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Prepared by the Office of Parliamentary Counsel, Canberra National Health (Originator Brand) Determination 2015 (PB 100 of 2015) made under subsection 99ADB(6B) of the National Health Act 1953 Compilation No. 40 Compilation date: 1 October 2020 Includes amendments up to: PB 96 of 2020 Registered: 8 October 2020 Authorised Version F2020C00906 registered 08/10/2020

National Health (Originator Brand) Determination 2015 (PB

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Prepared by the Office of Parliamentary Counsel, Canberra

National Health (Originator Brand)

Determination 2015 (PB 100 of 2015)

made under subsection 99ADB(6B) of the

National Health Act 1953

Compilation No. 40

Compilation date: 1 October 2020

Includes amendments up to: PB 96 of 2020

Registered: 8 October 2020

Authorised Version F2020C00906 registered 08/10/2020

About this compilation

This compilation

This is a compilation of the National Health (Originator Brand) Determination 2015 (PB 100

of 2015) that shows the text of the law as amended and in force on 1 October 2020 (the

compilation date).

The notes at the end of this compilation (the endnotes) include information about amending

laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any

uncommenced amendments affecting the law are accessible on the Legislation Register

(www.legislation.gov.au). The details of amendments made up to, but not commenced at, the

compilation date are underlined in the endnotes. For more information on any uncommenced

amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an

application, saving or transitional provision that is not included in this compilation, details are

included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the

modification does not amend the text of the law. Accordingly, this compilation does not show

the text of the compiled law as modified. For more information on any modifications, see the

series page on the Legislation Register for the compiled law.

Self-repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the

law, details are included in the endnotes.

Authorised Version F2020C00906 registered 08/10/2020

National Health (Originator Brand) Determination 2015 (PB 100 of 2015) i

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Contents 1 Name of Determination ............................................................................................... 1 3 Definition .................................................................................................................... 1 4 Originator Brand ......................................................................................................... 1

Schedule 1—Originator Brand 2

Endnotes 32

Endnote 1—About the endnotes 32

Endnote 2—Abbreviation key 33

Endnote 3—Legislation history 34

Endnote 4—Amendment history 36

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Section 1

National Health (Originator Brand) Determination 2015 (PB 100 of 2015) 1

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

1 Name of Determination

(1) This Determination is the National Health (Originator Brand)

Determination 2015.

(2) This Determination may also be cited as PB 100 of 2015.

3 Definition

In this Determination:

Act means the National Health Act 1953.

4 Originator Brand

(1) For subsection 99ADB(6B) of the Act, unless subsections (2) or (3) of this

section apply, an originator brand specified in column 3 of an item in Schedule 1

is an originator brand for all brands of pharmaceutical item containing the drug

specified in column 2 of the same item in Schedule 1.

(2) Where a manner of administration is specified in column 4 of an item in

Schedule 1, an originator brand specified in column 3 of that item in Schedule 1

is an originator brand for all brands of pharmaceutical item containing the drug

specified in column 1, with the manner of administration specified in column 4

of the same item in Schedule 1.

(3) Where a form is specified in column 5 of an item in Schedule 1, an originator

brand specified in column 3 of that item in Schedule 1 is an originator brand for

all brands of pharmaceutical item containing the drug specified in column 2, with

the manner of administration specified in column 4 in the form specified in

column 5 of the same item in Schedule 1.

Note: A brand of an exempt item is not an originator brand due to section 99ADA of the Act.

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Schedule 1 Originator Brand

2 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Schedule 1—Originator Brand (section 4)

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

1 Abacavir with Lamivudine Kivexa

1A Abatacept Orencia

Orencia Clickject

1B Acamprosate Campral

1C Acarbose Glucobay 50

Glucobay 100

1D Aciclovir Zovirax

Zovirax 200 mg

Zovirax 800 mg

2 Acitretin Neotigason

3 Adefovir Hepsera

3A Adrenaline (epinephrine) EpiPen

EpiPen Jr.

