National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 9) (PB 90 of 2015) (Cth)

PB 90 of 2015

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 9)

National Health Act 1953

I, KYLIE JONASSON, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated 24 September 2015

KYLIE JONASSON
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health

1 Name of Instrument

(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 9).
(2) This Instrument may also be cited as PB 90 of 2015.

2 Commencement

This Instrument commences on 1 October 2015.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1 Amendments

Schedule 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 4;
Number of Repeats: 3]
(a)omit from the column headed “Circumstances”:               C4664
(b)omit from the column headed “Circumstances”:               C4739 C4745
(c)insert in numerical order:       C5448 C5495 C5503
(d)omit from the column headed “Purposes”:      P4664 P4745
(e)insert in numerical order:       P5448 P5495
Schedule 1, entry for Abatacept in the form Injection 125 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 4;
Number of Repeats: 5]
(a)omit from the column headed “Circumstances”:               C4664
(b)omit from the column headed “Circumstances”:               C4739 C4745
(c)insert in numerical order:       C5448 C5495 C5503
(d)omit from the column headed “Purposes”:      C4739 substitute:             P5503
Schedule 1, entry for Aciclovir in the form Eye ointment 30 mg per g, 4.5 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

AciVision

MP NP AO

C1715

Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”:               C4666
(b)omit from the column headed “Circumstances”:               C4710
(c)omit from the column headed “Circumstances”:               C4751
(d)insert in numerical order:       C5441 C5514 C5515
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”:               C4666
(b)omit from the column headed “Circumstances”:               C4710
(c)omit from the column headed “Circumstances”:               C4751
(d)insert in numerical order:       C5441 C5514 C5515
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”:               C4666
(b)omit from the column headed “Circumstances”:               C4710
(c)omit from the column headed “Circumstances”:               C4751
(d)insert in numerical order:       C5441 C5514 C5515
(e)omit from the column headed “Purposes”:      P4710 C4751
(f)insert in numerical order:     P5441 P5514
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”:               C4666
(b)omit from the column headed “Circumstances”:               C4710
(c)omit from the column headed “Circumstances”:               C4751
(d)insert in numerical order:       C5441 C5514 C5515
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”:               C4666
(b)omit from the column headed “Circumstances”:               C4710
(c)omit from the column headed “Circumstances”:               C4751
(d)insert in numerical order:       C5441 C5514 C5515
(e)omit from the column headed “Purposes”:      P4666
(f)insert in numerical order:     P5515
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”:               C4666
(b)omit from the column headed “Circumstances”:               C4710
(c)omit from the column headed “Circumstances”:               C4751
(d)insert in numerical order:       C5441 C5514 C5515
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”:               C4666
(b)omit from the column headed “Circumstances”:               C4710
(c)omit from the column headed “Circumstances”:               C4751
(d)insert in numerical order:       C5441 C5514 C5515
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”:               C4666
(b)omit from the column headed “Circumstances”:               C4710
(c)omit from the column headed “Circumstances”:               C4751
(d)insert in numerical order:       C5441 C5514 C5515
(e)omit from the column headed “Purposes”:      P4710 C4751
(f)insert in numerical order:     P5441 P5514
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”:               C4666
(b)omit from the column headed “Circumstances”:               C4710
(c)omit from the column headed “Circumstances”:               C4751
(d)insert in numerical order:       C5441 C5514 C5515
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”:               C4666
(b)omit from the column headed “Circumstances”:               C4710
(c)omit from the column headed “Circumstances”:               C4751
(d)insert in numerical order:       C5441 C5514 C5515
(e)omit from the column headed “Purposes”:      P4666
(f)insert in numerical order:     P5515
Schedule 1, entry for Aflibercept
substitute:

Aflibercept	Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL)	Injection	Eylea	BN	MP	C4153 C4154 C5453 C5467 C5468 C5521	P4153 P4154 P5467 P5521	1	2	1
MP	C4153 C4154 C5453 C5467 C5468 C5521	P5453 P5468	1	5	1

Schedule 1, entry for Alendronic Acid in the form Tablet 70 mg (as alendronate sodium)
omit from the column headed “Responsible Person” for the brand “Alendronate-GA”: GN substitute: ED
Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
(a)omit from the column headed “Responsible Person” for the brand “Alendronate D3 70 mg/70 microgram”: UA substitute: EA
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Alendronate Plus D3 Sandoz

MP NP

C4070 C4087 C4110

Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
(a)omit from the column headed “Responsible Person” for the brand “Alendronate D3 70 mg/140 microgram”: UA substitute: EA
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Alendronate Plus D3 Sandoz

MP NP

C4122 C4123 C4133

Schedule 1, entry for Alendronic acid with colecalciferol and calcium
omit from the column headed “Responsible Person” for the brand “Alendronate Plus D3 Calcium Actavis”: UA substitute: EA
Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg
omit from the column headed “Responsible Person” for the brand “Amiodarone Actavis”: GN substitute: EA
Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)
omit from the column headed “Responsible Person” for the brand “Norvapine”: GN substitute: ED
Schedule 1, entry for Amoxycillin in each of the forms: Capsule 250 mg (as trihydrate); and Capsule 500 mg (as trihydrate)
omit from the column headed “Responsible Person” for the brand “Amoxycillin-GA” (all instances): GN substitute: FM
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
omit from the column headed “Responsible Person” for the brand “GA‑Amclav 500/125” (twice occurring): GN substitute: FM
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
omit from the column headed “Responsible Person” for the brand “GA‑Amclav Forte 875/125” (twice occurring): GN substitute: FM
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL
omit from the column headed “Responsible Person” for the brand “GA-Amclav 125/31.25” (twice occurring): GN substitute: FM

Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL
omit from the column headed “Responsible Person” for the brand “GA-Amclav Forte 400/57” (twice occurring): GN substitute: FM
Schedule 1, entry for Ampicillin in each of the forms: Powder for injection 500 mg (as sodium); and Powder for injection 1 g (as sodium)
omit from the column headed “Responsible Person” for the brand “Ibimicyn” (all instances): GN substitute: EA
Schedule 1, entry for Anakinra
omit from the column headed “Circumstances”: C4920 substitute: C5450
Schedule 1, entry for Anastrozole
omit from the column headed “Circumstances” (all instances): C4795 substitute: C5464
Schedule 1, entry for Atenolol in the form Tablet 50 mg
omit from the column headed “Responsible Person” for the brand “Atenolol-GA”: GN substitute: ED
Schedule 1, entry for Atorvastatin in each of the forms: Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); Tablet 40 mg (as calcium);and Tablet 80 mg (as calcium)
omit from the column headed “Responsible Person” for the brand “Atorvachol” (all instances): GN substitute: ED
Schedule 1, entry for Azathioprine in the form Tablet 25 mg
omit:

Azran

MP NP

100

Schedule 1, entry for Azathioprine in the form Tablet 50 mg
(a)omit from the column headed “Responsible Person” for the brand “Azamun”: GN substitute: ED
(b)omit:

Azran

MP NP

100

Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate)
omit from the column headed “Responsible Person” for the brand “Azithromycin-GA” (twice occurring): UA substitute: EA
Schedule 1, entry for Bicalutamide
omit from the column headed “Responsible Person” for the brand “Bicalutamide-GA”: GN substitute: ED
Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 2.5 mg
omit from the column headed “Responsible Person” for the brand “Biso 2.5”: GN substitute: ED
Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 5 mg
omit from the column headed “Responsible Person” for the brand “Biso 5”: GN substitute: ED
Schedule 1, entry for Bisoprolol in the form Tablet containing bisoprolol fumarate 10 mg
omit from the column headed “Responsible Person” for the brand “Biso 10”: GN substitute: ED
Schedule 1, entry for Bleomycin
omit from the column headed “Responsible Person” for the brand “Bleo 15K”: GN substitute: EA
Schedule 1, entry for Bupropion
substitute:

Bupropion	Tablet containing bupropion hydrochloride 150 mg (sustained release)	Oral	Zyban	AS	MP NP	C5438 C5475 C5518	P5438 P5475	30	0	30
MP NP	C5438 C5475 C5518	P5518	90	0	90

