Injection 10 mg in 1 mL ampoule	Injection	5	..	MX
	Injection 15 mg in 1 mL ampoule	Injection	5	..	MX
	Injection 30 mg in 1 mL ampoule	Injection	5	..	MX
Naloxone Hydrochloride	Injection 800 micrograms in 2 mL disposable injection set	Injection	1	..	CS
	Injection 2 mg in 5 mL disposable injection set	Injection	1	..	CS
Naproxen	Tablet 250 mg	Oral	100	..	AF, RO
	Tablet 500 mg	Oral	50	..	AF, RO
	Tablet 750 mg (sustained release)	Oral	28	..	MD, RO
	Tablet 1 g (sustained release)	Oral	28	..	MD, RO
Naproxen Sodium	Tablet 550 mg	Oral	50	..	MD, RO
Nitrazepam	Tablet 5 mg	Oral	25	..	AF, VT
Nystatin	Tablet 500,000 units	Oral	50	..	SI
	Capsule 500,000 units	Oral	50	..	SI
	Oral suspension 100,000 units per mL, 24 mL	Oral	1	..	BQ, SI
Oxazepam	Tablet 15 mg	Oral	25	..	AF, SI
	Tablet 30 mg	Oral	25	..	AF, FM, SI
Oxycodone Hydrochloride	Tablet 5 mg	Oral	20	..	SI
	Capsule 5 mg	Oral	20	..	MF
	Capsule 10 mg	Oral	20	..	MF
	Capsule 20 mg	Oral	20	..	MF
	Oral solution 5 mg per 5 mL, 250 mL	Oral	1	..	MF
	Tablet 5 mg (controlled release)	Oral	20	..	MF
	Tablet 10 mg (controlled release)	Oral	20	..	MF
	Tablet 20 mg (controlled release)	Oral	20	..	MF
	Tablet 40 mg (controlled release)	Oral	20	..	MF
	Tablet 80 mg (controlled release)	Oral	20	..	MF
Oxycodone Pectinate	Suppository equivalent to 30 mg oxycodone	Rectal	12	..	PL
Paracetamol	Tablet 500 mg	Oral	100	..	AW, CH, FM, GM, HX, JT, PC, SW, TW
	Oral liquid 120 mg per 5 mL, 100 mL	Oral	1	..	SW
	Oral liquid 240 mg per 5 mL, 200 mL	Oral	1	..	SW
Pethidine Hydrochloride	Injection 100 mg in 2 mL ampoule	Injection	5	..	MX
Phenoxymethylpenicillin Benzathine	Oral suspension equivalent to 125 mg phenoxymethylpenicillin per 5 mL, 100 mL	Oral	2	..	FM, SI
	Oral suspension equivalent to 250 mg phenoxymethylpenicillin per 5 mL, 100 mL	Oral	2	..	FM, SI
Phenoxymethylpenicillin Potassium	Tablet equivalent to 250 mg phenoxymethylpenicillin	Oral	50	..	SI
	Tablet equivalent to 500 mg phenoxymethylpenicillin	Oral	50	..	SI
	Capsule equivalent to 250 mg phenoxymethylpenicillin	Oral	50	..	CS, FM, GM, HX
	Capsule equivalent to 500 mg phenoxymethylpenicillin	Oral	50	..	CS, FM, GM, HX
Piroxicam	Dispersible tablet 10 mg	Oral	50	..	AF, GX, HX, PF
	Dispersible tablet 20 mg	Oral	25	..	AF, CH, GX, HX, PF, TW
	Capsule 10 mg	Oral	50	..	AF, CH, GX, PF, TW
	Capsule 20 mg	Oral	25	..	AF, CH, GX, PF, TW
Procaine Penicillin	Injection 1.5 g in disposable syringe	Injection	5	..	SI
Prochlorperazine	Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5	Rectal	1	..	AV
	Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5	Rectal	1	..	AV
Prochlorperazine Maleate	Tablet 5 mg	Oral	25	..	AV, HP
Prochlorperazine Mesylate	Injection 12.5 mg in 1 mL ampoule	Injection	10	..	AV
Promethazine Hydrochloride	Injection 50 mg in 2 mL ampoule	Injection	10	..	MX
Sodium Chloride	Injection 9 mg per mL, 10 mL	Injection	5	..	PF
	I.V. infusion 154 mmol per L, 1 L	Injection	5	..	BX
	I.V. infusion 513 mmol per L, 1 L	Injection	2	..	BX
Sodium Chloride with Glucose	I.V. infusion 31 mmol-222 mmol (anhydrous) per L, 1 L	Injection	5	..	BX
	I.V. infusion 19 mmol-104 mmol (anhydrous) per 500 mL, 500 mL	Injection	5	..	BX
	I.V. infusion 39 mmol-69 mmol (anhydrous) per 500 mL, 500 mL	Injection	5	..	BX
Sulindac	Tablet 100 mg	Oral	100	..	AF
	Tablet 200 mg	Oral	50	..	AF
Temazepam	Tablet 10 mg	Oral	25	..	AF, FM, SI
Ticarcillin Sodium with Potassium Clavulanate with any determined brand of Sodium Chloride Injection	Powder for injection equivalent to 3 g ticarcillin-100 mg clavulanic acid (with required solvent)	Injection	10	..	GK
Tramadol Hydrochloride	Capsule 50 mg	Oral	20	..	AF, AW, CH, CS, GX, TW
	Tablet 50 mg (sustained release)	Oral	20	..	CS
	Tablet 100 mg (sustained release)	Oral	20	..	AW, CS, HX
	Tablet 150 mg (sustained release)	Oral	20	..	AW, CS, HX
	Tablet 200 mg (sustained release)	Oral	20	..	AW, CS, HX
	Oral drops 100 mg per mL, 10 mL	Oral	1	..	CS
	Injection 100 mg in 2 mL ampoule	Injection	5	..	CS, HX
Triamcinolone Acetonide	Injection 10 mg in 1 mL ampoule	Injection	5	..	BQ
Trimethoprim with Sulfamethoxazole	Tablet 80 mg-400 mg Tablet 160 mg-800 mg	Oral Oral	10 10	.. ..	AF, SI AF, CH, GX, RO, SI, TW
	Tablet 80 mg-400 mg Tablet 160 mg-800 mg	Oral Oral	10 10	.. ..	AF, SI AF, CH, GX, RO, SI, TW
	Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL	Oral	1	..	AF, RO, SI
Vancomycin Hydrochloride	Powder for injection equivalent to 500 mg (500,000 I.U.) vancomycin activity	Injection	2	..	AS, MX