4 Alendronic acid with colecalciferol Fosamax Plus

Fosamax Plus 70 mg/140 mcg

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National Health (Originator Brand) Determination 2015 (PB 100 of 2015) 3

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

5 Alendronic acid with colecalciferol

and calcium

Fosamax Plus D-Cal

6 Allopurinol Zyloprim

7 Aluminium Hydroxide with

Magnesium Hydroxide

Mylanta P

8 Amiodarone Cordarone X 100

Cordarone X 200

9 Amisulpride Solian 100

Solian 200

Solian 400

10 Amlodipine Norvasc

11 Amlodipine with Atorvastatin Caduet 5/10

Caduet 5/20

Caduet 5/40

Caduet 5/80

Caduet 10/10

Caduet 10/20

Caduet 10/40

Caduet 10/80

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Schedule 1 Originator Brand

4 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

12 Amlodipine with valsartan Exforge 5/80

Exforge 5/160

Exforge 5/320

Exforge 10/160

Exforge 10/320

13 Amlodipine with valsartan and

hydrochlorothiazide

Exforge HCT 5/160/12.5

Exforge HCT 5/160/25

Exforge HCT 10/160/12.5

Exforge HCT 10/160/25

Exforge HCT 10/320/25

14 Amoxicillin Amoxil

Amoxil Forte

15 Amoxicillin with clavulanic acid Augmentin

Augmentin Duo

Augmentin Duo 400

Augmentin Duo forte

16 Anastrozole Arimidex

16A Apomorphine Apomine

Apomine Intermittent

Apomine Solution for Infusion

16B Aripiprazole Abilify Oral

Abilify Maintena Injection

16C Atazanavir Reyataz

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Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

17 Atenolol Tenormin

17A Atomoxetine Strattera

18 Atorvastatin Lipitor

18A Azacitidine Vidaza

19 Azathioprine Imuran

20 Azithromycin Zithromax

21 Baclofen Lioresal Intrathecal

Lioresal 10

Lioresal 25

22 Betamethasone Diprosone Application

Celestone Chronodose Injection

23 Betaxolol Betoptic

Betoptic S

24 Bicalutamide Cosudex

24A Bimatoprost Lumigan

Lumigan PF

25 Bisoprolol Bicor

25A Bivalirudin Angiomax

25B Bosentan Tracleer

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Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

26 Brimonidine Alphagan

Alphagan P 1.5

27 Brinzolamide Azopt

28 Bromocriptine Parlodel

28A Budesonide with formoterol Symbicort Rapihaler 50/3

Symbicort Rapihaler 100/3

Symbicort Rapihaler 200/6

Symbicort Turbuhaler 100/6

Symbicort Turbuhaler 200/6

Symbicort Turbuhaler 400/12

28B Buprenorphine Buvidal Monthly

Buvidal Weekly

Injection

Subutex Sublingual

Norspan Transdermal

29 Bupropion Zyban

30 Cabergoline Cabaser

Dostinex

30A Calcipotriol with betamethasone Daivobet

Daivobet 50/500 gel

31 Calcitriol Rocaltrol

32 Candesartan Atacand

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Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

33 Candesartan with

Hydrochlorothiazide

Atacand Plus 16/12.5

Atacand Plus 32/12.5

Atacand Plus 32/25

34 Capecitabine Xeloda

35 Captopril Capoten

36 Carbamazepine Tegretol 100

Tegretol 200

Tegretol CR 200

Tegretol CR 400

37 Carbomer Viscotears

Viscotears Gel PF

38 Carvedilol Dilatrend 3.125

Dilatrend 6.25

Dilatrend 12.5

Dilatrend 25

39 Cefaclor Ceclor

Ceclor CD

39A Cefalexin Keflex

39B Cefuroxime Zinnat

40 Celecoxib Celebrex

41 Certolizumab pegol Cimzia

41A Chorionic gonadotrophin Pregnyl

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8 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

41B Ciclosporin Neoral 25

Neoral 50

Neoral 100

42 Ciprofloxacin Ciproxin 250

Ciproxin 500

Oral

Ciloxan Application to the eye

43 Citalopram Cipramil

44 Clarithromycin Klacid

45 Clindamycin Dalacin C

46 Clomifene Clomid

47 Clomipramine Anafranil 25

48 Clonazepam Rivotril

48A Clonidine Catapres 100

Catapres

49 Clopidogrel Iscover

Plavix

50 Clopidogrel with aspirin CoPlavix

DuoCover

51 Clozapine Clozaril 25

Clozaril 100

52 Codeine with Paracetamol Panadeine Forte

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Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

53 Colchicine Colgout

55 Cyproterone Androcur

Androcur-100

56 Desferrioxamine Desferal 500 mg

57 Desvenlafaxine Pristiq

58 Dexamethasone Maxidex Application to the Eye

Ozurdex Implantation

59 Dexamethasone with Framycetin

and Gramicidin

Sofradex

60 Diazepam Valium

61 Diclofenac Voltaren 25

Voltaren 50

62 Digoxin Lanoxin–PG

Lanoxin

63 Diltiazem Cardizem

Cardizem CD

64 Diphenoxylate with Atropine Lomotil

65 Dipyridamole with Aspirin Asasantin SR

66 Docetaxel Taxotere

67 Donepezil Aricept

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Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

68 Dorzolamide Trusopt

69 Dorzolamide with timolol Cosopt

70 Doxorubicin – Pegylated

Liposomal

Caelyx

71 Duloxetine Cymbalta

71A Dutasteride Avodart

71B Dutasteride with tamsulosin Duodart 500ug/400ug

72 Electrolyte Replacement, Oral Repalyte New Formulation

73 Enalapril Renitec

Renitec 20

74 Enalapril with Hydrochlorothiazide Renitec Plus 20/6

74A Enoxaparin Clexane

Clexane Safety-Lock

74B Entecavir Baraclude

74C Eplerenone Inspra

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Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

75 Epoprostenol Flolan

Flolan Kit

76 Eprosartan Teveten

77 Escitalopram Lexapro

78 Esomeprazole Nexium

78A Esomeprazole and clarithromycin

and amoxicillin

Nexium Hp7

78B Estradiol Progynova

78C Etanercept Enbrel

79 Etoposide Vepesid Oral

Etopophos Injection

79A Everolimus Afinitor

Certican

80 Exemestane Aromasin

80A Ezetimibe Ezetrol

80B Ezetimibe and rosuvastatin Rosuzet Composite Pack

80C Ezetimibe with atorvastatin Atozet

80D Ezetimibe with simvastatin Vytorin

81 Famciclovir Famvir

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12 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

82 Felodipine Plendil ER

82A Fenofibrate Lipidil

83 Fentanyl Abstral Sublingual

Actiq Buccal

Durogesic 12

Durogesic 25

Durogesic 50

Durogesic 75

Durogesic 100

Transdermal

84 Filgrastim Neupogen

85 Flecainide Tambocor

86 Fluconazole Diflucan

87 Fludarabine Fludara

88 Fluoxetine Prozac 20

Prozac Tab

88A Fluticasone propionate Flixotide

Flixotide Accuhaler

Flixotide Junior

Flixotide Junior Accuhaler

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Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

88B Fluticasone propionate with

salmeterol

Seretide Accuhaler 100/50

Seretide Accuhaler 250/50

Seretide Accuhaler 500/50

Seretide MDI 50/25

Seretide MDI 125/25

Seretide MDI 250/25

89 Fluvastatin Lescol XL

90 Fluvoxamine Luvox

91 Folinic acid Leucovorin Calcium (Hospira Pty

Limited)

91A Follitropin Alfa Gonal-f Pen

92 Fosinopril Monopril

93 Fosinopril with

Hydrochlorothiazide

Monoplus 10/12.5

Monoplus 20/12.5

94 Furosemide Lasix

Lasix-M

95 Gabapentin Neurontin

96 Galantamine Reminyl

96A Ganciclovir Cymevene

96B Gefitinib Iressa

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14 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

97 Gentamicin Genoptic

98 Glibenclamide Daonil

99 Gliclazide Diamicron 60mg MR

100 Glimepiride Amaryl

101 Glipizide Minidiab

102 Glucose Baxter Healthcare Pty Ltd

103 Glyceryl Trinitrate Anginine

Stabilised

Buccal/sublingual

Transiderm-Nitro 25

Transiderm-Nitro 50

Nitro-Dur 5

Nitro-Dur 10

Nitro-Dur 15

Transdermal

104 Granisetron Kytril

105 Hydrochlorothiazide with

Amiloride

Moduretic

106 Hydrocortisone

Solu-Cortef Injection

Hycor Application to the eye

106A Hydromorphone Dilaudid

Dilaudid-HP

Injection

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Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