Schedule 1, entry for Calcipotriol with betamethasone in the form Gel containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g
omit from the column headed “Circumstances”: C4506 substitute: C5465
Schedule 1, entry for Calcitriol
omit from the column headed “Responsible Person” for the brand “Calcitriol-GA”: UA substitute: ED
Schedule 1, entry for Candesartan in each of the forms: Tablet containing candesartan cilexetil 4 mg; Tablet containing candesartan cilexetil 8 mg; Tablet containing candesartan cilexetil 16 mg; and Tablet containing candesartan cilexetil 32 mg
omit from the column headed “Responsible Person” for the brand “Candesartan-GA”: GN substitute: ED
Schedule 1, entry for Candesartan with Hydrochlorothiazide in each of the forms: Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg; Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg; and Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg
omit from the column headed “Responsible Person” for the brands “Candesartan HCTZ-GA 16/12.5”, “Candesartan HCTZ-GA 32/12.5” and
“Candesartan HCTZ-GA 32/25” respectively: GN substitute: ED
Schedule 1, entry for Capecitabine in each of the forms: Tablet 150 mg; and Tablet 500 mg
omit from the column headed “Responsible Person” for the brand “Capecitabine Actavis”: GN substitute: ED
Schedule 1, entry for Carboplatin in each of the forms: Solution for I.V. injection 50 mg in 5 mL; and Solution for I.V. injection 150 mg
in 15 mL
omit from the column headed “Responsible Person” for the brand “Carbaccord”: GN substitute: EA
Schedule 1, entry for Carvedilol in each of the forms: Tablet 3.125 mg; Tablet 6.25 mg; Tablet 12.5 mg; and Tablet 25 mg
omit from the column headed “Responsible Person” for the brand “GN-Carvedilol”: GN substitute: ED
Schedule 1, entry for Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate)
omit from the column headed “Responsible Person” for the brand “Cefaclor-GA” (twice occurring): GN substitute: EA
Schedule 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium)
omit:

Ceftriaxone ICP

MP NP

C1169 C1846 C1847

Schedule 1, entry for Celecoxib in each of the forms: Capsule 100 mg; and Capsule 200 mg
omit from the column headed “Responsible Person” for the brand “Celecoxib Actavis”: GN substitute: ED
Schedule 1, entry for Cephalexin in each of the forms: Capsule 250 mg (anhydrous); and Capsule 500 mg (anhydrous)
omit from the column headed “Responsible Person” for the brand “Cilex” (all instances): GN substitute: ED
Schedule 1, entry for Certolizumab pegol
(a)omit from the column headed “Circumstances”:               C4696 C4697
(b)omit from the column headed “Circumstances”:               C4763
(c)insert in numerical order:       C5442 C5458 C5486
Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 500 mg (as hydrochloride); and Tablet 750 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Ciprofloxacin-GA” (all instances):: GN substitute: ED
Schedule 1, entry for Citalopram in the form Tablet 10 mg (as hydrobromide)
(a)omit from the column headed “Responsible Person” for the brand “Citalopram Actavis”: UA substitute: EA
(b)omit from the column headed “Responsible Person” for the brand “Citalopram-GA”: GN substitute: ED

Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
(a)omit from the column headed “Responsible Person” for the brand “Citalopram Actavis”: VN substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Citalopram-GA”: GN substitute: EF
Schedule 1, entry for Citalopram in the form Tablet 40 mg (as hydrobromide)
(a)omit from the column headed “Responsible Person” for the brand “Citalopram Actavis”: VN substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Citalopram-GA”: GN substitute: EF
Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
omit from the column headed “Responsible Person” for the brand “Clarac”: GN substitute: ED
Schedule 1, entry for Clindamycin
substitute:

Clindamycin	Capsule 150 mg (as hydrochloride)	Oral	APO-Clindamycin	TX	MP NP MW	C5470	24	0	24
PDP	C5487	24	0	24
Calindamin	QA	MP NP MW	C5470	24	0	24
PDP	C5487	24	0	24
Chem mart Clindamycin	CH	MP NP MW	C5470	24	0	24
PDP	C5487	24	0	24
Cleocin	FZ	MP NP MW	C5470	24	0	24
PDP	C5487	24	0	24
Clindamycin BNM	BZ	MP NP MW	C5470	24	0	24
PDP	C5487	24	0	24
Clindamycin-Link	LM	MP NP MW	C5470	24	0	24
PDP	C5487	24	0	24
Dalacin C	PF	MP NP MW	C5470	24	0	24
PDP	C5487	24	0	24
Terry White Chemists Clindamycin	TW	MP NP MW	C5470	24	0	24
PDP	C5487	24	0	24

Schedule 1, entry for Clobetasol
omit from the column headed “Circumstances”: C4507 substitute: C5461
Schedule 1, entry for Clopidogrel
substitute:

Clopidogrel	Tablet 75 mg	Oral	Clopidogrel-DRLA	RZ	MP NP	C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Tablet 75 mg (as besilate)	Oral	Clopidogrel Actavis	UA	MP NP	C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Clopidogrel-GA	EA	MP NP	C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Clopidogrel GH	GQ	MP NP	C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Clovix 75	QA	MP NP	C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Plidogrel	FM	MP NP	C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Tablet 75 mg (as hydrogen sulfate)	Oral	APO-Clopidogrel	TX	MP NP	C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Chem mart Clopidogrel	CH	MP NP	C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Clopidogrel AN	EA	MP NP	C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Clopidogrel RBX	RA	MP NP	C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Clopidogrel Sandoz	SZ	MP NP	C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Clopidogrel Winthrop	WA	MP NP	C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Iscover	AV	MP NP	C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Piax	AF	MP NP	C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Plavicor 75	CR	MP NP	C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Plavix	SW	MP NP	C4165 C4166 C5436 C5459 C5508 C5517 C5524 C5525	28	5	28
Terry White Chemists Clopidogrel	TW	MP NP	C5436 C5459 C5508 C5517 C5524 C5525	28	5	28

Schedule 1, entry for Clopidogrel with aspirin
substitute:

Clopidogrel with aspirin	Tablet 75 mg (as hydrogen sulfate)-100 mg	Oral	APO-Clopidogrel/ Aspirin 75/100	TX	MP NP	C5443 C5488 C5517	30	5	30
Chem mart Clopidogrel/ Aspirin 75/100	CH	MP NP	C5443 C5488 C5517	30	5	30
Clopidogrel Winthrop plus aspirin	WA	MP NP	C5443 C5488 C5517	30	5	30
Clopidogrel/ Aspirin Actavis 75/100	EA	MP NP	C5443 C5488 C5517	30	5	30
Clopidogrel/ Aspirin Sandoz 75/100	SZ	MP NP	C5443 C5488 C5517	30	5	30
CoPlavix	SW	MP NP	C5443 C5488 C5517	30	5	30
DuoCover	AV	MP NP	C5443 C5488 C5517	30	5	30
DuoPlidogrel	GZ	MP NP	C5443 C5488 C5517	30	5	30
Piax Plus Aspirin	AF	MP NP	C5443 C5488 C5517	30	5	30
Terry White Chemists Clopidogrel/ Aspirin 75/100	TW	MP NP	C5443 C5488 C5517	30	5	30

Schedule 1, entry for Cromoglycic Acid in the form Capsule containing powder for oral inhalation containing sodium cromoglycate 20 mg (for use in Intal Spinhaler or Intal Halermatic)
omit from the column headed “Responsible Person” for the brand “Intal Spincaps”: GN substitute: EA
Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 20; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances):    C1014 C1230 C1404    substitute:             C5532
(b)omit from the column headed “Purposes” (all instances):          P1230
(c)omit from the column headed “Responsible Person” for the brand “Procur”:           GN          substitute:             ED
Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg [Maximum Quantity: 100; Number of Repeats: 5]
(a)omit from the column headed “Circumstances” (all instances):    C1014 C1230 C1404
(b)omit from the column headed “Purposes” (all instances):          P1014 P1404
(c)omit from the column headed “Responsible Person” for the brand “Procur”:           GN          substitute:             ED
Schedule 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg
(a)omit from the column headed “Circumstances” (all instances): C1014 C1404
(b)omit from the column headed “Responsible Person” for the brand “Procur 100”: GN substitute: ED
Schedule 1, after entry for Dapagliflozin
insert:

Dapagliflozin with metformin	Tablet (modified release) containing 5 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride	Oral	Xigduo XR 5/1000	AP	MP NP	C5455 C5527	56	5	56
Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 500 mg metformin hydrochloride	Oral	Xigduo XR 10/500	AP	MP NP	C5455 C5527	28	5	28
Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride	Oral	Xigduo XR 10/1000	AP	MP NP	C5455 C5527	28	5	28

