PB 100 of 2015

National Health (Originator Brand) Determination 2015

National Health Act 1953

I, KYLIE JONASSON, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Determination under subsection 99ADB (6B) of the National Health Act 1953.

Dated             24   September 2015

 

 

 

 

 

 

_____________________________________

KYLIE JONASSON

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

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.

2 Commencement

  This Determination commences on 1 October 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.

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

Aciclovir

Zovirax

Zovirax 200 mg

Zovirax 800 mg

 

 

2

Acitretin

Neotigason

 

 

3

Adefovir

Hepsera

 

 

4

Alendronic acid with colecalciferol

Fosamax Plus

Fosamax Plus 70 mg/140 mcg

 

 

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

 

 

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

Amoxycillin

Amoxil

Amoxil Forte

 

 

15

Amoxycillin with Clavulanic Acid

Augmentin

Augmentin Duo

Augmentin Duo 400

Augmentin Duo forte

 

 

16

Anastrozole

Arimidex

 

 

17

Atenolol

Tenormin

 

 

18

Atorvastatin

Lipitor

 

 

19

Azathioprine

Imuran

 

 

20

Azithromycin

Zithromax

 

 

21

Baclofen

Lioresal 10

Lioresal 25

 

 

22

Betamethasone

 

 

Diprosone

Application

 

Celestone Chronodose

Injection

 

23

Betaxolol

Betoptic

Betoptic S

 

 

24

Bicalutamide

Cosudex

 

 

25

Bisoprolol

Bicor

 

 

26

Brimonidine

 

Alphagan

Alphagan P 1.5

 

 

27

Brinzolamide

Azopt

 

 

28

Bromocriptine

Parlodel

 

 

29

Bupropion

Zyban

 

 

30

Cabergoline

Cabaser

Dostinex

 

 

31

Calcitriol

Rocaltrol

 

 

32

Candesartan

Atacand

 

 

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

 

 

40

Celecoxib

Celebrex

 

 

41

Cephalexin

Keflex

 

 

42

Ciprofloxacin

 

Ciproxin 250

Ciproxin 500

Oral

 

Ciloxan

 

Application to the eye

43

Citalopram

Cipramil

 

 

44

Clarithrmycin

Klacid

 

 

45

Clindamycin

Dalacin C

 

 

46

Clomiphene

Clomid

 

 

47

Clomipramine

Anafranil 25

 

 

48

Clonazepam

Rivotril

 

 

49

Clopidogrel

Iscover

Plavix

 

 

50

Clopidogrel with aspirin

CoPlavix

DuoCover

 

 

51

Clozapine

Clozaril 25

Clozaril 100

 

 

52

Codeine with Paracetamol

Panadeine Forte

 

 

53

Colchicine

Colgout

 

 

54

Cyclosporin

Neoral 25

Neoral 50

Neoral 100

 

 

55

Cyproterone

Androcur

Androcur-100

 

 

56

Desferrioxamine

Desferal 500 mg

 

 

 

57

Desvenlafaxine

Pristiq

 

 

58

Dexamethasone

Maxidex

 

 

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

 

 

68

Dorzolamide

Trusopt

 

 

69

Dorzolamide with timolol

Cosopt

 

 

70

Doxorubicin – Pegylated Liposomal

Caelyx

 

 

71

Duloxetine

Cymbalta

 

 

72

Electrolyte Replacement, Oral

Repalyte New Formulation

 

 

73

Enalapril

Renitec

Renitec 20

 

 

74

Enalapril with Hydrochlorothiazide

Renitec Plus 20/6

 

 

75

Epoprostenol

Flolan Kit

 

 

76

Eprosartan

Teveten

 

 

77

Escitalopram

Lexapro

 

 

78

Esomeprazole

Nexium

 

 

79

Etoposide

Vepesid

Oral

 

Etopophos

Injection

80

Exemestane

Aromasin

 

 

81

Famciclovir

Famvir

 

 

82

Felodipine

Plendil ER

 

 

83

Fentanyl

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

 

 

89

Fluvastatin

Lescol XL

 

 

90

Fluvoxamine

Luvox

 

 

91

Folinic acid

Leucovorin Calcium (Hospira Pty Limited)

 

 

92

Fosinopril

Monopril

 

 

93

Fosinopril with Hydrochlorothiazide

Monoplus 10/12.5

Monoplus 20/12.5

 

 

94

Frusemide

Lasix

Lasix-M

 

 

95

Gabapentin

Neurontin

 

 

96

Galantamine

Reminyl

 

 

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

 

107

Hydroxychloroquine

Plaquenil

 

 

108

Hypromellose with Carbomer 980

Genteal gel

 

 

109

Hypromellose with Dextran

Tears Naturale

 

 