Dilaudid

Jurnista

Oral

106B Hydroxycarbamide Hydrea

107 Hydroxychloroquine Plaquenil

107A Hyoscine Buscopan

108 Hypromellose with Carbomer 980 Genteal gel

109 Hypromellose with Dextran Tears Naturale

109A Ibuprofen Brufen

109B Icatibant Firazyr

110 Idarubicin Zavedos

Zavedos Solution

110A Imatinib Glivec

111 Imipramine Tofranil 10

Tofranil 25

112 Imiquimod Aldara

Aldara Pump

113 Indapamide Natrilix

Natrilix SR

114 Indometacin Indocid

114A Infliximab Remicade

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16 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

114B Insulin glargine Lantus

Lantus SoloStar

Toujeo SoloStar

115 Interferon Beta-1b Betaferon

116 Ipratropium Atrovent

Atrovent Adult

117 Irbesartan Avapro

Karvea

118 Irbesartan with

Hydrochlorothiazide

Avapro HCT

150/12.5

Avapro HCT

300/12.5

Avapro HCT

300/25

Karvezide

150/12.5

Karvezide

300/12.5

Karvezide

300/25

119 Isosorbide Dinitrate Isordil Sublingual

120 Isosorbide Mononitrate Imdur Durule

Imdur 120 mg

121 Isotretinoin Roaccutane

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Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

121A Itraconazole Sporanox

Lozanoc

121B Ivabradine Coralan

122 Ketoprofen Orudis SR 200

123 Labetalol Trandate

124 Lamivudine Zeffix

3TC

125 Lamivudine with Zidovudine Combivir

126 Lamotrigine Lamictal

127 Lansoprazole Zoton FasTabs

128 Latanoprost Xalatan

129 Latanoprost with timolol Xalacom

130 Leflunomide Arava

131 Lercanidipine Zanidip

132 Letrozole Femara 2.5 mg

133 Levetiracetam Keppra

134 Levodopa with Carbidopa Sinemet

Sinemet 100/25

Oral

Duodopa Intra-intestinal

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Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

134A Levodopa with carbidopa and

entacapone

Stalevo 50/12.5/200mg

Stalevo 75/18.75/200mg

Stalevo 100/25/200mg

Stalevo 125/31.25/200mg

Stalevo 150/37.5/200mg

Stalevo 200/50/200mg

135 Levonorgestrel with

ethinyestradiol

Microgynon 50 ED Oral Pack containing 21 tablets

125 micrograms-50

micrograms and 7 inert

tablets

Microgynon 30 ED

Nordette 28

Oral Pack containing 21 tablets

150 micrograms-30

micrograms and 7 inert

tablets

Triphasil 28

Triquilar ED

Oral Pack containing 6 tablets

50 micrograms-30

micrograms, 5 tablets

75 micrograms-40

micrograms, 10 tablets

125 micrograms-30

micrograms and 7 inert

tablets

135A Levothyroxine Oroxine

135B Lincomycin Lincocin

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Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

136 Lisinopril Zestril

Prinivil 10

Prinivil 20

137 Loperamide Imodium

138 Losartan Cozavan

138A Lurasidone Latuda

139 Macrogol 3350 Movicol Liquid

Movicol

140 Medroxyprogesterone Provera

Depo-Provera

141 Meloxicam Mobic

142 Memantine Ebixa

142A Mercaptopurine Purinethol

143 Metformin Diabex

Diabex 850

Diabex 1000

Diabex XR 500

Diabex XR 1000

144 Methadone Physeptone

145 Methyldopa Aldomet

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Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

146 Methylphenidate Ritalin 10

Ritalin LA

147 Methylprednisolone Depo-Medrol

Solu-Medrol

148 Metoclopramide Maxolon

149 Metoprolol Betaloc

Lopresor 50

Lopresor 100

150 Metoprolol succinate Toprol-XL 23.75

Toprol-XL 47.5

Toprol-XL 95

Toprol-XL 190

151 Metronidazole Flagyl

152 Minocycline Minomycin-50

153 Moclobemide Aurorix

Aurorix 300 mg

153A Modafinil Modavigil

154 Mometasone Elocon

Elocon Alcohol Free

155 Montelukast Singulair

156 Morphine DBL Morphine Sulfate

Pentahydrate

Injection

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Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