Schedule 1, entry for Desvenlafaxine in the form Tablet (modified release) 50 mg
omit from the column headed “Responsible Person” for the brand “Desvenlafaxine Actavis”: GN substitute: EA
Schedule 1, entry for Desvenlafaxine in the form Tablet (modified release) 100 mg
omit from the column headed “Responsible Person” for the brand “Desvenlafaxine Actavis”: GN substitute: EA
Schedule 1, entry for Diclofenac in each of the forms: Tablet (enteric coated) containing diclofenac sodium 25 mg; and Tablet (enteric coated) containing diclofenac sodium 50 mg
omit from the column headed “Responsible Person” for the brand “Diclofenac-GA” (all instances): GN substitute: ED
Schedule 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg
(a)omit from the column headed “Responsible Person” for the brand “Diltiazem Actavis”: UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Dilzem 60 mg”: GN substitute: EF
Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 140 mg in 7 mL
omit from the column headed “Responsible Person” for the brand “Oncotaxel 140”: GN substitute: EA
Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL
omit from the column headed “Responsible Person” for the brand “Oncotaxel 80”: GN substitute: EA
Schedule 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing donepezil hydrochloride 10 mg
omit from the column headed “Responsible Person” for the brand “Donepezil-GA”: GN substitute: ED
Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
omit from the column headed “Responsible Person” for the brand “Accord Doxorubicin”: GN substitute: EA
Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Doxy-50”: GN substitute: ED
Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Doxy-100” (all instances): GN substitute: ED
Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Doxycycline AN

MP NP

P4514

Schedule 1, entry for Duloxetine in each of the forms: Capsule 30 mg (as hydrochloride); and Capsule 60 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Drulox”: GN substitute: ED
Schedule 1, entry for Electrolyte Replacement, Oral
omit from the column headed “Responsible Person” for the brand “restore O.R.S.”: GN substitute: EA
Schedule 1, entry for Enalapril in each of the forms: Tablet containing enalapril maleate 5 mg; Tablet containing enalapril maleate 10 mg; and Tablet containing enalapril maleate 20 mg
omit from the column headed “Responsible Person” for the brand “Enalapril Actavis”: UA substitute: ED
Schedule 1, entry for Epirubicin in each of the forms: Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL; Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL; and Solution for injection containing epirubicin hydrochloride 200 mg
in 100 mL
omit from the column headed “Responsible Person” for the brand “Epirubicin ACT”: VN substitute: EA
Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
omit from the column headed “Responsible Person” for the brand “Escitalopram GA”: GN substitute: ED
Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate)
(a)omit:

Esomeprazole GH

MP NP

C4988 C5029 C5030 C5039

P4988

(b)omit:

Esomeprazole GH

MP NP

C4988 C5029 C5030 C5039

P5029 P5030 P5039

Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate)
(a)omit:

Esomeprazole GH

MP NP

C5011 C5021 C5028

P5028

(b)omit:

Esomeprazole GH

MP NP

C5011 C5021 C5028

P5011 P5021

Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 3]
(a)omit from the column headed “Circumstances”:               C4777 C4778 C4782
(b)insert in numerical order:       C5462 C5479 C5528
(c)omit from the column headed “Purposes”:      P4777 P4782
(d)insert in numerical order:     P5462 P5479
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 5]
(a)omit from the column headed “Circumstances”:               C4777 C4778 C4782
(b)insert in numerical order:       C5462 C5479 C5528
(c)omit from the column headed “Purposes”:      P4778
(d)insert in numerical order:     P5528
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 3]
(a)omit from the column headed “Circumstances”:               C4777 C4778 C4782
(b)insert in numerical order:       C5462 C5479 C5528
(c)omit from the column headed “Purposes”:      P4777 P4782
(d)insert in numerical order:     P5462 P5479
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 5]
(a)omit from the column headed “Circumstances”:               C4777 C4778 C4782
(b)insert in numerical order:       C5462 C5479 C5528
(c)omit from the column headed “Purposes”:      P4778
(d)insert in numerical order:     P5528
Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”:               C4777 C4778 C4782
(b)insert in numerical order:       C5462 C5479 C5528
(c)omit from the column headed “Purposes”:      P4777 P4782
(d)insert in numerical order:     P5462 P5479

Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”:               C4777 C4778 C4782
(b)insert in numerical order:       C5462 C5479 C5528
(c)omit from the column headed “Purposes”:      P4778
(d)insert in numerical order:     P5528
Schedule 1, entry for Exemestane
omit from the column headed “Responsible Person” for the brand “Exemestane-GA”: GN substitute: ED
Schedule 1, entry for Exemestane
(a)omit from the column headed “Circumstances” [Authorised Prescriber MP] (all instances):                C4802 C4808
(b)insert in numerical order:     C5522
(c)omit from the column headed “Circumstances” [Authorised Prescriber NP] (all instances): C4802 C4808    substitute:         C5522
Schedule 1, entry for Exenatide in each of the forms: Injection solution 5 micrograms per dose in pre-filled pen, 60 doses; and Injection solution 10 micrograms per dose in pre-filled pen, 60 doses
omit from the column headed “Circumstances”: C4856 C4857 substitute: C5469 C5478 C5500
Schedule 1, entry for Famciclovir in each of the forms: Tablet 125 mg; and Tablet 250 mg
omit from the column headed “Responsible Person” for the brand “Famciclovir-GA” (all instances): GN substitute: ED
Schedule 1, entry for Famciclovir in the form Tablet 500 mg [Maximum Quantity: 56; Number of Repeats: 5]
(a)omit from the column headed “Purposes” for the brands “Auro-Famciclovir 500” and “Ezovir”:       P3626 P3627 P3628 P3629
(b)omit from the column headed “Responsible Person” for the brand “Famciclovir-GA”:           GN          substitute:             ED
(c)omit from the column headed “Purposes” for the brands “Famciclovir-GA” and, “Famciclovir generichealth 500”:      P3626 P3627 P3628 P3629
(d)insert in numerical order in the column headed “Circumstances” for the brand “Famciclovir Sandoz”:            C3625
Schedule 1, entry for Famotidine in each of the forms: Tablet 20 mg; and Tablet 40 mg
omit from the column headed “Responsible Person” for the brand “Pepzan”: GN substitute: ED
Schedule 1, entry for Fentanyl in each of the forms: Lozenge 200 micrograms (as citrate); Lozenge 400 micrograms (as citrate); Lozenge 600 micrograms (as citrate); Lozenge 800 micrograms (as citrate); Lozenge 1200 micrograms (as citrate); and Lozenge 1600 micrograms
(as citrate)
omit from the column headed “Responsible Person”: OA substitute: TB

Schedule 1, entry for Fentanyl in each of the forms: Transdermal patch 2.063 mg; Transdermal patch 4.125 mg; Transdermal patch 8.25 mg; Transdermal patch 12.375 mg; and Transdermal patch 16.5 mg
omit from the column headed “Responsible Person” for the brands “Dutran 12”, “Dutran 25”, “Dutran 50”, “Dutran 75” and “Dutran 100” respectively: GN
substitute: EA
Schedule 1, entry for Filgrastim in the form Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim)
omit from the column headed “Responsible Person”: AS substitute: TB
Schedule 1, entry for Filgrastim in the form Injection 480 micrograms in 0.8 mL single use pre-filled syringe (TevaGrastim)
omit from the column headed “Responsible Person”: AS substitute: TB
Schedule 1, entry for Flucloxacillin in each of the forms: Powder for injection 500 mg (as sodium); and Powder for injection 1 g (as sodium)
omit from the column headed “Responsible Person” for the brand “Flubiclox” (all instances): GN substitute: EA
Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Fluoxetine-GA”: GN substitute: ED
Schedule 1, entry for Fluvastatin
omit:

Capsule 20 mg (as sodium)	Oral	Lescol	NV	MP	C1540 C3047	P1540	28	5	28
NP	C1540	28	5	28
Vastin	NM	MP	C1540 C3047	P1540	28	5	28
NP	C1540	28	5	28
Lescol	NV	MP	C1540 C3047	P3047	28	11	28
Vastin	NM	MP	C1540 C3047	P3047	28	11	28
Capsule 40 mg (as sodium)	Oral	Lescol	NV	MP	C1540 C3047	P1540	28	5	28
NP	C1540	28	5	28
Vastin	NM	MP	C1540 C3047	P1540	28	5	28
NP	C1540	28	5	28
Lescol	NV	MP	C1540 C3047	P3047	28	11	28
Vastin	NM	MP	C1540 C3047	P3047	28	11	28

