National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 1) (PB 1 of 2016) (Cth)
PB 1 of 2016
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016
(No. 1)National Health Act 1953
I, JULIANNE QUAINE, First Assistant Secretary (Acting), 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 28 January 2016
JULIANNE QUAINE
First Assistant Secretary (Acting)
Pharmaceutical Benefits Division
Department of Health1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2016 (No. 1).
(2) This Instrument may also be cited as PB 1 of 2016.
2 Commencement
This Instrument commences on 1 February 2016.
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
[1]Schedule 1, entry for Acetazolamide
omit from the column headed “Responsible Person”: QA substitute: RW
[2]Schedule 1, entry for Alendronic Acid
omit from the column headed “Responsible Person” for the brand “Alendro Once Weekly”: QA substitute: RW
[3]Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a APO-Alendronate Plus D3 70 mg/70 mcg TX MP NP C4070 C4087 C4110 4 5 4 (c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Chem mart Alendronate Plus D3 70 mg/70 mcg CH MP NP C4070 C4087 C4110 4 5 4 (d)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Terry White Chemists Alendronate Plus D3 70 mg/70 mcg TW MP NP C4070 C4087 C4110 4 5 4 [4]Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a APO-Alendronate Plus D3 70 mg/140 mcg TX MP NP C4122 C4123 C4133 4 5 4 (c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Chem mart Alendronate Plus D3 70 mg/140 mcg CH MP NP C4122 C4123 C4133 4 5 4 (d)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Terry White Chemists Alendronate Plus D3 70 mg/140 mcg TW MP NP C4122 C4123 C4133 4 5 4 [5] Schedule 1, entry for Allopurinol in the form Tablet 100 mg
(a)omit from the column headed “Responsible Person” for the brand “Allosig”: FM substitute: RF
(b)omit from the column headed “Responsible Person” for the brand “Zyloprim”: QA substitute: RW
[6]Schedule 1, entry for Allopurinol in the form Tablet 300 mg
(a)omit from the column headed “Responsible Person” for the brand “Allosig”: FM substitute: RF
(b)omit from the column headed “Responsible Person” for the brand “Zyloprim”: QA substitute: RW
[7]Schedule 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 10 mg
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Amitriptyline Alphapharm 10 AL MP NP 50 2 50 [8]Schedule 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 25 mg
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Amitriptyline Alphapharm 25 AL MP NP 50 2 50 [9]Schedule 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 50 mg
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Amitriptyline Alphapharm 50 AL MP NP 50 2 50 [10]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 brands “Amlo 5” and “Amlo 10” respectively: QA substitute: RW
[11]Schedule 1, entry for Amoxycillin in each of the forms: Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL; and Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL
omit from the column headed “Responsible Person” for the brand “Bgramin” (all instances): GN substitute: FM
[12]Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 20 mg in 2 mL
(a)insert in the column headed “Schedule Equivalent” for the brand “Apomine”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Movapo TD MP C4833 C4860 360 5 5 D(100) [13]Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL
(a)insert in the column headed “Schedule Equivalent” for the brand “Apomine”: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Movapo TD MP C4833 C4860 180 5 5 D(100) [14]Schedule 1, entry for Baclofen in each of the forms: Tablet 10 mg; and Tablet 25 mg
omit from the column headed “Responsible Person” for the brands “Stelax 10” and “Stelax 25” respectively: QA substitute: RW
[15]Schedule 1, entry for Benzhexol in each of the forms: Tablet containing benzhexol hydrochloride 2 mg; and Tablet containing benzhexol hydrochloride 5 mg
omit from the column headed “Responsible Person”: QA substitute: RW
[16]Schedule 1, entry for Bisoprolol in each of the forms: Tablet containing bisoprolol fumarate 2.5 mg; Tablet containing bisoprolol fumarate
5 mg; and Tablet containing bisoprolol fumarate 10 mgomit from the column headed “Responsible Person” for the brands “Bicard 2.5”, “Bicard 5” and “Bicard 10” respectively: QA substitute: RW
[17]Schedule 1, entry for Captopril in each of the forms: Tablet 25 mg; Tablet 50 mg; and Oral solution 5 mg per mL, 95 mL
omit from the column headed “Responsible Person” for the brand “Capoten”: QA substitute: RW
[18]Schedule 1, entry for Cephalexin in the form Capsule 250 mg (anhydrous)
(a)omit:
GenRx Cephalexin GX PDP 20 0 20 (b)omit:
GenRx Cephalexin GX MP NP MW 20 1 20 (c)omit:
GenRx Cephalexin GX MP P4243 40 2 20 [19]Schedule 1, entry for Cephalexin in the form Capsule 500 mg (anhydrous)
(a)omit:
GenRx Cephalexin GX PDP 20 0 20 (b)omit:
GenRx Cephalexin GX MP NP MW 20 1 20 [20]Schedule 1, entry for Ciprofloxacin in each of the forms: Tablet 250 mg (as hydrochloride); Tablet 500 mg (as hydrochloride); and Tablet
750 mg (as hydrochloride)omit from the column headed “Responsible Person” for the brands “Ciprol 250”, “Ciprol 500” and “Ciprol 750” respectively: QA substitute: RW
[21]Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
omit from the column headed “Responsible Person” for the brand “Talam”: QA substitute: RW
[22]Schedule 1, entry for Clarithromycin in the form Tablet 250 mg
omit from the column headed “Responsible Person” for the brand “Clarithro 250”: QA substitute: RW
[23]Schedule 1, entry for Diazepam in each of the forms: Tablet 2 mg; and Tablet 5 mg
omit from the column headed “Responsible Person” for the brands “Valpam 2” and “Valpam 5” respectively (all instances): QA substitute: RW
[24]Schedule 1, entry for Docetaxel
omit:
Solution concentrate for I.V. infusion 20 mg in 1 mL Injection Taxotere SW MP See Note 3 See
Note 31 D(100) [25]Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL
omit:
Taxotere SW MP See Note 3 See
Note 31 D(100) [26]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 brands “Aridon 5” and “Aridon 10” respectively: QA substitute: RW