MS Contin

MS Contin Suspension 100 mg

MS Contin Suspension 20 mg

MS Contin Suspension 200 mg

MS Contin Suspension 30 mg

MS Contin Suspension 60 mg

156A Moxonidine Physiotens

157 Mycophenolic Acid Myfortic

CellCept

157A Naloxone Naloxone Hydrochloride (DBL) Injection

Nyxoid Nasal

158 Naltrexone ReVia

159 Naproxen Naprosyn

Naprosyn SR750

Naprosyn SR1000

159A Nebivolol Nebilet

160 Nevirapine Viramune

Viramune XR

161 Nicorandil Ikorel

162 Nifedipine Adalat 10

Adalat 20

Adalat Oros 20mg

Adalat Oros 30

Adalat Oros 60

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Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

163 Nitrazepam Mogadon

163A Nitrofurantoin Macrodantin

164 Nizatidine Tazac

165 Norethisterone Micronor

Noriday 28 day

Primolut N

166 Norethisterone with

ethinylestradiol

Brevinor

Brevinor-1

166A Nortriptyline Allegron

167 Octreotide Sandostatin 0.05

Sandostatin 0.1

Sandostatin 0.5

Sandostatin LAR

169 Olanzapine Zyprexa

Zyprexa Zydis

Zyprexa Relprevv

170 Olmesartan Olmetec

170A Olmesartan with amlodipine Sevikar 20/5

Sevikar 40/5

Sevikar 40/10

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Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

170B Olmesartan with amlodipine and

hydrochlorothiazide

Sevikar HCT 20/5/12.5

Sevikar HCT 40/10/12.5

Sevikar HCT 40/10/25

Sevikar HCT 40/5/12.5

Sevikar HCT 40/5/25

170C Olmesartan with

hydrochlorothiazide

Olmetec Plus

171 Omalizumab Xolair

172 Omeprazole Losec Tablets

173 Ondansetron Zofran

Zofran Zydis

174 Oxaliplatin Eloxatin

175 Oxazepam Serepax

176 Oxybutynin Ditropan

177 Oxycodone Endone

OxyNorm

OxyContin

Oral

Proladone Rectal

178 Pamidronic Acid Aredia 30 mg

Aredia 90 mg

179 Pantoprazole Somac

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Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

180 Paracetamol Panadol Osteo

181 Paroxetine Aropax

181A Pegfilgrastim Neulasta

181B Pemetrexed Alimta

182 Perindopril Coversyl 2.5mg

Coversyl 5mg

Coversyl 10mg

183 Perindopril with amlodipine Coveram 5/5

Coveram 5/10

Coveram 10/5

Coveram 10/10

184 Perindopril with indapamide Coversyl Plus LD 2.5mg/0.625mg

Coversyl Plus 5mg/1.25mg

185 Pindolol Visken 15

186 Pioglitazone Actos

187 Piroxicam Feldene

Feldene-D

188 Polyvinyl Alcohol Liquifilm Tears

189 Pramipexole Sifrol

Sifrol ER

190 Pravastatin Pravachol

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National Health (Originator Brand) Determination 2015 (PB 100 of 2015) 25