Schedule 1, entry for Fluvoxamine in each of the forms: Tablet containing fluvoxamine maleate 50 mg; and Tablet containing fluvoxamine maleate 100 mg
omit from the column headed “Responsible Person” for the brand “Fluvoxamine GA”: GN substitute: EA
Schedule 1, entry for Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg
omit from the column headed “Responsible Person” for the brand “Fosinopril/HCT Actavis 20/12.5”: UA substitute: EA
Schedule 1, entry for Frusemide in the form Tablet 20 mg
omit from the column headed “Responsible Person” for the brand “Frusid”: GN substitute: EA
Schedule 1, entry for Frusemide in the form Tablet 40 mg
omit from the column headed “Responsible Person” for the brand “Frusid”: UA substitute: EA
Schedule 1, entry for Gabapentin in each of the forms: Capsule 300 mg; and Capsule 400 mg
omit from the column headed “Responsible Person” for the brand “Gantin”: GN substitute: EA
Schedule 1, entry for Gabapentin in the form Tablet 800 mg
omit from the column headed “Responsible Person” for the brand “Gantin”: GN substitute: ED
Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 200 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Gemaccord”: GN substitute: EA
Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 1 g (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Gemaccord”: GN substitute: EA
Schedule 1, entry for Gemcitabine in the form Powder for I.V. infusion 2 g (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Gemcitabine Actavis 2000”: GN substitute: EA
Schedule 1, entry for Gentamicin in the form Eye drops 3 mg (as sulfate) per mL, 5 mL
(a)omit from the column headed “Circumstances” [Authorised Prescriber MP]:C1188 C1391 C1714 substitute: C5451 C5483 C5499
(b)omit from the column headed “Circumstances” [Authorised Prescriber AO]: C1391 C1714 substitute: C5476 C5477
Schedule 1, entry for Glimepiride in each of the forms: Tablet 1 mg; Tablet 2 mg; Tablet 3 mg; and Tablet 4 mg
omit from the column headed “Responsible Person” for the brands “Glimepiride GA 1”, “Glimepiride GA 2”, “Glimepiride GA 3”, and “Glimepiride GA 4” respectively: GN substitute: ED

Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 3]
(a)omit from the column headed “Circumstances”:               C4702 C4744 C4754
(b)insert in numerical order:       C5457 C5463 C5513
(c)omit from the column headed “Purposes”:      P4702 P4754
(d)insert in numerical order:     P5457 P5513
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 5]
(a)omit from the column headed “Circumstances”:               C4702 C4744 C4754
(b)insert in numerical order:       C5457 C5463 C5513
(c)omit from the column headed “Purposes”:      P4744
(d)insert in numerical order:     P5463
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 3]
(a)omit from the column headed “Circumstances”:               C4702 C4744 C4754
(b)insert in numerical order:       C5457 C5463 C5513
(c)omit from the column headed “Purposes”:      P4702 P4754
(d)insert in numerical order:     P5457 P5513
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 5]
(a)omit from the column headed “Circumstances”:               C4702 C4744 C4754
(b)insert in numerical order:       C5457 C5463 C5513
(c)omit from the column headed “Purposes”:      P4744
(d)insert in numerical order:     P5463
Schedule 1, entry for Goserelin in the form Subcutaneous implant 3.6 mg (as acetate) in pre-filled injection syringe
(a)omit from the column headed “Circumstances”:           C4874
(b)omit from the column headed “Circumstances”:           C4891
(c)insert in numerical order:     C5437
Schedule 1, entry for Hydroxychloroquine
omit from the column headed “Responsible Person” for the brand “Hydroxychloroquine Actavis”: GN substitute: ED

Schedule 1, entry for Indapamide in the form Tablet containing indapamide hemihydrate 2.5 mg
omit from the column headed “Responsible Person” for the brand “Indapamide-GA”: GN substitute: ED
Schedule 1, entry for Irbesartan in the form Tablet 75 mg
(a)omit from the column headed “Responsible Person” for the brand “Irbesartan Actavis 75”: UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Irbesartan-GA”: GN substitute: EF
Schedule 1, entry for Irbesartan in the form Tablet 150 mg
(a)omit from the column headed “Responsible Person” for the brand “Irbesartan Actavis 150”: UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Irbesartan-GA”: GN substitute: EF
Schedule 1, entry for Irbesartan in the form Tablet 300 mg
(a)omit from the column headed “Responsible Person” for the brand “Irbesartan Actavis 300”: UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Irbesartan-GA”: GN substitute: EF
Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 150 mg-12.5 mg
(a)omit from the column headed “Responsible Person” for the brand “Irbesartan HCT Actavis 150/12.5”: UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Irbesartan HCTZ-GA 150/12.5”: GN substitute: EF
Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg
(a)omit from the column headed “Responsible Person” for the brand “Irbesartan HCT Actavis 300/12.5”: UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Irbesartan HCTZ-GA 300/12.5”: GN substitute: EF
Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-25 mg
(a)omit from the column headed “Responsible Person” for the brand “Irbesartan HCT Actavis 300/25”: UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Irbesartan HCTZ-GA 300/25”: GN substitute: EF
Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL; and I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL
omit from the column headed “Responsible Person” for the brand “Irinoccord”: GN substitute: EA
Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
(a)omit from the column headed “Responsible Person” for the brand “Irinotecan Actavis 500”: UA substitute: EA
(b)omit from the column headed “Responsible Person” for the brand “Tecan”: GN substitute: ED

Schedule 1, entry for Isosorbide Mononitrate in the form Tablet 60 mg (sustained release)
omit from the column headed “Responsible Person” for the brand “Imtrate 60 mg”: GN substitute: ED
Schedule 1, entry for Lamotrigine in each of the forms: Tablet 25 mg; Tablet 50 mg; Tablet 100 mg; and Tablet 200 mg
omit from the column headed “Responsible Person” for the brand “Lamotrigine-GA”: GN substitute: ED
Schedule 1, entry for Lanthanum
substitute:

Lanthanum	Tablet, chewable, 500 mg (as carbonate hydrate)	Oral	Fosrenol	ZI	MP	C5454 C5491 C5530	P5491	90	5	90
NP	C5491	90	5	90
MP	C5454 C5491 C5530	P5454 P5530	180	5	90
Tablet, chewable, 750 mg (as carbonate hydrate)	Oral	Fosrenol	ZI	MP	C5454 C5491 C5530	P5491	90	5	90
NP	C5491	90	5	90
MP	C5454 C5491 C5530	P5454 P5530	180	5	90
Tablet, chewable, 1000 mg (as carbonate hydrate)	Oral	Fosrenol	ZI	MP	C5454 C5491 C5530	P5491	90	5	90
NP	C5491	90	5	90
MP	C5454 C5491 C5530	P5454 P5530	180	5	90