[27]Schedule 1, entry for Doxycycline in the form Tablet 100 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Doxsig” (all instances): QA substitute: RW
[28]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
(a)omit:
Auspril QA MP NP 30 5 30 (b)omit from the column headed “Responsible Person” for the brand “Malean”: FM substitute: RW
[29]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 brands “Lexam 10” and “Lexam 20” respectively: QA substitute: RW
[30]Schedule 1, entry for Esomeprazole
omit:
Capsule (enteric) 20 mg (as magnesium) Oral Noxicid Caps AL MP NP C4988 C5029 C5030 C5039 P4988 30 1 30 MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30 Capsule (enteric) 40 mg (as magnesium) Oral Noxicid Caps AL MP NP C5011 C5021 C5028 P5028 30 1 30 MP NP C5011 C5021 C5028 P5011 P5021 30 5 30 substitute:
Capsule (enteric) 20 mg (as magnesium) Oral Esomeprazole ACTAVIS EA MP NP C4988 C5029 C5030 C5039 P4988 30 1 30 Noxicid Caps AL MP NP C4988 C5029 C5030 C5039 P4988 30 1 30 Esomeprazole ACTAVIS EA MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30 Noxicid Caps AL MP NP C4988 C5029 C5030 C5039 P5029 P5030 P5039 30 5 30 Capsule (enteric) 40 mg (as magnesium) Oral Esomeprazole ACTAVIS EA MP NP C5011 C5021 C5028 P5028 30 1 30 Noxicid Caps AL MP NP C5011 C5021 C5028 P5028 30 1 30 Esomeprazole ACTAVIS EA MP NP C5011 C5021 C5028 P5011 P5021 30 5 30 Noxicid Caps AL MP NP C5011 C5021 C5028 P5011 P5021 30 5 30 [31]Schedule 1, entry for Famciclovir in each of the forms: Tablet 125 mg; Tablet 250 mg; and Tablet 500 mg
omit from the column headed “Responsible Person” for the brands “Favic 125”, “Favic 250” and “Favic 500” respectively (all instances):
QA substitute: RW
[32]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 brands “Ausfam 20” and “Ausfam 40” respectively: QA substitute: RW
[33]Schedule 1, entry for Felodipine in each of the forms: Tablet 5 mg (extended release); and Tablet 10 mg (extended release)
omit from the column headed “Responsible Person” for the brands “Felodil XR 5” and “Felodil XR 10” respectively: QA substitute: RW
[34]Schedule 1, entry for Fentanyl
omit:
Lozenge 200 micrograms (as citrate) Buccal Actiq TB MP NP C4250 C4914 P4250 9 0 9 MP NP C4250 C4914 P4914 60 0 30 Lozenge 400 micrograms (as citrate) Buccal Actiq TB MP NP C4250 C4914 P4250 9 0 9 MP NP C4250 C4914 P4914 60 0 30 Lozenge 600 micrograms (as citrate) Buccal Actiq TB MP NP C4250 C4914 P4250 9 0 9 MP NP C4250 C4914 P4914 60 0 30 Lozenge 800 micrograms (as citrate) Buccal Actiq TB MP NP C4250 C4914 P4250 9 0 9 MP NP C4250 C4914 P4914 60 0 30 Lozenge 1200 micrograms (as citrate) Buccal Actiq TB MP NP C4250 C4914 P4250 9 0 9 MP NP C4250 C4914 P4914 60 0 30 Lozenge 1600 micrograms (as citrate) Buccal Actiq TB MP NP C4250 C4914 P4250 9 0 9 MP NP C4250 C4914 P4914 60 0 30 substitute:
Lozenge 200 micrograms (as citrate) Buccal Actiq TB MP NP C5904 C5915 P5915 9 0 9 MP NP C5904 C5915 P5904 60 0 30 Lozenge 400 micrograms (as citrate) Buccal Actiq TB MP NP C5904 C5915 P5915 9 0 9 MP NP C5904 C5915 P5904 60 0 30 Lozenge 600 micrograms (as citrate) Buccal Actiq TB MP NP C5904 C5915 P5915 9 0 9 MP NP C5904 C5915 P5904 60 0 30 Lozenge 800 micrograms (as citrate) Buccal Actiq TB MP NP C5904 C5915 P5915 9 0 9 MP NP C5904 C5915 P5904 60 0 30 Lozenge 1200 micrograms (as citrate) Buccal Actiq TB MP NP C5904 C5915 P5915 9 0 9 MP NP C5904 C5915 P5904 60 0 30 Lozenge 1600 micrograms (as citrate) Buccal Actiq TB MP NP C5904 C5915 P5915 9 0 9 MP NP C5904 C5915 P5904 60 0 30 Tablet (sublingual) 100 micrograms (as citrate) Sublingual Abstral FK MP NP C5904 C5915 P5915 10 0 10 MP NP C5904 C5915 P5904 60 0 30 Tablet (sublingual) 200 micrograms (as citrate) Sublingual Abstral FK MP NP C5904 C5915 P5915 10 0 10 MP NP C5904 C5915 P5904 60 0 30 Tablet (sublingual) 300 micrograms (as citrate) Sublingual Abstral FK MP NP C5904 C5915 P5915 10 0 10 MP NP C5904 C5915 P5904 60 0 30 Tablet (sublingual) 400 micrograms (as citrate) Sublingual Abstral FK MP NP C5904 C5915 P5915 10 0 10 MP NP C5904 C5915 P5904 60 0 30 Tablet (sublingual) 600 micrograms (as citrate) Sublingual Abstral FK MP NP C5904 C5915 P5915 10 0 10 MP NP C5904 C5915 P5904 60 0 30 Tablet (sublingual) 800 micrograms (as citrate) Sublingual Abstral FK MP NP C5904 C5915 P5915 10 0 10 MP NP C5904 C5915 P5904 60 0 30 [35]Schedule 1, entry for Flucloxacillin in the form Powder for injection 1 g (as sodium)
(a)omit:
Hospira Pty Limited HH PDP 5 0 5 substitute:
Hospira Pty Limited HH PDP 5 0 5 PDP 5 0 10 (b)omit:
Hospira Pty Limited HH MP NP 5 1 5 substitute:
Hospira Pty Limited HH MP NP 5 1 5 MP NP 5 1 10 [36]Schedule 1, entry for Fluconazole in the form Capsule 200 mg
omit from the column headed “Responsible Person” for the brand “Fluzole 200”: QA substitute: RW
[37]Schedule 1, entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Auscap Aspen”: QA substitute: RW
[38]Schedule 1, entry for Fosinopril in each of the forms: Tablet containing fosinopril sodium 10 mg; and Tablet containing fosinopril sodium 20 mg
omit from the column headed “Responsible Person” for the brands “Fosipril 10” and “Fosipril 20” respectively: QA substitute: RW
[39]Schedule 1, entry for Frusemide in each of the forms: Tablet 20 mg; Tablet 40 mg; and Tablet 500 mg
omit from the column headed “Responsible Person” for the brands “Urex-M”, “Urex” and “Urex-Forte” respectively: FM substitute: RW
[40]Schedule 1, entry for Gabapentin in each of the forms: Capsule 100 mg; Capsule 300 mg; Capsule 400 mg; Tablet 600 mg; and
Tablet 800 mgomit from the column headed “Responsible Person” for the brands “Gabapentin Aspen 100”, “Gabapentin Aspen 300”, “Gabapentin Aspen 400”,
“Gabapentin Aspen 600” and “Gabapentin Aspen 800” respectively: FM substitute: RW[41]Schedule 1, entry for Gemfibrozil in the form Tablet 600 mg
omit from the column headed “Responsible Person” for the brand “Ausgem” (twice occurring): QA substitute: RW
[42]Schedule 1, entry for Gliclazide in the form Tablet 80 mg
omit from the column headed “Responsible Person” for the brand “Nidem”: QA substitute: RW
[43]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 “Diapride 1”, “Diapride 2”, “Diapride 3”, and “Diapride 4” respectively:
QA substitute: RW[44]Schedule 1, entry for Glyceryl Trinitrate in the form Tablets 600 micrograms, 100
(a)omit from the column headed “Responsible Person” for the brand “Anginine Stabilised” (twice occurring): QA substitute: RW
(b)omit from the column headed “Responsible Person” for the brand “Lycinate” (twice occurring): FM substitute: RF
[45]Schedule 1, entry for Hydroxychloroquine
omit from the column headed “Responsible Person” for the brand “Hequinel”: QA substitute: RW
[46]Schedule 1, entry for IncobotulinumtoxinA
omit from the column headed “Maximum Quantity”: 3 substitute: 4
[47]Schedule 1, entry for Indapamide in each of the forms: Tablet containing indapamide hemihydrate 1.5 mg (sustained release); and
Tablet containing indapamide hemihydrate 2.5 mgomit from the column headed “Responsible Person” for the brands “Tenaxil SR” and “Insig” respectively: QA substitute: RW
[48]Schedule 1, after entry for Insect Allergen Extract–Honey Bee Venom in the form Injection set containing 550 micrograms
insert in the columns in the order indicated:
Injection set containing 550 micrograms with diluent Injection Hymenoptera Honey Bee Venom DE MP 1 0 1 [49]Schedule 1, after entry for Insect Allergen Extract–Paper Wasp Venom in the form Injection set containing 550 micrograms
insert in the columns in the order indicated:
Injection set containing 550 micrograms with diluent Injection Hymenoptera Paper Wasp Venom DE MP 1 0 1 [50]Schedule 1, after entry for Insect Allergen Extract–Yellow Jacket Venom in the form Injection set containing 550 micrograms
insert in the columns in the order indicated:
Injection set containing 550 micrograms with diluent Injection Hymenoptera Yellow Jacket Venom DE MP 1 0 1 [51]Schedule 1, entry for Irbesartan in the form Tablet 75 mg
omit:
Karbesat 75 QA MP NP 30 5 30 [52]Schedule 1, entry for Irbesartan in the form Tablet 150 mg
omit:
Karbesat 150 QA MP NP 30 5 30 [53]Schedule 1, entry for Irbesartan in the form Tablet 300 mg
omit:
Karbesat 300 QA MP NP 30 5 30 [54]Schedule 1, entry for Isoniazid
(a)omit from the column headed “Brand”: Fawns and McAllan Proprietary Limited substitute: Arrow Pharma Pty Ltd
(b)omit from the column headed “Responsible Person”: FM substitute: RW
[55]Schedule 1, entry for Isotretinoin in each of the forms: Capsule 10 mg; and Capsule 20 mg
omit from the column headed “Responsible Person” for the brands “Rocta 10” and “Rocta 20” respectively: QA substitute: RW
[56]Schedule 1, entry for Lamivudine in each of the forms: Tablet 100 mg; and Oral solution 5 mg per mL, 240 mL
omit from the column headed “Responsible Person” for the brand “Zeffix”: AS substitute: RW
[57]Schedule 1, entry for Lamotrigine in the form Tablet 5 mg
(a)omit from the column headed “Responsible Person” for the brand “Lamotrigine Aspen 5”: FM substitute: RW
(b)omit:
Seaze 5 QA MP NP C5138 56 5 56 [58]Schedule 1, entry for Lamotrigine in the form Tablet 25 mg
(a)omit from the column headed “Responsible Person” for the brand “Lamotrigine Aspen 25”: FM substitute: RW
(b)omit:
Seaze 25 QA MP NP C5138 56 5 56 [59] Schedule 1, entry for Lamotrigine in the form Tablet 50 mg
(a)omit from the column headed “Responsible Person” for the brand “Lamotrigine Aspen 50”: FM substitute: RW
(b)omit:
Seaze 50 QA MP NP C5138 56 5 56 [60]Schedule 1, entry for Lamotrigine in the form Tablet 100 mg
(a)omit from the column headed “Responsible Person” for the brand “Lamotrigine Aspen 100”: FM substitute: RW
(b)omit:
Seaze 100 QA MP NP C5138 56 5 56 [61]Schedule 1, entry for Lamotrigine in the form Tablet 200 mg
(a)omit from the column headed “Responsible Person” for the brand “Lamotrigine Aspen 200”: FM substitute: RW
(b)omit:
Seaze 200 QA MP NP C5138 56 5 56 [62]Schedule 1, entry for Levetiracetam in the form Tablet 250 mg
omit:
Levitam 250 QA MP NP C4928 60 5 60 [63] Schedule 1, entry for Levetiracetam in the form Tablet 500 mg
omit:
Levitam 500 QA MP NP C4928 60 5 60 [64]Schedule 1, entry for Levetiracetam in the form Tablet 1 g
omit:
Levitam 1000 QA MP NP C4928 60 5 60 [65]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 brands “Fibsol 5”,“Fibsol 10” and “Fibsol 20” respectively: QA substitute: RW
[66]Schedule 1, entry for Meloxicam in each of the forms: Tablet 7.5 mg; Tablet 15 mg; Capsule 7.5 mg; and Capsule 15 mg
omit from the column headed “Responsible Person” for the brands “Movalis 7.5”,“Movalis 15”, “Movalis 7.5” and “Movalis 15” respectively:
QA substitute: RW[67]Schedule 1, entry for Metformin in each of the forms: Tablet (extended release) containing metformin hydrochloride 500 mg; and
Tablet containing metformin hydrochloride 1 gomit from the column headed “Responsible Person” for the brands “Metex SR” and “Formet 1000” respectively: QA substitute: RW
[68]Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)
omit:
Montelukast RBX RA MP NP C2617 28 5 28 [69]Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)
omit:
Montelukast RBX RA MP NP C2618 C3217 28 5 28 [70]Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 30 mg
omit from the column headed “Responsible Person”: FM substitute: RW
[71]Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 10 mg (controlled release)
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Morphine MR AN EA MP NP C4556 28 0 28 [72]Schedule 1, entry for Morphine in each of the forms: Tablet containing morphine sulfate 30 mg (controlled release); Tablet containing morphine sulfate 60 mg (controlled release); and Tablet containing morphine sulfate 100 mg (controlled release)
(c)insert in the column headed “Schedule Equivalent” for all brands: a
(d)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Morphine MR AN EA MP NP C4556 28 0 28 [73]Schedule 1, entry for Nicotine in each of the forms: Transdermal patch 17.5 mg; Transdermal patch 35 mg; and Transdermal patch 52.5 mg
omit from the column headed “Responsible Person”: NC substitute: ON
[74]Schedule 1, entry for Nizatidine in each of the forms: Capsule 150 mg; and Capsule 300 mg
(a)omit from the column headed “Responsible Person” for the brand “Nizac”: LN substitute: RF