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

191 Prazosin Minipress

191A Pregabalin Lyrica

192 Prochlorperazine Stemetil

193 Propranolol Inderal

194 Quetiapine Seroquel

Seroquel XR

195 Quinapril Accupril

196 Rabeprazole Pariet

197 Raloxifene Evista

198 Ramipril Tritace

Tritace 1.25 mg

Tritace 2.5 mg

Tritace 5 mg

Tritace 10 mg

Tritace Titration Pack

199 Ranitidine Zantac

199A Rasagiline Azilect

200 Riluzole Rilutek

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Schedule 1 Originator Brand

26 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

201 Risedronic Acid Actonel

Actonel EC

Actonel Once-a-Month

202 Risedronic Acid and Calcium Actonel EC Combi

203 Risedronic acid and calcium with

colecalciferol

Actonel EC Combi D

204 Risperidone Risperdal

Risperdal Quicklet

Risperdal Consta

204A Rituximab Mabthera

Mabthera SC

204B Rivastigmine

Exelon Oral

Exelon Patch 5

Exelon Patch 10

Exelon Patch 15

Transdermal

204C Rizatriptan Maxalt

205 Rosuvastatin Crestor

206 Roxithromycin Rulide

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Originator Brand Schedule 1

National Health (Originator Brand) Determination 2015 (PB 100 of 2015) 27

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

207 Salbutamol Ventolin Rotacaps

Ventolin CFC-free

Ventolin CFC-Free with dose

counter

Ventolin Nebules

208 Selegiline Eldepryl

209 Sertraline Zoloft

209A Sevelamer Renagel

210 Sildenafil Revatio

211 Simvastatin Lipex 10

Lipex 20

Lipex 40

Lipex 80

Zocor

211A Somatropin Genotropin

Genotropin GoQuick

Genotropin MiniQuick

212 Sorbitol with sodium citrate

dihydrate and sodium lauryl

sulfoacetate

Microlax

213 Sotalol Sotacor

214 Spironolactone Aldactone

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Schedule 1 Originator Brand

28 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

215 Sucralfate Carafate

216 Sulfasalazine Salazopyrin

Salazopyrin-EN

217 Sumatriptan Imigran

Imigran FDT

218 Tacrolimus Prograf

Prograf XL

218A Tadalafil Adcirca

219 Tamoxifen Nolvadex-D

220 Telmisartan Micardis

221 Telmisartan with amlodipine Twynsta

222 Telmisartan with

Hydrochlorothiazide

Micardis Plus 40/12.5 mg

Micardis Plus 80/12.5 mg

Micardis Plus 80/25 mg

223 Temazepam Normison

224 Temozolomide Temodal

224A Tenofovir Viread

224B Tenofovir with emtricitabine Truvada

224C Tenofovir with emtricitabine and

efavirenz

Atripla

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Originator Brand Schedule 1

National Health (Originator Brand) Determination 2015 (PB 100 of 2015) 29

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

225 Terbinafine Lamisil (Novartis Pharmaceuticals

Australia Pty Limited)

225A Teriflunomide Aubagio

227 Timolol Timoptol

Timoptol XE

228 Tinidazole Fasigyn

228A Tiotropium Spiriva

Spiriva Respimat

229 Tirofiban Aggrastat

229A Tobramycin DBL Tobramycin

Pfizer Australia Pty Ltd

Injection

Tobi Inhalation

TOBI podhaler Inhalation by mouth

Tobrex Application to the eye

229B Tocilizumab Actemra

Actemra ACTPen

Actemra Subcutaneous Injection

230 Topiramate Topamax

Topamax Sprinkle

231 Topotecan Hycamtin

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Schedule 1 Originator Brand

30 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

232 Tramadol

Tramal

Tramal SR 50

Tramal SR 100

Tramal SR 150

Tramal SR 200

Tramal 100

233 Trandolapril Gopten

233A Tranexamic Acid Cyklokapron

233B Trastuzumab Herceptin

Herceptin SC

234 Triamcinolone Kenacort-A10 Injection

Aristocort 0.02% Application

235 Triamcinolone with Neomycin,

Gramicidin and Nystatin

Kenacomb Otic

236 Trimethoprim Triprim

237 Trimethoprim with

Sulfamethoxazole

Bactrim

Bactrim DS

238 Ursodeoxycholic Acid Ursofalk

239 Valaciclovir Valtrex

239A Valganciclovir Valcyte

240 Valproic Acid Epilim EC

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National Health (Originator Brand) Determination 2015 (PB 100 of 2015) 31

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Column 1 Column 2 Column 3 Column 4 Column 5

Item Drug Originator Brand Manner of

administration Form

241 Valsartan Diovan

242 Valsartan with

hydrochlorothiazide

Co-Diovan 80/12.5

Co-Diovan 160/12.5

Co-Diovan 160/25

Co-Diovan 320/12.5

Co-Diovan 320/25

243 Vancomycin

Vancocin

Vancocin CP

244 Venlafaxine Efexor-XR

245 Verapamil Isoptin

Isoptin SR

Isoptin 180 SR

246 Vinorelbine Navelbine

246A Voriconazole Vfend

247 Ziprasidone Zeldox

247A Zoledronic acid Aclasta

Zometa

248 Zolmitriptan Zomig

248A Zonisamide Zonegran

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Endnotes

Endnote 1—About the endnotes

32 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or

will amend) the compiled law. The information includes commencement details for amending

laws and details of any application, saving or transitional provisions that are not included in

this compilation.

