Untitled document

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

made under subsection 99ADB(6B) of the

National Health Act 1953

Compilation No. 10

Compilation date:   1 December 2016

Includes amendments up to:            PB 105 of 2016

Registered:   1 December 2016

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 December 2016 (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 ( 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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents

1............ Name of Determination................................................................................................. 2

3............ Definition...................................................................................................................... 2

4............ Originator Brand........................................................................................................... 2

Schedule 1—Originator Brand  3

Endnotes28

Endnote 1—About the endnotes  28

Endnote 2—Abbreviation key  29

Endnote 3—Legislation history  30

Endnote 4—Amendment history  31

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.

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	Acarbose	Glucobay 50 Glucobay 100
1A	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
16A	Apomorphine	Apomine
16B	Aripiprazole	Abilify	Oral
		Abilfy Maintena	Injection
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
25	Bisoprolol	Bicor
25A	Bivalirudin	Angiomax
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	Clarithromycin	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
74A	Entecavir	Baraclude
74B	Eplerenone	Inspra
75	Epoprostenol	Flolan Kit
76	Eprosartan	Teveten
77	Escitalopram	Lexapro
78	Esomeprazole	Nexium
78A	Esomeprazole and Clarithromycin and Amoxycillin	Nexium Hp7
79	Etoposide	Vepesid	Oral
		Etopophos	Injection
80	Exemestane	Aromasin
81	Famciclovir	Famvir
82	Felodipine	Plendil ER
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
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	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
110A	Imatinib	Glivec
111	Imipramine	Tofranil 10 Tofranil 25
112	Imiquimod	Aldara Aldara Pump
113	Indapamide	Natrilix Natrilix SR
114	Indomethacin	Indocid
114A	Infliximab	Remicade
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
121A	Itraconazole	Sporanox Lozanoc
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
153A	Modafinil	Modavigil
154	Mometasone	Elocon Elocon Alcohol Free
155	Montelukast	Singulair
156	Morphine	Hospira Pty Limited	Injection
		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
170A	Olmesartan with amlodipine	Sevikar 20/5 Sevikar 40/5 Sevikar 40/10
170B	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
180	Paracetamol	Panadol Osteo
181	Paroxetine	Aropax
181A	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
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
204A	Rivastigmine	Exelon	Oral
		Exelon Patch 5 Exelon Patch 10 Exelon Patch 15	Transdermal
204A	Rizatriptan	Maxalt
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
211A	Somatroptin	Genotropin Genotropin GoQuick Genotropin MiniQuick
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
229A	Tobramycin	Hospira Pty Limited Pfizer Australia Pty Ltd	Injection
		Tobi	Inhalation
		TOBI podhaler	Inhalation by mouth
		Tobrex	Application to the eye
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	Valaciclovir	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-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

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.

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

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)	—

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