Schedule 1, entry for Latanoprost
omit from the column headed “Responsible Person” for the brand “Latanoprost Actavis”: GN substitute: EA
Schedule 1, entry for Leflunomide in each of the forms: Tablet 10 mg; and Tablet 20 mg
omit from the column headed “Responsible Person” for the brand “Leflunomide-GA”: GN substitute: ED
Schedule 1, entry for Lercanidipine in each of the forms: Tablet containing lercanidipine hydrochloride 10 mg; and Tablet containing lercanidipine hydrochloride 20 mg
omit from the column headed “Responsible Person” for the brand “Lercadip”: GN substitute: EA
Schedule 1, entry for Letrozole
(a)omit from the column headed “Circumstances” (all instances): C4795 C4801 substitute: C5464
(b)omit from the column headed “Responsible Person” for the brand “Lezole”: UA substitute: ED
Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g
omit from the column headed “Responsible Person” for the brand “Kepcet”: GN substitute: ED
Schedule 1, entry for Levodopa with Carbidopa in the form Intestinal gel 20 mg-5 mg per mL, 100 mL
(a)omit from the column headed “Circumstances” [Authorised Prescriber MP]:C3703
(b)insert in numerical order: C5473
(c)omit from the column headed “Circumstances” [Authorised Prescriber NP]:C3703 substitute: C5473
Schedule 1, entry for Lisinopril in each of the forms: Tablet 5 mg; Tablet 10 mg; and Tablet 20 mg
omit from the column headed “Responsible Person” for the brand “Lisinopril-GA”: GN substitute: ED
Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30
omit from the column headed “Responsible Person” for the brand “LaxaCon” (all instances): GN substitute: EA
Schedule 1, entry for Magnesium
omit from the column headed “Circumstances” (twice occurring): C5434 C5435 substitute: C5466 C5506
Schedule 1, entry for Meloxicam in each of the forms: Tablet 7.5 mg; and Tablet 15 mg
omit from the column headed “Responsible Person” for the brand “Meloxicam-GA”: GN substitute: ED
Schedule 1, entry for Meloxicam in each of the forms: Capsule 7.5 mg; and Capsule 15 mg
omit from the column headed “Responsible Person” for the brands “Melox 7.5” and “Melox 15” respectively: GN substitute: EA
Schedule 1, entry for Metformin in each of the forms: Tablet containing metformin hydrochloride 500 mg; Tablet containing metformin hydrochloride 850 mg; and Tablet containing metformin hydrochloride 1 g
omit from the column headed “Responsible Person” for the brand “Metformin-GA”: GN substitute: ED
Schedule 1, entry for Methotrexate in each of the forms: Injection 50 mg in 2 mL vial; and Solution concentrate for I.V. infusion 1000 mg
in 10 mL vial
omit from the column headed “Responsible Person” for the brand “Methaccord” (all instances): GN substitute: EA
Schedule 1, entry for Metoclopramide in the form Tablet containing metoclopramide hydrochloride 10 mg
omit from the column headed “Responsible Person” for the brand “Metoclopramide Actavis”: GN substitute: ED
Schedule 1, entry for Metoprolol in each of the forms: Tablet containing metoprolol tartrate 50 mg; and Tablet containing metoprolol tartrate 100 mg
omit from the column headed “Responsible Person” for the brand “Metoprolol Actavis”: GN substitute: ED
Schedule 1, entry for Milk powder—lactose free formula in the form Oral powder 900 g (Karicare Aptamil Gold De-Lact)
(a)omit from the column headed “Form”: (Karicare Aptamil Gold De-Lact) substitute: (Aptamil Gold+ De-Lact)
(b)omit from the column headed “Brand”: Karicare Aptamil Gold De-Lact substitute: Aptamil Gold+ De-Lact
Schedule 1, entry for Mirtazapine in each of the forms: Tablet 30 mg; and Tablet 45 mg
omit from the column headed “Responsible Person” for the brand “Mirtazapine-GA”: GN substitute: ED
Schedule 1, entry for Moclobemide in each of the forms: Tablet 150 mg; and Tablet 300 mg
omit from the column headed “Responsible Person” for the brand “Clobemix”: GN substitute: ED
Schedule 1, entry for Modafinil
omit from the column headed “Responsible Person”: CS substitute: TB
Schedule 1, entry for Montelukast in each of the forms: Tablet, chewable, 4 mg (as sodium); and Tablet, chewable, 5 mg (as sodium)
omit from the column headed “Responsible Person” for the brands “Montair 4” and “Montair 5” respectively: GN substitute: ED
Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 100 mg (controlled release)
omit from the column headed “Brand”: APOTEX-MORPHINE MR substitute: MORPHINE MR APOTEX
Schedule 1, entry for Nevirapine in the form Tablet 200 mg
omit from the column headed “Responsible Person” for the brand “Nevipin”: GN substitute: EA
Schedule 1, entry for Olanzapine in each of the forms: Tablet 2.5 mg; Tablet 5 mg; Tablet 7.5 mg; and Tablet 10 mg
omit from the column headed “Responsible Person” for the brand “Olanzapine-GA”: GN substitute: ED
Schedule 1, entry for Olanzapine in each of the forms: Tablet 5 mg (orally disintegrating); and Tablet 10 mg (orally disintegrating)
omit from the column headed “Responsible Person” for the brand “Olanzapine-GA ODT”: GN substitute: ED
Schedule 1, entry for Omeprazole in the form Tablet 20 mg
omit from the column headed “Responsible Person” for the brand “Omeprazole-GA” (twice occurring): GN substitute: ED
Schedule 1, entry for Omeprazole in the form Capsule 20 mg
omit from the column headed “Responsible Person” for the brand “Omepro-GA” (twice occurring): GN substitute: EA
Schedule 1, entry for Ondansetron in each of the forms: Tablet (orally disintegrating) 4 mg; and Tablet (orally disintegrating) 8 mg
omit from the column headed “Responsible Person” for the brands “Onsetron ODT 4” and “Onsetron ODT 8” (all instances): GN substitute: ED
Schedule 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
omit from the column headed “Responsible Person” for the brand “Oxaliccord”: GN substitute: EA
Schedule 1, entry for Oxycodone
omit:

Tablet containing oxycodone hydrochloride 5 mg	Oral	Endone	QA	MP NP PDP	C4926 C4959	20	0	20
Oxycodone Aspen	FM	MP NP PDP	C4926 C4959	20	0	20
Capsule containing oxycodone hydrochloride 5 mg	Oral	OxyNorm	MF	MP NP PDP	C4926 C4959	20	0	20
Capsule containing oxycodone hydrochloride 10 mg	Oral	OxyNorm	MF	MP NP PDP	C4926 C4959	20	0	20
Capsule containing oxycodone hydrochloride 20 mg	Oral	OxyNorm	MF	MP NP	C4959	20	0	20
Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL	Oral	OxyNorm Liquid 5mg/5mL	MF	MP NP PDP	C4926 C4959	1	0	1

substitute:

Tablet containing oxycodone hydrochloride 5 mg	Oral	Endone	QA	MP NP	C4959	20	0	20
PDP	C4926	20	0	20
Mayne Pharma Oxycodone IR	YN	MP NP	C4959	20	0	20
PDP	C4926	20	0	20
Oxycodone Aspen	FM	MP NP	C4959	20	0	20
PDP	C4926	20	0	20
Capsule containing oxycodone hydrochloride 5 mg	Oral	OxyNorm	MF	MP NP	C4959	20	0	20
PDP	C4926	20	0	20
Capsule containing oxycodone hydrochloride 10 mg	Oral	OxyNorm	MF	MP NP	C4959	20	0	20
PDP	C4926	20	0	20
Capsule containing oxycodone hydrochloride 20 mg	Oral	OxyNorm	MF	MP NP	C4959	20	0	20
Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL	Oral	OxyNorm Liquid 5mg/5mL	MF	MP NP	C4959	1	0	1
PDP	C4926	1	0	1

Schedule 1, entry for Oxycodone
omit:

Suppository 30 mg (as pectinate)

Rectal

Proladone

MP NP PDP

C4926 C4959

substitute:

Suppository 30 mg (as pectinate)	Rectal	Proladone	PL	MP NP	C4959	12	0	12
PDP	C4926	12	0	12

Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 30 mg in 5 mL
(a)omit from the column headed “Responsible Person” for the brand “Paclitaxel Actavis”: UA substitute: EA
(b)omit from the column headed “Responsible Person” for the brand “Plaxel”: GN substitute: ED
Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL
(a)omit from the column headed “Responsible Person” for the brand “Paclitaxel Actavis”: UA substitute: EA
(b)omit from the column headed “Responsible Person” for the brand “Plaxel”: GN substitute: ED
Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 150 mg in 25 mL
(a)omit from the column headed “Responsible Person” for the brand “Paclitaxel Actavis”: UA substitute: EA
(b)omit from the column headed “Responsible Person” for the brand “Plaxel”: GN substitute: ED
Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 300 mg in 50 mL
(a)omit from the column headed “Responsible Person” for the brand “Paclitaxel Actavis”: UA substitute: EA
(b)omit from the column headed “Responsible Person” for the brand “Plaxel”: GN substitute: ED

Schedule 1, entry for Panitumumab in each of the forms: Solution concentrate for I.V. infusion 100 mg in 5 mL; and Solution concentrate for I.V. infusion 400 mg in 20 mL
(a)omit from the column headed “Circumstances”: C4783 C4784 substitute: C5439 C5447 C5452 C5526
(b)omit from the column headed “Purposes”: See Note 3
Schedule 1, entry for Pantoprazole
substitute:

Pantoprazole	Sachet containing granules 40 mg (as sodium sesquihydrate)	Oral	Somac	NQ	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Tablet (enteric coated) 20 mg (as sodium sesquihydrate)	Oral	APO-Pantoprazole	TX	MP NP	C5444 C5512 C5529	30	5	30
APOTEX-Pantoprazole	GX	MP NP	C5444 C5512 C5529	30	5	30
Chem mart Pantoprazole	CH	MP NP	C5444 C5512 C5529	30	5	30
I-Pantoprazole	CR	MP NP	C5444 C5512 C5529	30	5	30
Ozpan	RA	MP NP	C5444 C5512 C5529	30	5	30
Panthron	ER	MP NP	C5444 C5512 C5529	30	5	30
Panto	TK	MP NP	C5444 C5512 C5529	30	5	30
Pantofast 20	RZ	MP NP	C5444 C5512 C5529	30	5	30
Pantoprazole AN	EA	MP NP	C5444 C5512 C5529	30	5	30
Pantoprazole Sandoz	SZ	MP NP	C5444 C5512 C5529	30	5	30
Pantoprazole generichealth	GQ	MP NP	C5444 C5512 C5529	30	5	30
Pantoprazole-GA	EF	MP NP	C5444 C5512 C5529	30	5	30
Salpraz	AF	MP NP	C5444 C5512 C5529	30	5	30
Somac	NQ	MP NP	C5444 C5512 C5529	30	5	30
Sozol	QA	MP NP	C5444 C5512 C5529	30	5	30
Terry White Chemists Pantoprazole	TW	MP NP	C5444 C5512 C5529	30	5	30
Torzole 20	VN	MP NP	C5444 C5512 C5529	30	5	30
Tablet (enteric coated) 40 mg (as sodium sesquihydrate)	Oral	APO-Pantoprazole	TX	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
APOTEX-Pantoprazole	GX	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Chem mart Pantoprazole	CH	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
I-Pantoprazole	CR	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Ozpan	RA	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Panthron	ER	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Panto	TK	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Pantofast 40	RZ	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Pantoprazole AN	EA	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Pantoprazole Actavis	ED	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Pantoprazole Sandoz	SZ	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Pantoprazole generichealth	GQ	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Pantoprazole-GA	EF	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Salpraz	AF	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Somac	NQ	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Sozol	QA	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Terry White Chemists Pantoprazole	TW	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Topra 40	DO	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
Torzole 40	VN	MP NP	C5444 C5445 C5512 C5529	P5445	30	2	30
APO-Pantoprazole	TX	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
APOTEX-Pantoprazole	GX	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Chem mart Pantoprazole	CH	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
I-Pantoprazole	CR	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Ozpan	RA	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Panthron	ER	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Panto	TK	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Pantofast 40	RZ	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Pantoprazole AN	EA	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Pantoprazole Actavis	ED	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Pantoprazole Sandoz	SZ	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Pantoprazole generichealth	GQ	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Pantoprazole-GA	EF	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Salpraz	AF	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Somac	NQ	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Sozol	QA	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Terry White Chemists Pantoprazole	TW	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Topra 40	DO	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30
Torzole 40	VN	MP NP	C5444 C5445 C5512 C5529	P5444 P5512 P5529	30	5	30