The amendment history in endnote 4 provides information about amendments at the provision

(generally section or equivalent) level. It also includes information about any provision of the

compiled law that has been repealed in accordance with a provision of the law.

Editorial changes

The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and

presentational changes to a compiled law in preparing a compilation of the law for

registration. The changes must not change the effect of the law. Editorial changes take effect

from the compilation registration date.

If the compilation includes editorial changes, the endnotes include a brief outline of the

changes in general terms. Full details of any changes can be obtained from the Office of

Parliamentary Counsel.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the

amendment to be made. If, despite the misdescription, the amendment can be given effect as

intended, the amendment is incorporated into the compiled law and the abbreviation “(md)”

added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not

incorp)” is added to the details of the amendment included in the amendment history.

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Endnotes

Endnote 2—Abbreviation key

National Health (Originator Brand) Determination 2015 (PB 100 of 2015) 33

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Endnote 2—Abbreviation key

ad = added or inserted o = order(s)

am = amended Ord = Ordinance

amdt = amendment orig = original

c = clause(s) par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x /sub-subparagraph(s)

Ch = Chapter(s) pres = present

def = definition(s) prev = previous

Dict = Dictionary (prev…) = previously

disallowed = disallowed by Parliament Pt = Part(s)

Div = Division(s) r = regulation(s)/rule(s)

ed = editorial change reloc = relocated

exp = expires/expired or ceases/ceased to have renum = renumbered

effect rep = repealed

F = Federal Register of Legislation rs = repealed and substituted

gaz = gazette s = section(s)/subsection(s)

LA = Legislation Act 2003 Sch = Schedule(s)

LIA = Legislative Instruments Act 2003 Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given SLI = Select Legislative Instrument

effect SR = Statutory Rules

(md not incorp) = misdescribed amendment Sub-Ch = Sub-Chapter(s)

cannot be given effect SubPt = Subpart(s)

mod = modified/modification underlining = whole or part not

No. = Number(s) commenced or to be commenced

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Endnotes

Endnote 3—Legislation history

34 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Endnote 3—Legislation history

Name Registration Commencement Application, saving

and transitional

provisions

PB 100 of 2015 29 Sept 2015

(F2015L01525)

1 Oct 2015 (s 2)

PB 114 of 2015 1 Dec 2015

(F2015L01905)

1 Dec 2015 (s 2) —

PB 127 of 2015 24 Dec 2015

(F2015L02140)

1 Jan 2015 (s 2) —

PB 8 of 2016 1 Feb 2016

(F2016L00083)

1 Feb 2016 (s 2) —

PB 27 of 2016 1 Apr 2016

(F2016L00471)

1 Apr 2016 (s 2) —

PB 38 of 2016 29 Apr 2016

(F2016L00606)

1 May 2016 (s 2) —

PB 49 of 2016 31 May 2016

(F2016L00869)

1 June 2016 (s 2) —

PB 71 of 2016 28 July 2016

(F2016L01245)

1 Aug 2016 (s 2) —

PB 79 of 2016 25 Aug 2016

(F2016L01329)

1 Sept 2016 (s 2) —

PB 89 of 2016 28 Sept 2016

(F2016L01537)

1 Oct 2016 (s 2) —

PB 105 of 2016 30 Nov 2016

(F2016L01840)

1 Dec 2016 (s 2) —

PB 11 of 2017 27 Jan 2017

(F2017L00078)

1 Feb 2017 (s 2) —

PB 23 of 2017 30 Mar 2017

(F2017L00360)

1 Apr 2017 (s 2) —

PB 33 of 2017 28 Apr 2017

(F2017L00487)

1 May 2017 (s 2) —

PB 42 of 2017 31 May 2017

(F2017L00632)

1 June 2017 (s 2) —

PB 50 of 2017 29 June 2017

(F2017L00823)

