Browse AusPARs by sponsor
Australian Public Assessment Reports for prescription medicines
29 April 2013
An Australian Public Assessment Report for prescription medicines (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application. More information about AusPARs.
The sponsor is the person or company responsible for applying to the TGA to have their medicine included in the Australian Register of Therapeutic Goods.
Please be aware that the AusPAR contains the Product Information for that prescription medicine at the time the TGA evaluated it. Product Information may have been updated since the AusPAR was prepared. For the current Product Information for a medicine please see: Product Information (PI).
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A - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Abbott Australasia Pty Ltd | Leuprorelin acetate | Lucrin Depot / Lucrin XL Depot | PM-2009-00544-3-4 | New strength, New route of administration | 30/07/2010 |
| Abbott Products Pty Ltd | Omega-3-acid ethyl esters 90 | Omacor | PM-2008-3043-3 | New chemical entity | 28/07/2010 |
| Abbott Products Pty Ltd | Pancreatic extract | Creon Micro | PM-2009-02729-3-1 | New formulation | 28/09/2010 |
| Accord Healthcare Pty Ltd | Alendronic acid | Alendraccord / Alendrocor / Pharmacor Alendronate | PM-2009-01135-3-5 | New generic | 16/02/2011 |
| Actelion Pharmaceuticals Australia | Bosentan | Tracleer | PM-2010-02897-3-4 | Major Variation, New Indication | 05/09/2012 |
| Actelion Pharmaceuticals Australia Pty Ltd | Miglustat | Zavesca | PM-2008-3187-1 | Extension of indications | 09/03/2010 |
| Alcon Laboratories (Australia) Pty Ltd | Brinzolamide / Timolol Maleate | Azarga | PM-2008-3124-5 | New fixed combination | 19/02/2010 |
| Allergan Australia Pty Ltd | Cyclosporin | Restasis | PM-2009-03746-3-5 | Extension of indications, New dosage form | 22/11/2011 |
| Allergan Australia Pty Ltd | Brimonidine tartrate | Alphagan P / Enidin P | PM-2008-03768-3-5 | New strength, Change in formulation, Two new trade names | 24/05/2010 |
| Allergan Australia Pty Ltd | Botulinum toxin type A | Botox | PM-2010-03508-3-3 | Extension of indications | 06/07/2012 |
| Allergan Australia Pty Ltd | Botulinum toxin type A | Botox | PM-2009-03219-3-1 | Extension of indications | 15/06/2011 |
| Allergan Australia Pty Ltd | Dexamethasone | Ozurdex | PM-2009-00795-3-5 | New dose form, New route of administration, Extension of indications | 19/10/2011 |
| Amgen Australia Pty Ltd | Denosumab | Prolia | PM-2009-00390-3-5 | New biological entity | 26/10/2010 |
| Amgen Australia Pty Ltd | Denosumab | Xgeva | PM-2010-02051-3-4 | New indication, New strength | 30/11/2011 |
| Amgen Australia Pty Ltd | Panitumumab | Vectibix | PM-2010-01972-3-4 | Major variation (extension of indications) | 07/05/2012 |
| Aspen Pharmacare Australia Pty Ltd | Filgrastim | Tevagrastim | PM-2009-1996-3-4 | Similar biological medicinal product | 17/10/2011 |
| AstraZeneca Pty Ltd | Budesonide / Eformoterol | Symbicort Rapihaler | PM-2008-03789-3-5 | New strengths (50/3 & 100/3) including extension of indications, New dosing range (200/6 only), Other simultaneous quality changes (100/6 and 200/6) | 26/02/2013 |
| AstraZeneca Pty Ltd | Rosuvastatin | Crestor / Visacor | PM-2009-01470-3-3 | Extension of indications | 25/05/2011 |
| AstraZeneca Pty Ltd | Aspirin / Esomeprazole | Axanum | PM-2010-03829-3-3 | New fixed combination | 09/08/2012 |
| AstraZeneca Pty Ltd | Naproxen / Esomeprazole | Vimovo | PM 2010-00846-3-3 | New fixed combination | 09/11/2011 |
| AstraZeneca Pty Ltd | Gefitinib | Iressa | PM-2009-02058-3-4 | Extension of indications | 29/06/2010 |
| AstraZeneca Pty Ltd | Ropivacaine | Naropin | PM-2009-01406-3-1 | Extension of indications | 23/04/2010 |
| AstraZeneca Pty Ltd | Ticagrelor | Brilinta | PM-2009-03523-3-3 | New chemical entity | 12/07/2011 |
| AstraZeneca Pty Ltd | Budesonide / Eformoterol fumarate dihydrate | Symbicort Turbuhaler 200/6, 400/12 / Symbicort Rapihaler 200/6 | PM-2008-1992-5 | Extension of indications | 20/10/2010 |
B - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Baxter Healthcare Pty Ltd | Fibrin sealant | Tisseel VH/SD | PM-2009-00290-3-4 | Extension of indications | 06/04/2010 |
| Baxter Healthcare Pty Ltd | Split virus / Vero cell derived / Inactivated influenza vaccine | Preflucel | PM-2010-03274-3-2 | New biological entity | 06/07/2012 |
| Baxter Healthcare Pty Ltd | Fibrin adhesive/sealant | Artiss | PM-2010-03599-3-4 | Extension of indications | 09/02/2012 |
| Baxter Healthcare Pty Ltd | Fibrin sealant / adhesive / haemostatic agent | Tisseel VH/SD | PM-2010-03271-3-4 | Extension of indications, Additional method of administration | 03/05/2012 |
| Baxter Healthcare Pty Ltd | Fibrin sealant | Artiss | PM-2009-01572-3-4 | New biological entity | 03/08/2010 |
| Baxter Healthcare Pty Ltd | Pandemic influenza vaccine | Pandemic Influenza Vaccine H5N1 Baxter | PM-2008-1961-2 | New biological entity | 09/12/2010 |
| Bayer Australia Limited | Aflibercept | Eylea | PM-2010-03802-3-5 | New chemical entity | 30/07/2012 |
| Bayer Australia Limited | Oestradiol valerate / Dienogest | Qlaira | PM-2009-02910-3-5 | Extension of indications | 28/03/2011 |
| Bayer Australia Ltd | Dienogest | Visanne | PM-2009-00539-3-5 | Extension of indication | 21/09/2010 |
| Bayer Australia Ltd | Vardenafil | Levitra | PM-2009-02689-3-3 | New dosage form and change in dosage instructions | 12/01/2011 |
| Bayer Australia Ltd | Rivaroxaban | Xarelto | PM-2010-03901-3-3 | Extension of indications | 13/09/2012 |
| Biogen Idec Australia Pty Ltd | Fampridine | Fampyra | PM-2010-00524-3-1 | New chemical entity | 15/06/2011 |
| Biotech Regulatory Solutions | Catumaxomab | Removab | PM-2010-03132-3-4 | New chemical entity | 04/10/2012 |
| Boehringer Ingelheim Pty Ltd | Alteplase | Actilyse | PM-2009-02729-3-1 | Extension of indications | 28/09/2010 |
| Boehringer Ingelheim Pty Ltd | Telmisartan | Micardis / Pritor | PM-2009-00165-3-3 | Extension of indications | 22/04/2010 |
| Boehringer Ingelheim Pty Ltd | Nevirapine | Viramune XR | PM-2010-03093-3-2 | New dosage form | 19/03/2012 |
| Boehringer Ingelheim Pty Ltd | Dabigatran etexilate mesilate | Pradaxa | PM-2010-00120-3-3 | Extension of indications, New strength, Changes to currently approved strengths | 24/05/2011 |
| Boehringer Ingelheim Pty Ltd | Telmisartan / Amlodipine | Twynsta | PM-2009-03138-3-3 | New fixed dose combination | 14/02/2011 |
| Boehringer Ingleheim (Australia) Pty Ltd | Linagliptin | Trajenta | PM-2010-02400-3-5 | New chemical entity | 12/12/2011 |
| Bristol-Myers Squibb / AstraZeneca | Saxagliptin | Onglyza | PM-2010-03800-3-5 | Major variation (new strength, new patient group, change in dosage) | 25/06/2012 |
| Bristol-Myers Squibb Australia Pty Ltd | Apixaban | Eliquis | PM-2010-01492-3-3 | New chemical entity | 20/09/2011 |
| Bristol-Myers Squibb Australia Pty Ltd | Saxagliptin hydrochloride | Onglyza | PM-2008-03469-3-5 | New chemical entity | 13/04/2011 |
| Bristol-Myers Squibb Australia Pty Ltd | Ipilimumab | Yervoy / Winglore | PM-2010-02212-3-4 | New biological entity | 10/08/2011 |
| Bristol-Myers Squibb Australia Pty Ltd | Abatacept (rch) | Orencia | PM-2008-03683-3-3 | Extension of indications | 04/03/2010 |
| Bristol-Myers Squibb Australia Pty Ltd | Belatacept | Nulojix | PM-2010-03075-3-2 | New chemical entity | 30/07/2012 |
| Bristol-Myers Squibb Australia Pty Ltd | Abatacept (rch) | Orencia | PM-2010-03115-3-3 | Major variation (new dosage form, new route of administration) | 26/04/2012 |
| Bristol-Myers Squibb Australia Pty Ltd | Abatacept (rch) | Orencia | PM-2010-00413-3-3 | Extension of indications | 15/06/2011 |
| Bristol-Myers Squibb Australia Pty Ltd | Dapagliflozin propanediol monohydrate | Appebb / AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin / Edistride / Empliciti / Forxiga | PM-2010-03812-35 | New chemical entity | 14/01/2013 |
| Bristol-Myers Squibb Australia Pty Ltd | Dasatinib | Sprycel | PM-2010-01583-3-4 | Major variation (extension of indications) | 11/07/2011 |
| Bristol-Myers Squibb Australia Pty Ltd / Sanofi-Aventis Australia Pty Ltd | Clopidogrel / Aspirin | DuoCover / CoPlavix | PM-2010-00534-3-4 / 2010-00535-3-3 | Extension of indications | 28/07/2011 |