Ibuprofen	Tablet 400 mg	Chronic arthropathies (including osteoarthritis) with an inflammatory component	Oral	90	..	AB
		Bone pain due to malignant disease
Metronidazole	Tablet 400 mg	Treatment of anaerobic infections	Oral	21	..	AF, AV, HP
Paracetamol	Tablet 500 mg	Chronic arthropathies	Oral	300	..	AW, CH, FM, GM, HX, JT, PC, SW, TW

Creams 100 g 1

Dusting Powders 100 g 1

Ear Drops 15 mL 2

Eye Drops containing Cocaine Hydrochloride BP 15 mL ..

Eye Drops, Other 15 mL 5

Eye Lotions 200 mL 2

Inhalations 50 mL 1

Linctuses containing Codeine Phosphate BP 100 mL ..

Linctuses, Other 100 mL 2

Lotions 200 mL 2

Mixtures containing Codeine Phosphate BP 200 mL ..

Mixtures, Other 200 mL 4

Mixtures for Children containing Codeine Phosphate BP 100 mL ..

Mixtures for Children, Other 100 mL 4

Mouth Washes 200 mL 1

Nasal Instillations 15 mL 2

Ointments and Waxes 100 g 1

Paints 25 mL 1

Pastes containing Cocaine Hydrochloride BP 25 g ..

Pastes, Other 100 g 1

Powders for Internal Use 100 g 2

Solutions 200 mL 2

Notes to the Determinations under sections 85, 85A and 88 (No. PB 47 of 2006)

Note 1

The Determinations under sections 85, 85A and 88 (No. PB 47 of 2006) (in force under sections 85, 85A and 88 of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.

Table of Instruments

Title	Date of FRLI Registration	Date of commencement	Application, saving or transitional provisions
No. PB 47 of 2006	14 Nov 2006 (see F2006L03686)	1 Dec 2006
No. PB 1 of 2007	7 Dec 2006 (see F2006L03974)	1 Jan 2007	—
No. PB 6 of 2007	11 Jan 2007 (see F2007L00082)	1 Feb 2007	—

Table of Amendments

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected	How affected
Para. 3...............	am. No. PB 6 of 2007
Para. 14..............	am. Nos. PB 1 and PB 6 of 2007
First Schedule
Part 1................	am. Nos. PB 1 and PB 6 of 2007
Part 2................	am. No. PB 6 of 2007
Third Schedule
Part 1................	am. Nos. PB 1 and PB 6 of 2007

National Health Act 1953 - Determinations under sections 85, 85A and 88 (No. PB 47 of 2006)

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