1 July 2017 (s 2) —

PB 61 of 2017 27 July 2017

(F2017L00962)

1 Aug 2017 (s 2) —

PB 80 of 2017 29 Sept 2017

(F2017L01307)

1 Oct 2017 (s 2) —

PB 98 of 2017 29 Nov 2017

(F2017L01550)

1 Dec 2017 (s 2) —

PB 11 of 2018 30 Jan 2018

(F2018L00061)

1 Feb 2018 (s 2) —

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Endnotes

Endnote 3—Legislation history

National Health (Originator Brand) Determination 2015 (PB 100 of 2015) 35

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Name Registration Commencement Application, saving

and transitional

provisions

PB 26 of 2018 28 Mar 2018

(F2018L00419)

1 Apr 2018 (s 2) —

PB 44 of 2018 31 May 2018

(F2018L00696)

1 June 2018 (s 2) —

PB 60 of 2018 29 June 2018

(F2018L00957)

1 July 2018 (s 2) —

PB 71 of 2018 1 Aug 2018

(F2018L01073)

1 Aug 2018 (s 2) —

PB 88 of 2018 27 Sept 2018

(F2018L01351)

1 Oct 2018 (s 2) —

PB 105 of 2018 29 Nov 2018

(F2018L01635)

1 Dec 2018 (s 2) —

PB 6 of 2019 31 Jan 2019

(F2019L00079)

1 Feb 2019 (s 2) —

PB 25 of 2019 29 Mar 2019

(F2019L00467)

1 Apr 2019 (s 2) —

PB 34 of 2019 30 Apr 2019

(F2019L00657)

1 May 2019 (s 2) —

PB 42 of 2019 31 May 2019

(F2019L00715)

1 June 2019 (s 2) —

PB 64 of 2019 30 July 2019

(F2019L01017)

1 Aug 2019 (s 2) —

PB 73 of 2019 30 Aug 2019

(F2019L01121)

1 Sept 2019 (s 2) —

PB 82 of 2019 30 Sept 2019

(F2019L01292)

1 Oct 2019 (s 2) —

PB 90 of 2019 31 Oct 2019

(F2019L01396)

1 Nov 2019 (s 2) —

PB 99 of 2019 27 Nov 2019

(F2019L01512)

1 Dec 2019 (s 2) —

PB 9 of 2020 31 Jan 2020

(F2020L00077)

1 Feb 2020 (s 2) —

PB 27 of 2020 31 Mar 2020

(F2020L00362)

1 Apr 2020 (s 2) —

PB 49 of 2020 29 May 2020

(F2020L00640)

1 June 2020 (s 2) —

PB 74 of 2020 31 July 2020

(F2020L00970)

1 Aug 2020 (s 2) —

PB 85 of 2020 28 Aug 2020

(F2020L01086)

1 Sept 2020 (s 2(1) item 1) —

PB 96 of 2020 30 Sept 2020

(F2020L01257)

1 Oct 2020 (s 2(1) item 1) —

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Endnotes

Endnote 4—Amendment history

36 National Health (Originator Brand) Determination 2015 (PB 100 of 2015)

Compilation No. 40 Compilation date: 01/10/2020 Registered: 08/10/2020

Endnote 4—Amendment history

Provision affected How affected

s 2 .................................................. rep LIA s 48D

Schedule 1

Schedule 1 ..................................... am PB 114 and 127 of 2015; PB 8, 27, 38, 49, 71, 79, 89 and 105 of 2016; PB 11 of 2017;

PB 23 of 2017; PB 33 of 2017; PB 42 of 2017; PB 50 of 2017; PB 61 of 2017; PB 80 of

2017; PB 98 of 2017; PB 11 of 2018; PB 26 of 2018

ed C20

am PB 44 of 2018

ed C21

am PB 60 of 2018; PB 71 of 2018; PB 88 of 2018; PB 105 of 2018; PB 6 of 2019; PB 25 of

2019; PB 34 of 2019; PB 42 of 2019; PB 64 of 2019; PB 73 of 2019; PB 82 of 2019; PB 90

of 2019; PB 99 of 2019; PB 9 of 2020; PB 27 of 2020; PB 49 of 2020; PB 74 of 2020; PB 85

of 2020; PB 96 of 2020

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