(b)omit from the column headed “Responsible Person” for the brand “Tazac”: AS substitute: RW
[75]Schedule 1, entry for Norfloxacin
omit from the column headed “Responsible Person” for the brand “Roxin”: QA substitute: RW
[76]Schedule 1, entry for Nortriptyline in each of the forms: Tablet 10 mg (as hydrochloride); and Tablet 25 mg (as hydrochloride)
omit from the column headed “Responsible Person”: AS substitute: RW
[77]Schedule 1, entry for Octreotide in each of the forms: Injection (modified release) 10 mg (as acetate), vial and diluent syringe: Injection (modified release) 20 mg (as acetate), vial and diluent syringe; and Injection (modified release) 30 mg (as acetate), vial and diluent syringe
omit from the column headed “Circumstances”: C5628 C5654 C5678 C5707 C5737 C5738
substitute: C5896 C5899 C5900 C5901 C5906 C5910[78]Schedule 1, entry for Oxaliplatin in each of the forms: Solution concentrate for I.V. infusion 50 mg in 10 mL; Solution concentrate for I.V. infusion 100 mg in 20 mL; and Solution concentrate for I.V. infusion 200 mg in 40 mL
omit:
Eloxatin SW MP See Note 3 See
Note 31 D(100) [79]Schedule 1, entry for Oxazepam in the form Tablet 30 mg
omit from the column headed “Responsible Person” for the brand “Murelax” (all instances): FM substitute: RW
[80]Schedule 1, entry for Pantoprazole in each of the forms: Tablet (enteric coated) 20 mg (as sodium sesquihydrate); and Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
omit from the column headed “Responsible Person” for the brand “Sozol” (all instances): QA substitute: RW
[81]Schedule 1, entry for Paroxetine in the form Tablet 20 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Extine 20”: QA substitute: RW
[82]Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 100 mg (as disodium heptahydrate)
(a)omit from the column headed “Form”: heptahydrate
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
DBL Pemetrexed HH MP C4789 C4792 See Note 3 See
Note 31 D(100) (c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pemetrexed APOTEX TX MP C4789 C4792 See Note 3 See
Note 31 D(100) (d)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pemetrexed Juno JU MP C4789 C4792 See Note 3 See
Note 31 D(100) (e)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Reladdin AF MP C4789 C4792 See Note 3 See
Note 31 D(100) [83]Schedule 1, entry for Pemetrexed in the form Powder for I.V. infusion 500 mg (as disodium heptahydrate)
(a)omit from the column headed “Form”: heptahydrate
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
DBL Pemetrexed HH MP C4789 C4792 See Note 3 See
Note 31 D(100) (c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pemetrexed APOTEX TX MP C4789 C4792 See Note 3 See
Note 31 D(100) (d)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pemetrexed DRLA RZ MP C4789 C4792 See Note 3 See
Note 31 D(100) (e)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Pemetrexed Juno JU MP C4789 C4792 See Note 3 See
Note 31 D(100) (f)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Reladdin AF MP C4789 C4792 See Note 3 See
Note 31 D(100) [84]Schedule 1, entry for Perindopril in each of the forms: Tablet containing perindopril erbumine 2 mg; Tablet containing perindopril erbumine 4 mg; and Tablet containing perindopril erbumine 8 mg
omit from the column headed “Responsible Person” for the brands “Indosyl Mono 2”,“Indosyl Mono 4” and “Indosyl Mono 8” respectively:
FM substitute: RW[85]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 “Indosyl Combi 4/1.25”: QA substitute: RW
[86]Schedule 1, entry for Phenobarbitone in the form Tablet 30 mg
(a)omit from the column headed “Brand”: Aspen Pharma Pty Ltd substitute: Phenobarbitone Aspen
(b)omit from the column headed “Responsible Person”: QA substitute: RW
[87]Schedule 1, entry for Pioglitazone in the form Tablet 15 mg (as hydrochloride)
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)omit from the column headed “Responsible Person” for the brand “Acpio 15”: QA substitute: RF
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Actaze RW MP NP C4363 C4364 C4388 28 5 28 [88]Schedule 1, entry for Pioglitazone in the form Tablet 30 mg (as hydrochloride)
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)omit from the column headed “Responsible Person” for the brand “Acpio 30”: QA substitute: RF
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Actaze RW MP NP C4363 C4364 C4388 28 5 28 [89]Schedule 1, entry for Pioglitazone in the form Tablet 45 mg (as hydrochloride)
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)omit from the column headed “Responsible Person” for the brand “Acpio 45”: QA substitute: RF
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a Actaze RW MP NP C4363 C4364 C4388 28 5 28 [90]Schedule 1, entry for Pramipexole in each of the forms: Tablet containing pramipexole hydrochloride 125 micrograms; Tablet containing pramipexole hydrochloride 250 micrograms; and Tablet containing pramipexole hydrochloride 1 mg
omit from the column headed “Responsible Person” for the brands “Simipex 0.125”,“Simipex 0.25” and “Simipex 1” respectively: QA substitute: RW
[91]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
(a)omit from the column headed “Responsible Person” for the brands “Lipostat 10”,“Lipostat 20”, “Lipostat 40” and “Lipostat 80” respectively (all instances):
QA substitute: RF(b)omit from the column headed “Responsible Person” for the brand “Pravachol” (all instances): FM substitute: RW
[92]Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg
omit from the column headed “Responsible Person” for the brand “ProCalm”: QA substitute: RW
[93]Schedule 1, entry for Propantheline
omit from the column headed “Responsible Person”: QA substitute: RW
[94]Schedule 1, entry for Pyrimethamine
omit from the column headed “Responsible Person”: AS substitute: RW
[95]Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
omit:
Seronia 100 QA MP NP C4246 C5611 C5639 90 5 90 [96]Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
omit:
Seronia 200 QA MP NP C4246 C5611 C5639 60 5 60 [97]Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
omit:
Seronia 300 QA MP NP C4246 C5611 C5639 60 5 60 [98]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 brands “Acquin Aspen 5”,“Acquin Aspen 10” and “Acquin Aspen 20” respectively:
AS substitute: RW[99]Schedule 1, entry for Quinine
omit from the column headed “Responsible Person”: AS substitute: RW
[100]Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity: 30;
Number of Repeats: 5]omit from the column headed “Purposes” (all instances): C5512 substitute: P5512
[101]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 “Ausran”: QA substitute: RW
[102]Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 35 mg
omit from the column headed “Responsible Person” for the brand “Risedro once a week”: QA substitute: RW
[103]Schedule 1, entry for Risperidone
substitute:
Risperidone I.M. injection (modified release), set containing 1 vial powder for injection 25 mg and 1 pre-filled syringe diluent 2 mL Injection Risperdal Consta JC MP NP C4246 C5912 2 5 1 I.M. injection (modified release), set containing 1 vial powder for injection 37.5 mg and 1 pre-filled syringe diluent 2 mL Injection Risperdal Consta JC MP NP C4246 C5912 2 5 1 I.M. injection (modified release), set containing 1 vial powder for injection 50 mg and 1 pre-filled syringe diluent 2 mL Injection Risperdal Consta JC MP NP C4246 C5912 2 5 1 Oral solution 1 mg per mL, 100 mL Oral Risperdal JC MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 1 2 1 MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 1 5 1 Tablet 0.5 mg Oral a APO-Risperidone TX MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 20 a Ozidal RA MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60 a Rispa RW MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60 a Risperdal JC MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 20 a Rispericor 0.5 CR MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60 a Risperidone Actavis 0.5 ED MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60 a Risperidone AN EA MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60 a Risperidone-DRLA RZ MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60 a Risperidone-GA EF MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60 a Risperidone GH GQ MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60 a Risperidone Sandoz SZ MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60 a Rispernia ER MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60 a Rixadone AF MP NP C5902 C5903 C5908 C5911 P5902 P5908 P5911 60 2 60 a APO-Risperidone TX MP NP C5902 C5903 C5908 C5911 P5903 60 5 20 a Ozidal RA MP NP C5902 C5903 C5908 C5911 P5903 60 5 20 a Rispa RW MP NP C5902 C5903 C5908 C5911 P5903 60 5 60 a Risperdal JC MP NP C5902 C5903 C5908 C5911 P5903 60 5 60 a Rispericor 0.5 CR MP NP C5902 C5903 C5908 C5911 P5903 60 5 60 a Risperidone Actavis 0.5 ED MP NP C5902 C5903 C5908 C5911 P5903 60 5 60 a Risperidone AN EA MP NP C5902 C5903 C5908 C5911 P5903 60 5 60 a Risperidone-DRLA RZ MP NP C5902 C5903 C5908 C5911 P5903 60 5 60 a Risperidone-GA EF MP NP C5902 C5903 C5908 C5911 P5903 60 5 60 a Risperidone GH GQ MP NP C5902 C5903 C5908 C5911 P5903 60 5 60 a Risperidone Sandoz SZ MP NP C5902 C5903 C5908 C5911 P5903 60 5 60 a Rispernia ER MP NP C5902 C5903 C5908 C5911 P5903 60 5 60 a Rixadone AF MP NP C5902 C5903 C5908 C5911 P5903 60 5 60 Tablet 0.5 mg (orally disintegrating) Oral Risperdal Quicklet JC MP NP C4246 C5897 C5898 C5916 P5897 P5898 P5916 56 2 28 MP NP C4246 C5897 C5898 C5916 P4246 56 5 28 Tablet 1 mg Oral a APO-Risperidone TX MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Ozidal RA MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Rispa RW MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Risperdal JC MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Rispericor 1 CR MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Risperidone Actavis 1 ED MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Risperidone AN EA MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Risperidone-DRLA RZ MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Risperidone-GA EF MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Risperidone generichealth GQ MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Risperidone Sandoz SZ MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Rispernia ER MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a Rixadone AF MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 60 2 60 a APO-Risperidone TX MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Ozidal RA MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Rispa RW MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperdal JC MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Rispericor 1 CR MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone Actavis 1 ED MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone AN EA MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone-DRLA RZ MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone-GA EF MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone generichealth GQ MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone Sandoz SZ MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Rispernia ER MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 a Rixadone AF MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 60 5 60 Tablet 1 mg (orally disintegrating) Oral Risperdal Quicklet JC MP NP C4246 C5897 C5898 C5907 C5916 P5897 P5898 P5916 56 2 28 MP NP C4246 C5897 C5898 C5907 C5916 P4246 P5907 56 5 28 Tablet 2 mg Oral a APO-Risperidone TX MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Ozidal RA MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Rispa RW MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Risperdal JC MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Rispericor 2 CR MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Risperidone Actavis 2 ED MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Risperidone AN EA MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Risperidone-DRLA RZ MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Risperidone-GA EF MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Risperidone generichealth GQ MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Risperidone Sandoz SZ MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Rispernia ER MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a Rixadone AF MP NP C4246 C5898 C5907 C5916 P5898 P5916 60 2 60 a APO-Risperidone TX MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Ozidal RA MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Rispa RW MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperdal JC MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Rispericor 2 CR MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone Actavis 2 ED MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone AN EA MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone-DRLA RZ MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone-GA EF MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone generichealth GQ MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Risperidone Sandoz SZ MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Rispernia ER MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 a Rixadone AF MP NP C4246 C5898 C5907 C5916 P4246 P5907 60 5 60 Tablet 2 mg (orally disintegrating) Oral Risperdal Quicklet JC MP NP C4246 C5898 C5907 C5916 P5898 P5916 56 2 28 MP NP C4246 C5898 C5907 C5916 P4246 P5907 56 5 28 Tablet 3 mg Oral a APO-Risperidone TX MP NP C4246 C5907 60 5 60 a Ozidal RA MP NP C4246 C5907 60 5 60 a Rispa RW MP NP C4246 C5907 60 5 60 a Risperdal JC MP NP C4246 C5907 60 5 60 a Rispericor 3 CR MP NP C4246 C5907 60 5 60 a Risperidone Actavis 3 ED MP NP C4246 C5907 60 5 60 a Risperidone AN EA MP NP C4246 C5907 60 5 60 a Risperidone-DRLA RZ MP NP C4246 C5907 60 5 60 a Risperidone-GA EF MP NP C4246 C5907 60 5 60 a Risperidone generichealth GQ MP NP C4246 C5907 60 5 60 a Risperidone Sandoz SZ MP NP C4246 C5907 60 5 60 a Rispernia ER MP NP C4246 C5907 60 5 60 a Rixadone AF MP NP C4246 C5907 60 5 60 Tablet 3 mg (orally disintegrating) Oral Risperdal Quicklet JC MP NP C4246 C5907 56 5 28 Tablet 4 mg Oral a APO-Risperidone TX MP NP C4246 C5907 60 5 60 a Ozidal RA MP NP C4246 C5907 60 5 60 a Rispa RW MP NP C4246 C5907 60 5 60 a Risperdal JC MP NP C4246 C5907 60 5 60 a Rispericor 4 CR MP NP C4246 C5907 60 5 60 a Risperidone AN EA MP NP C4246 C5907 60 5 60 a Risperidone-DRLA RZ MP NP C4246 C5907 60 5 60 a Risperidone-GA EF MP NP C4246 C5907 60 5 60 a Risperidone generichealth GQ MP NP C4246 C5907 60 5 60 a Risperidone Sandoz SZ MP NP C4246 C5907 60 5 60 a Rispernia ER MP NP C4246 C5907 60 5 60 a Rixadone AF MP NP C4246 C5907 60 5 60 Tablet 4 mg (orally disintegrating) Oral Risperdal Quicklet JC MP NP C4246 C5907 56 5 28
[104]Schedule 1, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Rizatriptan ODT GH GQ MP NP C5708 4 5 2 [105]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 brands “Roxar 150” and “Roxar 300” respectively (all instances): QA substitute: RW
[106]Schedule 1, after entry for Roxithromycin in the form Tablet 300 mg [Maximum Quantity: 5; Number of Repeats: 1; Brand: Terry White Chemists Roxithromycin]
insert:
Ruxolitinib Tablet 5 mg Oral Jakavi NV MP C5917 C5918 C5919 C5920 C5921 P5918 P5921 112 0 56 MP C5917 C5918 C5919 C5920 C5921 P5917 P5919 P5920 112 5 56 Tablet 15 mg Oral Jakavi NV MP C5917 C5918 C5919 C5920 C5921 P5918 P5921 56 0 56 MP C5917 C5918 C5919 C5920 C5921 P5917 P5919 P5920 56 5 56 Tablet 20 mg Oral Jakavi NV MP C5917 C5918 C5919 C5920 C5921 P5918 P5921 56 0 56 MP C5917 C5918 C5919 C5920 C5921 P5917 P5919 P5920 56 5 56 [107] Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brands “Sertra 50” and “Sertra 100” respectively: QA substitute: RW
[108]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 “Simvar 10”, “Simvar 20”, “Simvar 40” and “Simvar 80” respectively (all instances):
QA substitute: RW[109]Schedule 1, entry for Sotalol in each of the forms: Tablet containing sotalol hydrochloride 80 mg; and Tablet containing sotalol hydrochloride 160 mg
(a)omit from the column headed “Responsible Person” for the brand “Solavert”: QA substitute: RF
(b)omit from the column headed “Responsible Person” for the brand “Sotacor”: FM substitute: RW
[110]Schedule 1, entry for Stavudine
omit:
Capsule 20 mg Oral Zerit BQ MP C4454 C4512 120 5 60 D(100) [111]Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)
omit from the column headed “Responsible Person” for the brand “Sumagran Aspen 50”: AS substitute: RW
[112]Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 100; Number of Repeats: 3]
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a TACROLIMUS APOTEX TX MP 100 3 100 [113]Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg [Maximum Quantity: 200; Number of Repeats: 5]
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a TACROLIMUS APOTEX TX MP P5569 P5602 200
CN5569 CN56025
CN5569 CN5602100 C(100) [114]Schedule 1, entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 100; Number of Repeats: 3]
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a TACROLIMUS APOTEX TX MP 100 3 100 [115]Schedule 1, entry for Tacrolimus in the form Capsule 1 mg [Maximum Quantity: 200; Number of Repeats: 5]
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a TACROLIMUS APOTEX TX MP P5569 P5602 200
CN5569 CN56025
CN5569 CN5602100 C(100) [116]Schedule 1, entry for Tacrolimus in the form Capsule 5 mg [Maximum Quantity: 50; Number of Repeats: 3]
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a TACROLIMUS APOTEX TX MP 50 3 50 [117]Schedule 1, entry for Tacrolimus in the form Capsule 5 mg [Maximum Quantity: 100; Number of Repeats: 5]
(a)insert in the column headed “Schedule Equivalent” for all brands: a
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
a TACROLIMUS APOTEX TX MP P5569 P5602 100
CN5569 CN56025
CN5569 CN560250 C(100) [118]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 “Teltartan”: QA substitute: RW
[119]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 mgomit from the column headed “Responsible Person” for the brands “Teltartan HCT 40/12.5”, “Teltartan HCT 80/12.5” and “Teltartan HCT 80/25” respectively: QA substitute: RW
[120]Schedule 1, entry for Terbinafine in the form Tablet 250 mg (as hydrochloride)
omit from the column headed “Responsible Person” for the brand “Tamsil” (twice occurring): QA substitute: RW