110

Idarubicin

Zavedos

Zavedos Solution

 

 

111

Imipramine

Tofranil 10

Tofranil 25

 

 

112

Imiquimod

Aldara

Aldara Pump

 

 

113

Indapamide

Natrilix

Natrilix SR

 

 

114

Indomethacin

Indocid

 

 

115

Interferon Beta1b

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

 

 

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

 

135

Levonorgestrel with Ethinyloestradiol

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

136

Lisinopril

Zestril

Prinivil 10

Prinivil 20

 

 

137

Loperamide

Imodium

 

 

138

Losartan

Cozavan

 

 

139

Macrogol 3350

Movicol Liquid

Movicol

 

 

140

Medroxyprogesterone

Provera

Depo-Provera

 

 

141

Meloxicam

Mobic

 

 

142

Memantine

Ebixa

 

 

143

Metformin

Diabex

Diabex 850

Diabex 1000

Diabex XR

Diabex XR 1000

 

 

144

Methadone

Physeptone

 

 

145

Methyldopa

Aldomet

 

 

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

 

 

154

Mometasone

Elocon

 

 

155

Montelukast

Singulair

 

 

156

Morphine

 

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

 

 

157

Mycophenolic Acid

Myfortic

CellCept

 

 

158

Naltrexone

ReVia

 

 

159

Naproxen

Naprosyn

Naprosyn SR750

Naprosyn SR1000

 

 

160

Nevirapine

Viramune

Viramune XR

 

 

161

Nicorandil

Ikorel

 

 

162

Nifedipine

Adalat 10

Adalat 20

Adalat Oros 20mg

Adalat Oros 30

Adalar Oros 60

 

 

163

Nitrazepam

Mogadon

 

 

164

Nizatidine

Tazac

 

 

165

Norethisterone

Micronor

Noriday 28 day

Primolut N

 

 

166

Norethisterone with Ethinyloestradiol

Brevinor

Brevinor-1

 

 

167

Octreotide

Sandostatin 0.05

Sandostatin 0.1

Sandostatin 0.5

Sandostatin LAR

 

 

168

Oestradiol

Progynova

 

Oral

 

169

Olanzapine

Zyprexa

Zyprexa Zydis

Zyprexa Relprevv

 

 

170

Olmesartan

Olmetec

 

 

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

 

 

180

Paracetamol

Panadol Osteo

 

 

181

Paroxetine

Aropax

 

 

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

 

 

191

Prazosin

Minipress

 

 

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

 

 

200

Riluzole

Rilutek

 

 

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

 

 

205

Rosuvastatin

Crestor

 

 

206

Roxithromycin

Rulide

 

 

207

Salbutamol

Ventolin Rotacaps

Ventolin CFC-free

Ventolin Nebules

 

 

208

Selegiline

Eldepryl

 

 

209

Sertraline

Zoloft

 

 

210

Sildenafil

Revatio

 

 

211

Simvastatin

Lipex 10

Lipex 20

Lipex 40

Lipex 80

Zocor

 

 

212

Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate

Microlax

 

 

213

Sotalol

Sotacor

 

 

214

Spironolactone

Aldactone

 

 

215

Sucralfate

Carafate

 

 

216

Sulfasalazine

Salazopyrin

Salazopyrin-EN

 

 

217

Sumatriptan

Imigran

Imigran FDT

 

 

218

Tacrolimus

Prograf

Prograf XL

 

 

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

 

 

225

Terbinafine

Lamisil (Novartis Pharmaceuticals Australia Pty Limited)

 

 

226

Thyroxine

Oroxine

 

 

227

Timolol

Timoptol

Timoptol XE

 

 

228

Tinidazole

Fasigyn

 

 

229

Tirofiban

Aggrastat

 

 

230

Topiramate

Topamax

Topamax Sprinkle

 

 

231

Topotecan

Hycamtin

 

 

232

 

Tramadol

 

Tramal

Tramal SR 50

Tramal SR 100

Tramal SR 150

Tramal SR 200

Tramal 100

 

 

233

Trandolapril

Gopten

 

 

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

Valciclovir

Valtrex

 

 

240

Valproic Acid

Epilim EC

 

 

241

Valsartan

Diovan

 

 

242

Valsartan with hydrochlorothiazide

Co-Diovan 80/12.5

Co-Diovan 160/12.5

Co-Diovan 160/25

Co-Diovan320/12.5

Co-Diovan 320/25

 

 

243

 

Vancomycin

 

Vancocin

Vancocin CP

 

 

244

Venlafaxine

Efexor-XR

 

 

245

Verapamil

Isoptin

Isoptin SR

Isoptin 180 SR

 

 

246

Vinorelbine

Navelbine

 

 

247

Ziprasidone

Zeldox

 

 

248

Zolmitriptan

Zomig