Schedule 1, entry for Paracetamol in the form Tablet 500 mg
omit from the column headed “Responsible Person” for the brand “Febridol” (all instances): GN substitute: EA
Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)
(a)omit from the column headed “Responsible Person” for the brand “Paroxetine Actavis”: UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Paroxetine-GA”: GN substitute: FM
Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
omit from the column headed “Responsible Person” for the brand “Perindopril Actavis 2”: UA substitute: EA
Schedule 1, entry for Perindopril in each of the forms: Tablet containing perindopril erbumine 4 mg; and Tablet containing perindopril erbumine 8 mg
omit from the column headed “Responsible Person” for the brands “Perindopril Actavis 4” and “Perindopril Actavis 8” respectively: UA
substitute: ED
Schedule 1, entry for Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
omit from the column headed “Responsible Person” for the brand “Perindopril Combi Actavis 4/1.25”: GN substitute: ED
Schedule 1, entry for Pimecrolimus
omit from the column headed “Circumstances”: C2455 C2456 substitute: C5472 C5482
Schedule 1, entry for Pioglitazone in each of the forms: Tablet 15 mg (as hydrochloride); Tablet 30 mg (as hydrochloride); and
Tablet 45 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Pioglitazone-GA”: GN substitute: ED
Schedule 1, entry for Pravastatin in each of the forms: Tablet containing pravastatin sodium 10 mg; Tablet containing pravastatin sodium 20 mg; Tablet containing pravastatin sodium 40 mg; and Tablet containing pravastatin sodium 80 mg
omit from the column headed “Responsible Person” for the brands “Pravastatin-GA 10”, “Pravastatin-GA 20”, “Pravastatin-GA 40” and “Pravastatin-GA 80” respectively (all instances): GN substitute: ED
Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg
omit from the column headed “Responsible Person” for the brand “Prochlorperazine‑GA”: GN substitute: ED
Schedule 1, entry for Protein hydrolysate formula with medium chain triglycerides
(a)omit from the column headed “Form”: (Karicare Aptamil Pepti-Junior Gold) substitute: (Aptamil Gold+ Pepti-Junior)
(b)omit from the column headed “Brand”: Karicare Aptamil Pepti-Junior Gold substitute: Aptamil Gold+ Pepti-Junior
Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
(a)omit from the column headed “Responsible Person” for the brand “Quetiaccord”: UA substitute: EF
(b)omit from the column headed “Responsible Person” for the brand “Quetiapine Actavis 25”: VN substitute: ED
Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
(a)omit from the column headed “Responsible Person” for the brand “Quetiaccord”: UA substitute: EF
(b)omit from the column headed “Responsible Person” for the brand “Quetiapine Actavis 100”: VN substitute: ED
Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
(a)omit from the column headed “Responsible Person” for the brand “Quetiaccord”: UA substitute: EF
(b)omit from the column headed “Responsible Person” for the brand “Quetiapine Actavis 200”: VN substitute: ED

Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
(a)omit from the column headed “Responsible Person” for the brand “Quetiaccord”: UA substitute: EF
(b)omit from the column headed “Responsible Person” for the brand “Quetiapine Actavis 300”: VN substitute: ED
Schedule 1, entry for Quinapril in each of the forms: Tablet 5 mg (as hydrochloride); Tablet 10 mg (as hydrochloride); and Tablet 20 mg
(as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Aquinafil”: GN substitute: EA
Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated)
omit from the column headed “Responsible Person” for the brand “Rabeprazole Actavis 20” (twice occurring): UA substitute: ED
Schedule 1, entry for Ramipril in the form Capsule 2.5 mg
omit from the column headed “Responsible Person” for the brand “Ramipril-GA”: GN substitute: EA
Schedule 1, entry for Ramipril in the form Capsule 5 mg
omit from the column headed “Responsible Person” for the brand “Ramipril-GA”: GN substitute: EA
Schedule 1, entry for Ramipril in the form Capsule 10 mg
omit from the column headed “Responsible Person” for the brand “Ramipril-GA”: GN substitute: ED
Schedule 1, entry for Ranitidine in each of the forms: Tablet 150 mg (as hydrochloride); and Tablet 300 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Ranoxyl”: GN substitute: FM
Schedule 1, entry for Riluzole
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Riluzole Winthrop

MP NP

C5341 C5365

Schedule 1, entry for Risperidone in the form Tablet 0.5 mg
(a)omit from the column headed “Responsible Person” for the brand “Risperidone Actavis 0.5” (twice occurring): UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Risperidone-GA” (twice occurring): GN substitute: EF
Schedule 1, entry for Risperidone in the form Tablet 1 mg
(a)omit from the column headed “Responsible Person” for the brand “Risperidone Actavis 1” (twice occurring): UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Risperidone-GA” (twice occurring): GN substitute: EF

Schedule 1, entry for Risperidone in the form Tablet 2 mg
(a)omit from the column headed “Responsible Person” for the brand “Risperidone Actavis 2” (twice occurring): UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Risperidone-GA” (twice occurring): GN substitute: EF
Schedule 1, entry for Risperidone in the form Tablet 3 mg
(a)omit from the column headed “Responsible Person” for the brand “Risperidone Actavis 3”: UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Risperidone-GA”: GN substitute: EF
Schedule 1, entry for Risperidone in the form Tablet 4 mg
omit from the column headed “Responsible Person” for the brand “Risperidone-GA”: GN substitute: EF
Schedule 1, entry for Rosuvastatin in each of the forms: Tablet 5 mg (as calcium); Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); and Tablet 40 mg (as calcium)
omit from the column headed “Responsible Person” for the brands “Rosuvastatin Actavis 5”, “Rosuvastatin Actavis 10”, “Rosuvastatin Actavis 20” and “Rosuvastatin Actavis 40” respectively (all instances): GN substitute: ED
Schedule 1, entry for Roxithromycin in each of the forms: Tablet 150 mg; and Tablet 300 mg
omit from the column headed “Responsible Person” for the brand “Roxithromycin-GA” (all instances): GN substitute: ED
Schedule 1, entry for Salbutamol in each of the forms: Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30; and Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30
omit from the column headed “Responsible Person” for the brand “Salbutamol Actavis”: UA substitute: EA
Schedule 1, entry for Sertraline in the form Tablet 50 mg (as hydrochloride)
(a)omit from the column headed “Responsible Person” for the brand “Sertraline Actavis”: UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Xydep 50”: GN substitute: EF
Schedule 1, entry for Sertraline in the form Tablet 100 mg (as hydrochloride)
(a)omit from the column headed “Responsible Person” for the brand “Sertraline Actavis”: UA substitute: ED
(b)omit from the column headed “Responsible Person” for the brand “Xydep 100”: GN substitute: EF
Schedule 1, entry for Sevelamer
substitute:

Sevelamer	Tablet containing sevelamer hydrochloride 800 mg	Oral	Renagel	GZ	MP	C5454 C5491 C5530	P5491	180	5	180
NP	C5491	180	5	180
MP	C5454 C5491 C5530	P5454 P5530	360	5	180

Schedule 1, entry for Simvastatin in each of the forms: Tablet 10 mg; Tablet 20 mg; Tablet 40 mg; and Tablet 80 mg
omit from the column headed “Responsible Person” for the brands “Simvastatin-GA 10”, “Simvastatin-GA 20”, “Simvastatin-GA 40” and “Simvastatin-GA 80” respectively (all instances): GN substitute: ED
Schedule 1, entry for Sucroferric oxyhydroxide
substitute:

Sucroferric oxyhydroxide	Tablet, chewable, 2.5 g (equivalent to 500 mg iron)	Oral	Velphoro	FN	MP	C5454 C5491 C5530	P5491	90	5	90
NP	C5491	90	5	90
MP	C5454 C5491 C5530	P5454 P5530	180	5	90

Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)
omit from the column headed “Responsible Person” for the brand “Sumatriptan-GA”: GN substitute: ED
Schedule 1, entry for Tamoxifen in the form Tablet 20 mg (as citrate)
omit from the column headed “Responsible Person” for the brand “Tamoxen 20 mg”: GN substitute: EA
Schedule 1, entry for Telmisartan in each of the forms: Tablet 40 mg; and Tablet 80 mg
omit from the column headed “Responsible Person” for the brand “Telmigen”: GN substitute: ED
Schedule 1, entry for Telmisartan with Hydrochlorothiazide in each of the forms: Tablet 40 mg-12.5 mg; Tablet 80 mg-12.5 mg; and
Tablet 80 mg-25 mg
omit from the column headed “Responsible Person” for the brands “Telmigen HCT 40/12.5”, “Telmigen HCT 80/12.5” and “Telmigen HCT 80/25” respectively: GN substitute: ED
Schedule 1, entry for Temozolomide in each of the forms: Capsule 5 mg; Capsule 20 mg; Capsule 100 mg; and Capsule 140 mg
omit from the column headed “Responsible Person” for the brand “Astromide” (all instances): GN substitute: ED

Schedule 1, entry for Temozolomide in the form Capsule 180 mg
omit from the column headed “Responsible Person” for the brand “Astromide” (twice occurring): GN substitute: EA
Schedule 1, entry for Temozolomide in the form Capsule 250 mg
omit from the column headed “Responsible Person” for the brand “Astromide”: GN substitute: ED
Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Terbinafine Actavis”: VN substitute: ED
Schedule 1, entry for Testosterone in each of the forms: Capsule containing testosterone undecanoate 40 mg; Injection containing testosterone enanthate 250 mg in 1 mL; I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL; Transdermal cream 50 mg
per mL, 50 mL, Transdermal gel 50 mg in 5 g sachet, 30; Transdermal gel (pump pack) 12.5 mg per 1.25 g dose, 60 doses, 2; Transdermal patches 12.2 mg, 60; Transdermal patches 24.3 mg, 30; and Transdermal solution (pump pack) 30 mg per 1.5 mL dose, 60 doses
omit from the column headed “Circumstances”: C4866 C4867 C4868 C4869 C4870 substitute: C5449 C5460 C5471 C5474 C5511
Schedule 1, after entry for Tiotropium in the form Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)
insert in the columns in the order indicated:

Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 doses)

Inhalation by mouth

Spiriva Respimat

C5509

Schedule 1, entry for Tobramycin in each of the forms: Injection 80 mg (as sulfate) in 2 mL; and Injection 80 mg (as sulfate) in 2 mL (without preservative)
omit from the column headed “Circumstances”: C1169 C1846 C1847 substitute: C5446 C5490 C5519
Schedule 1, entry for Tobramycin in the form Injection 500 mg (as sulfate) in 5 mL (without preservative)
omit from the column headed “Circumstances”: C3190 substitute: C5498
Schedule 1, entry for Tobramycin in the form Solution for inhalation 300 mg in 5 mL
omit from the column headed “Circumstances”: C3842 substitute: C5520
Schedule 1, entry for Tobramycin in each of the forms: Eye drops 3 mg per mL, 5 mL; and Eye ointment 3 mg per g, 3.5 g
(a)omit from the column headed “Circumstances” [Authorised Prescriber MP]:C1188 C1391 C1714 substitute: C5451 C5483 C5499
(b)omit from the column headed “Circumstances” [Authorised Prescriber AO]: C1391 C1714 substitute: C5476 C5477
Schedule 1, after entry for Tocilizumab in the form Concentrate for injection 400 mg in 20 mL
insert:

Tofacitinib	Tablet 5 mg	Oral	Xeljanz	PF	MP	C5480 C5496 C5504 C5510	P5480 P5496 P5510	56	3	56
MP	C5480 C5496 C5504 C5510	P5504	56	5	56

Schedule 1, entry for Topiramate in each of the forms: Tablet 25 mg; and Tablet 50 mg
(a)omit from the column headed “Circumstances” (all instances): C5290
(b)insert in numerical order: C5516
Schedule 1, entry for Topiramate in each of the forms: Tablet 100 mg; and Tablet 200 mg
omit from the column headed “Circumstances” (all instances): C5290 substitute: C5516
Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg
omit from the column headed “Responsible Person” for the brand “Tramadol Actavis”: UA substitute: ED
Schedule 1, entry for Tramadol in each of the forms: Tablet (sustained release) containing tramadol hydrochloride 100 mg; Tablet (sustained release) containing tramadol hydrochloride 150 mg; and Tablet (sustained release) containing tramadol hydrochloride 200 mg
omit from the column headed “Responsible Person” for the brands “GA Tramadol SR 100mg”, “GA Tramadol SR 150mg” and “GA Tramadol SR 200mg” respectively: GN substitute: ED
Schedule 1, entry for Tramadol in the form Injection containing tramadol hydrochloride 100 mg in 2 mL
omit from the column headed “Responsible Person” for the brand “Tramadol ACT”: GN substitute: EA
Schedule 1, entry for Valaciclovir
omit from the column headed “Responsible Person” for the brand “Valaciclovir Actavis” (all instances): VN substitute: ED
Schedule 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Vycin IV” (twice occurring): GN substitute: EA
Schedule 1, entry for Venlafaxine in each of the forms: Capsule (modified release) 37.5 mg (as hydrochloride); Capsule (modified release) 75 mg (as hydrochloride); and Capsule (modified release) 150 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Venlafaxine Actavis XR”: UA substitute: ED

Schedule 1, entry for Zolmitriptan
omit from the column headed “Circumstances” (all instances): C4573 substitute: C5489
Schedule 2, Part 1, entry for Aqueous Cream APF
insert in the column headed “Circumstances”: For use only as a base combined with active ingredients
Schedule 2, Part 1, entry for Ascorbic Acid BP
insert in the column headed “Circumstances”: For use only as an ingredient of ferrous sulfate mixtures
Schedule 2, Part 1, entry for Cetomacrogol Cream, Aqueous APF
insert in the column headed “Circumstances”: For use only as a base combined with active ingredients
Schedule 2, Part 1, entry for Cetrimide Cream, Aqueous APF
insert in the column headed “Circumstances”: For use only as a base combined with active ingredients
Schedule 2, Part 1, entry for Chlorhexidine Cream, Aqueous APF
insert in the column headed “Circumstances”: For use only as a base combined with active ingredients
Schedule 2, Part 1, entry for Codeine Phosphate BP
insert in the column headed “Circumstances”: May only be prescribed in linctuses, mixtures and mixtures for children
Schedule 2, Part 1, entry for Emulsifying Ointment BP
insert in the column headed “Circumstances”: For use only as a base combined with active ingredients
Schedule 2, Part 1, entry for Ephedrine Hydrochloride BP
insert in the column headed “Circumstances”: May only be prescribed in nasal instillations
Schedule 2, Part 1, entry for Magnesium Sulfate BP
insert in the column headed “Circumstances”: May only be prescribed for other than oral use
Schedule 2, Part 1, entry for Paraffin, Liquid BP
insert in the column headed “Circumstances”: May only be prescribed for other than oral use
Schedule 2, Part 1, entry for Phenobarbitone Sodium BP
insert in the column headed “Circumstances”: May only be prescribed for the treatment of epilepsy

Schedule 2, Part 1, entry for Phenol, Liquefied BP
insert in the column headed “Circumstances”: Not available for ear drops
Schedule 2, Part 1, entry for Simple Ointment (white) BP
insert in the column headed “Circumstances”: For use only as a base combined with active ingredients
Schedule 2, Part 1, entry for Simple Ointment (yellow) BP
insert in the column headed “Circumstances”: For use only as a base combined with active ingredients
Schedule 2, Part 1, entry for Water For Injections, sterilised BP
insert in the column headed “Circumstances”: May only be prescribed in eye drops and eye lotions
Schedule 2, Part 1, entry for Wool Alcohols Ointment (white) BP
insert in the column headed “Circumstances”: For use only as a base combined with active ingredients
Schedule 2, Part 1, entry for Wool Alcohols Ointment (yellow) BP
insert in the column headed “Circumstances”: For use only as a base combined with active ingredients
Schedule 2, Part 1, entry for Zinc Cream BP
insert in the column headed “Circumstances”: For use only as a base combined with active ingredients
Schedule 3, after details relevant to Responsible Person code DV
insert:

Medsurge Healthcare Pty Ltd

92 124 728 892

Schedule 3, after details relevant to Responsible Person code EA
insert:

ED	Amneal Pharmaceuticals Pty Ltd	11 163 167 851
EF	Amneal Pharmaceuticals Pty Ltd	11 163 167 851

Schedule 4, Part 1, entry for Abatacept
(a)omit:

C4664

P4664

Severe active rheumatoid arthritis

Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)

Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly

Patient must be aged 18 years or older

Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis

For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab

If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable

The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances

The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs

If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application

The authority application must be made in writing and must include:
(1) completed authority prescription forms; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement

Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the pre-filled syringes, with a maximum quantity of 4 and up to 3 repeats

Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats

Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment

Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug

Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below

Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased

Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition

The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
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) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/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)

The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application

If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied

Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response

Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Pantoprazole
substitute:

Pantoprazole	C5444	P5444	Gastro-oesophageal reflux disease
C5445	P5445	Peptic ulcer Initial treatment
C5512	P5512	Scleroderma oesophagus
C5529	P5529	Zollinger-Ellison syndrome

Schedule 4, Part 1, entry for Pimecrolimus
substitute:

Pimecrolimus

C5472

Atopic dermatitis

Short-term (up to 3 weeks) intermittent treatment

The condition must be on the patient's face; OR
The condition must be on the patient's eyelid; AND
Patient must have failed to achieve satisfactory disease control with intermittent topical corticosteroid therapy; AND
The condition must have been initially diagnosed more than three months prior to this treatment; AND
Patient must not receive more than two 15 g packs of PBS-subsidised pimecrolimus per 6-month period.
Patient must be at least 3 months of age.
Failure to achieve satisfactory disease control with intermittent topical corticosteroid therapy is manifest by:
(i) failure of the facial skin to clear despite at least 2 weeks of topical hydrocortisone 1% applied every day; or
(ii) failure of the facial skin to clear despite at least 1 week of a moderate or potent topical corticosteroid applied every day; or
(iii) clearing of the facial skin with at least 2 weeks of topical hydrocortisone 1% applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions; or
(iv) clearing of the facial skin with at least 1 week of a moderate or potent topical corticosteroid applied every day, but almost immediate and significant flare in facial disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions.

Compliance with Authority Required procedures - Streamlined Authority Code 5472

C5482

Atopic dermatitis

The condition must be on the patient's face; OR
The condition must be on the patient's eyelid; AND
Patient must have 1 or more of the following contraindications to topical corticosteroids: (i) perioral dermatitis; (ii) periorbital dermatitis; (iii) rosacea; (iv) epidermal atrophy; (v) dermal atrophy; (vi) allergy to topical corticosteroids; (vii) cataracts; (viii) glaucoma; (ix) raised intraocular pressure; AND
Patient must not receive more than two 15 g packs of PBS-subsidised pimecrolimus per 6-month period.
Patient must be at least 3 months of age.

Compliance with Authority Required procedures - Streamlined Authority Code 5482

Schedule 4, Part 1, entry for Ranibizumab [Circumstances Code C5054]
omit from the column headed “Circumstances and Purposes”:
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 39 letters
substitute:
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters
Schedule 4, Part 1, entry for Sevelamer
substitute:

Sevelamer

C5454

P5454

Where the patient is receiving treatment at/from a private hospital

Hyperphosphataemia

Initiation and stabilization

The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non-calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.

Compliance with Written or Telephone Authority Required procedures

C5491

P5491

Hyperphosphataemia

Maintenance following initiation and stabilization

Compliance with Authority Required procedures - Streamlined Authority Code 5491

C5530

P5530

Where the patient is receiving treatment at/from a public hospital

Hyperphosphataemia

Initiation and stabilization

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5530

Schedule 4, Part 1, entry for Sucroferric oxyhydroxide
substitute:

Sucroferric oxyhydroxide

C5454

Where the patient is receiving treatment at/from a private hospital

Hyperphosphataemia

Initiation and stabilization

Compliance with Written or Telephone Authority Required procedures

C5491

Hyperphosphataemia

Maintenance following initiation and stabilization

Compliance with Authority Required procedures - Streamlined Authority Code 5491

C5530

Where the patient is receiving treatment at/from a public hospital

Hyperphosphataemia

Initiation and stabilization

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5530

Schedule 4, Part 1, entry for Testosterone
substitute:

Testosterone	C5449	Micropenis Patient must be under 18 years of age. Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The name of the specialist must be included in the authority application.	Compliance with Authority Required procedures
C5460	Pubertal induction Patient must be under 18 years of age. Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The name of the specialist must be included in the authority application.	Compliance with Authority Required procedures
C5471	Constitutional delay of growth or puberty Patient must be under 18 years of age. Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The name of the specialist must be included in the authority application.	Compliance with Authority Required procedures
C5474	Androgen deficiency Patient must not have an established pituitary or testicular disorder; AND The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs. Patient must be aged 40 years or older. Must be treated by a specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. Androgen deficiency is defined as: (i) testosterone level of less than 6 nmol per litre; OR (ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher). Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings. The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated. The name of the specialist must be included in the authority application.	Compliance with Authority Required procedures
C5511	Androgen deficiency Patient must have an established pituitary or testicular disorder. Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists. The name of the specialist must be included in the authority application.	Compliance with Authority Required procedures

Schedule 4, Part 1, entry for Tiotropium
insert in numerical order:

C5509

Bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease

Long-term maintenance treatment

Schedule 4, Part 1, entry for Tobramycin
(a)omit:

C1169	Infections where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
C1188	Invasive ocular infection
C1391	Suspected pseudomonal eye infection
C1714	Perioperative use in ophthalmic surgery
C1846	Septicaemia, suspected
C1847	Septicaemia, proven
C3190	Systemic treatment of Pseudomonas aeruginosa infection in a patient with cystic fibrosis
C3842	Management of a proven Pseudomonas aeruginosa infection in a patient with cystic fibrosis	Compliance with Authority Required procedures – Streamlined Authority Code 3842

(b)insert in numerical order after existing text:

C5446	Septicaemia, suspected
C5451	Perioperative use in ophthalmic surgery
C5476	Perioperative use in ophthalmic surgery
C5477	Suspected Pseudomonal eye infection
C5483	Invasive ocular infection
C5490	Septicaemia, proven
C5498	Pseudomonas aeruginosa infection Patient must have cystic fibrosis; AND The treatment must be systemic.
C5499	Suspected Pseudomonal eye infection
C5519	Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent

C5520

Proven Pseudomonas aeruginosa infection

Patient must have cystic fibrosis; AND
The treatment must be for management.

Compliance with Authority Required procedures - Streamlined Authority Code 5520

Schedule 4, Part 1, after entry for Tobramycin
insert:

Tofacitinib	C5480	P5480	Severe active rheumatoid arthritis Initial treatment - Initial 3 (Grandfather patients) Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have been receiving treatment with this drug for this condition prior to 1 October 2015; AND Patient must be receiving treatment with this drug for this condition at the time of application; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and (c) a signed patient acknowledgement. All applications for treatment with this drug for this condition under this restriction must include baseline joint count and ESR and/or CRP as determined at the completion of a 6 month intensive DMARD trial but prior to ceasing DMARD therapy. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. A patient may qualify for PBS-subsidised treatment under this restriction once only.	Compliance with Written Authority Required procedures
C5496	P5496	Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months) Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. The authority application must be made in writing and must include: (a) a completed authority prescription form and (b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. Application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased. If a patient fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) 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 (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/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).	Compliance with Written Authority Required procedures
C5504	P5504	Severe active rheumatoid arthritis Continuing treatment Patient must have a documented history of severe active rheumatoid arthritis; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) 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 (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/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). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form. All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C5510	P5510	Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) Patient must have severe active rheumatoid arthritis; AND Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab or tofacitinib. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and (3) a signed patient acknowledgement. Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: 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) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/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). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.	Compliance with Written Authority Required procedures

Schedule 4, Part 1, entry for Topiramate
(a)omit:

C5290

Seizures

Patient must have partial epileptic seizures; OR
Patient must have primary generalised tonic-clonic seizures; OR
Patient must have seizures of the Lennox-Gastaut syndrome; AND
The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; AND
Patient must be unable to take a solid dose form of topiramate

Compliance with Authority Required procedures - Streamlined Authority Code 5290

(b)insert in numerical order after existing text:

C5516

Seizures

Compliance with Authority Required procedures - Streamlined Authority Code 5516

Schedule 4, Part 1, entry for Zolmitriptan
substitute:

Zolmitriptan

C5489

Migraine attack

The condition must have usually failed to respond to analgesics in the past.