[121]Schedule 1, entry for Thalidomide in each of the forms: Capsule 50 mg; and Capsule 100 mg
omit from the column headed “Circumstances”: C1233 C3342 substitute: C5909 C5914
[122]Schedule 1, entry for Ticarcillin with Clavulanic Acid
omit from the column headed “Circumstances” [Authorised Prescriber PDP]:C5831 substitute: C5905
[123]Schedule 1, entry for Topiramate 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 brands “Epiramax 25”, “Epiramax 50”, “Epiramax 100” and “Epiramax 200” respectively:
QA substitute: RW
[124]Schedule 1, entry for Trandolapril in each of the forms: Capsule 500 micrograms; Capsule 1 mg; Capsule 2 mg; and Capsule 4 mg
omit from the column headed “Responsible Person” for the brands “Dolapril 0.5”, “Dolapril 1”, “Dolapril 2” and “Dolapril 4” respectively:
QA substitute: RW[125]Schedule 1, entry for Trimethoprim
omit from the column headed “Responsible Person” for the brand “Triprim” (twice occurring): QA substitute: RW
[126]Schedule 1, entry for Trimethoprim with Sulfamethoxazole in the form Tablet 160 mg-800 mg
omit from the column headed “Responsible Person” for the brand “Septrin Forte” (twice occurring): QA substitute: RW
[127]Schedule 1, entry for Trimethoprim with Sulfamethoxazole in the form Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL
omit from the column headed “Responsible Person” for the brand “Septrin” (twice occurring): QA substitute: RW
[128]Schedule 1, entry for Valaciclovir
(a)omit from the column headed “Responsible Person” for the brand “Valnir” (all instances): QA substitute: OW
(b)omit from the column headed “Responsible Person” for the brand “Valtrex” (all instances): AS substitute: RW
(c)omit from the column headed “Responsible Person” for the brand “Zelitrex” (all instances): FM substitute: RF
[129]Schedule 1, entry for Valproic Acid in each of the forms: Tablet (enteric coated) containing sodium valproate 200 mg; and Tablet (enteric coated) containing sodium valproate 500 mg
omit from the column headed “Responsible Person” for the brands “Valprease 200” and “Valprease 500” respectively: QA substitute: RW
[130]Schedule 1, entry for Verapamil in each of the forms: Capsule containing verapamil hydrochloride 160 mg (sustained release); and Capsule containing verapamil hydrochloride 240 mg (sustained release)
omit from the column headed “Responsible Person” for the brand “Veracaps SR”: QA substitute: RW
[131]Schedule 1, entry for Voriconazole
omit:
Tablet 50 mg Oral Vfend PF MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56 C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 C5748 56 2 56 Tablet 200 mg Oral Vfend PF MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56 C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 C5748 56 2 56 substitute:
Tablet 50 mg Oral a Vfend PF MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56 a Voriconazole Sandoz SZ MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56 a Vfend PF MP NP C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 C5748 56 2 56 a Voriconazole Sandoz SZ MP NP C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 C5748 56 2 56 Tablet 200 mg Oral a Vfend PF MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56 a Voriconazole Sandoz SZ MP NP C4683 C4685 C5692 C5725 C5748 P4685 56 0 56 a Vfend PF MP NP C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 P5748 56 2 56 a Voriconazole Sandoz SZ MP NP C4683 C4685 C5692 C5725 C5748 P4683 P5692 P5725 P5748 56 2 56 [132]Schedule 3, after details relevant to Responsible Person code OS
insert:
OW Arrow Pharma Pty Ltd 35 605 909 920 [133]Schedule 3, after details relevant to Responsible Person code RD
insert:
RF Arrow Pharma Pty Ltd 35 605 909 920 [134]Schedule 3, after details relevant to Responsible Person code RO
insert:
RW Arrow Pharma Pty Ltd 35 605 909 920 [135]Schedule 3, after details relevant to Responsible Person code TB
insert:
TD Stada Pharmaceuticals Australia Pty Limited 73 154 966 944 [136]Schedule 4, Part 1, entry for Fentanyl
(a)omit:
C4250 P4250 Breakthrough pain
Initial treatment for dose titration
Patient must be undergoing palliative care;
Patient must have cancer;
Patient must be receiving opioids for their persistent pain;
Patient must be unable to tolerate further escalation in the dose of morphine for breakthrough pain due to adverse effectsCompliance with Authority Required procedures C4914 Breakthrough pain
Continuing treatment
Patient must have cancer; AND
Patient must be receiving opioids for their persistent pain; AND
Patient must be unable to tolerate further escalation in the dose of morphine for breakthrough pain due to adverse effectsPatient must be undergoing palliative care
Compliance with Authority Required procedures
(b)insert in numerical order after existing text:
C5904 P5904 Breakthrough pain
Continuing treatment
Patient must have cancer; AND
Patient must have pain directly attributable to cancer; AND
Patient must be assessed as receiving adequate management of their persistent pain with opioids; AND
Patient must have previously experienced inadequate pain relief following adequate doses of short acting opioids for the treatment of breakthrough pain; OR
The treatment must be used as short acting opioids are considered clinically inappropriate; OR
Patient must have previously experienced adverse effects following the use of short acting opioids for breakthrough pain.Patient must be undergoing palliative care.
Compliance with Authority Required procedures C5915 P5915 Breakthrough pain
Initial treatment for dose titration
Patient must have cancer; AND
Patient must have pain directly attributable to cancer; AND
Patient must be assessed as receiving adequate management of their persistent pain with opioids; AND
Patient must have previously experienced inadequate pain relief following adequate doses of short acting opioids for the treatment of breakthrough pain; OR
The treatment must be used as short acting opioids are considered clinically inappropriate; OR
Patient must have previously experienced adverse effects following the use of short acting opioids for breakthrough pain.Patient must be undergoing palliative care.
Compliance with Written or Telephone Authority Required procedures [137]Schedule 4, Part 1, entry for Octreotide
(a)omit:
C5628 Where the patient is receiving treatment at/from a private hospital
Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures C5654 Where the patient is receiving treatment at/from a private hospital
Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.Compliance with Written or Telephone Authority Required procedures C5678 Where the patient is receiving treatment at/from a public hospital
Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5678 C5707 Where the patient is receiving treatment at/from a private hospital
Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures C5737 Where the patient is receiving treatment at/from a public hospital
Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5737 C5738 Where the patient is receiving treatment at/from a public hospital
Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5738 (b)insert in numerical order after existing text:
C5896 Where the patient is receiving treatment at/from a private hospital
Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Written or Telephone Authority Required procedures C5899 Where the patient is receiving treatment at/from a private hospital
Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures C5900 Where the patient is receiving treatment at/from a public hospital
Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remissionCompliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5900 C5901 Where the patient is receiving treatment at/from a public hospital
Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5901 C5906 Where the patient is receiving treatment at/from a public hospital
Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5906 C5910 Where the patient is receiving treatment at/from a private hospital
Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.Compliance with Written or Telephone Authority Required procedures
[138]Schedule 4, Part 1, entry for Risperidone
substitute:
Risperidone C4246 P4246 Schizophrenia Compliance with Authority Required procedures - Streamlined Authority Code 4246 C5897 P5897 Behavioural disturbances
The condition must be characterised by psychotic symptoms and aggression; AND
Patient must have dementia; AND
Patient must have failed to respond to non-pharmacological methods of treatment.Compliance with Authority Required procedures - Streamlined Authority Code 5897 C5898 P5898 Severe behavioural disturbances
Continuing treatment
Patient must have autism; AND
Patient must have been commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be aged 18 years or older.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or ICD-10 international classification of mental and behavioural disorders.Compliance with Authority Required procedures - Streamlined Authority Code 5898 C5902 P5902 Severe behavioural disturbances
Continuing treatment
Patient must have autism; AND
Patient must have been commenced on PBS-subsidised treatment with risperidone prior to turning 18 years of age; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be aged 18 years or older.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or ICD-10 international classification of mental and behavioural disorders.Compliance with Authority Required procedures - Streamlined Authority Code 5902 C5903 P5903 Schizophrenia Compliance with Authority Required procedures - Streamlined Authority Code 5903 C5907 P5907 Acute mania
The condition must be associated with bipolar I disorder; AND
The treatment must be as adjunctive therapy to mood stabilisers; AND
The treatment must be limited to up to 6 months per episode.Compliance with Authority Required procedures - Streamlined Authority Code 5907 C5908 P5908 Behavioural disturbances
The condition must be characterised by psychotic symptoms and aggression; AND
Patient must have dementia; AND
Patient must have failed to respond to non-pharmacological methods of treatment.Compliance with Authority Required procedures - Streamlined Authority Code 5908 C5911 P5911 Severe behavioural disturbances
Patient must have autism; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be under 18 years of age.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or ICD-10 international classification of mental and behavioural disorders.Compliance with Authority Required procedures - Streamlined Authority Code 5911 C5912 P5912 Bipolar I disorder
The condition must be refractory to treatment; AND
The treatment must be in combination with lithium or sodium valproate; AND
The treatment must be maintenance therapy.Compliance with Authority Required procedures - Streamlined Authority Code 5912 C5916 P5916 Severe behavioural disturbances
Patient must have autism; AND
The treatment must be under the supervision of a paediatrician or psychiatrist; AND
The treatment must be in combination with non-pharmacological measures.
Patient must be under 18 years of age.
Behaviour disturbances are defined as severe aggression and injuries to self or others where non-pharmacological methods alone have been unsuccessful.
The diagnosis of autism must be made based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or ICD-10 international classification of mental and behavioural disorders.Compliance with Authority Required procedures - Streamlined Authority Code 5916 [139]Schedule 4, Part 1, after entry for Rotigotine
insert:
Ruxolitinib C5917 P5917 High risk and intermediate-2 risk myelofibrosis
Continuing treatment
The condition must be primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition.Compliance with Written or Telephone Authority Required procedures C5918 P5918 High risk and intermediate-2 risk myelofibrosis
Initial treatment
The condition must be primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.
Compliance with Written Authority Required procedures C5919 P5919 High risk, intermediate-2 risk and intermediate-1 risk myelofibrosis
Grandfathering treatment
The condition must be primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis; AND
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition before 1 February 2016.Compliance with Written Authority Required procedures C5920 P5920 Intermediate-1 risk myelofibrosis
Continuing treatment
The condition must be primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition.Compliance with Written or Telephone Authority Required procedures C5921 P5921 Intermediate-1 risk myelofibrosis
Initial treatment
The condition must be primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis; AND
Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy.Compliance with Written Authority Required procedures [140]Schedule 4, Part 1, entry for Thalidomide
substitute:
Thalidomide C5909 Where the patient is receiving treatment at/from a private hospital
Multiple myeloma
Compliance with Written or Telephone Authority Required procedures C5914 Where the patient is receiving treatment at/from a public hospital
Multiple myeloma
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5914 [141]Schedule 4, Part 1, entry for Ticarcillin with Clavulanic Acid
(a)omit:
C5831 Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent (b)insert in numerical order after existing text:
C5905 Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent [142]Schedule 5
insert as first item:
| Esomeprazole | GRP-17188 | Capsule (enteric) 20 mg (as magnesium) | Oral | Esomeprazole ACTAVIS Noxicid Caps |
| Tablet (enteric coated) 20 mg (as magnesium trihydrate) | Oral | Esomeprazole AN Esomeprazole Apotex Esomeprazole GH Esomeprazole GxP Esomeprazole RBX Esomeprazole Sandoz Nexium Nexole | ||
| GRP-17061 | Capsule (enteric) 40 mg (as magnesium) | Oral | Esomeprazole ACTAVIS Noxicid Caps | |
| Tablet (enteric coated) 40 mg (as magnesium trihydrate) | Oral | Esomeprazole AN Esomeprazole Apotex Esomeprazole GH Esomeprazole GxP Esomeprazole RBX Esomeprazole Sandoz Nexium Nexole |
[143]Schedule 5, entry for Rizatriptan, GRP-17623, in the form Tablet (orally disintegrating) 10 mg (as benzoate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Rizatriptan ODT GH |
0
0
0