| Bristol-Myers Squibb Australia Pty Ltd / Sanofi-Aventis Australia Pty Ltd | Aspirin / Clopidogrel | DuoCover / CoPlavix | PM-2010-00534-3-4 / 2010-00535-3-3 | Extension of indications | 28/07/2011 |
| Bristol-Myers Squibb Pharmaceuticals Pty Ltd | Aripiprazole | Abilify | PM-2010-00571-3-1 | Extension of indications | 03/03/2011 |
C - AusPARs by sponsor
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| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Commercial Eyes Pty Ltd | Melatonin | Circadin | PM-2008-2125-1 | New chemical entity | 28/11/2009 |
| CSL Bioplasma Ltd | Immunoglobulin - normal (human) | Intragam 10 NF | PM-2009-01544-3-2 | Extension of indications, New dosage | 18/10/2011 |
| CSL Limited | Human fibrinogen | RiaSTAP | PM-2009-01838-3-4 | New chemical entity | 13/10/2010 |
| CSL Limited, Bioplasma Division | Human C1 esterase inhibitor | Berinert | PM-2008-03232-3-2 | New chemical entity | 14/01/2010 |
| CSL Ltd | Tapentadol | Palexia SR | PM-2009-02489-3-1 | New chemical entity | 28/02/2011 |
| CSL Ltd | Albumin (human) | Albumex 20 / Albumex 5 / Albumex 4 | PM-2010-02082-3-5 | Extension of indications | 27/07/2011 |
| CSL Ltd | Immunoglobulin - normal (human) | Evogam | PM-2010-01887-3-2 | Major variations including New strength, New route of administration, Change in manufacture and tradename | 07/05/2012 |
| CSL Ltd | Tapentadol | Palexia IR | PM-2009-02488-3-1 | New chemical entity | 17/11/2010 |
| CSL Ltd Bioplasma Division | Human Prothrombin Complex | Beriplex P/N | PM-2008-2935-4 | New chemical entity | 15/01/2010 |
E - AusPARs by sponsor
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| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Eli Lilly Australia Pty Ltd | Teriparatide | Forteo | PM-2009-02138-3-5 | Major variation (extension of treatment duration) | 07/09/2010 |
| Eli Lilly Australia Pty Ltd | Exenatide | Byetta/Bydureon | PM-2010-02389-3-5 | Extension of indication, New dosage form | 05/02/2013 |
| Eli Lilly Australia Pty Ltd | Duloxetine | Cymbalta | PM-2010-03270-3-1 | Extension of Indications | 06/09/2012 |
| Eli Lilly Australia Pty Ltd | Tadalafil | Adcirca | PM-2010-01829-3-3 | Extension of indications and additional trade name | 20/09/2011 |
| Eli Lilly Australia Pty Ltd | Somatropin | Humatrope | PM-2010-00615-3-5 | Extension of Indication | 15/01/2013 |
F - AusPARs by sponsor
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| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Ferring Pharmaceuticals Pty Limited | Gonadotrophin - human menopausal | Menopur | PM-2009-01335-3-5 | New chemical entity | 12/10/2011 |
| Ferring Pharmaceuticals Pty Ltd | Somatropin | Zomacton | PM-2008-2954-5 | Major variation (New strength/New mode of administration) | 01/12/2010 |
| Ferring Pharmaceuticals Pty Ltd | Degarelix | Firmagon | PM-2008-2254-4 | New chemical entity | 16/02/2010 |
| Ferring Pharmaceuticals Pty Ltd | Terlipressin acetate | Glypressin | PM-2010-03182-3-3 | New Chemical Entity | 26/11/2012 |
| Fresenius Kabi Australia Pty Ltd | Soya oil / Medium chain triglycerides / Olive oil / Fish oil | SMOFlipid | PM-2008-03674-3-1 | New combination | 10/06/2010 |
| Fresenius Kabi Australia Pty Ltd | SMOFlipid 20% / Aminoven 10% (with or without electrolytes) / glucose 42% | SmofKabiven / SmofKabiven Electrolyte Free Emulsion | PM-2010-02110-3-1 | New fixed combination | 15/03/2012 |
| Shire Australia Pty Ltd | Icatibant | Firazyr | SM-2009-00755-3-2 | New chemical entity | 07/06/2010 |
G - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| GE Healthcare Australia Pty Ltd | Iodixanol | Visipaque | PM-2009-00811-3-2 | Extension of indications | 14/05/2010 |
| Genzyme Australasia Pty Ltd | Plerixafor | Mozobil | SM-2008-03602-4 | New chemical entity | 23/07/2010 |
| Gilead Sciences Pty Ltd | Adefovir dipivoxil | Hepsera | PM-2009-00296-3-2 | Extension of indications | 29/04/2010 |
| Gilead Sciences Pty Ltd | Tenofovir disoproxil fumarate / emtricitabine / rilpivirine | Eviplera | PM-2010-02853-3-2 | New chemical entity | 27/03/2012 |
| Gilead Sciences Pty Ltd | Aztreonam | Cayston | PM-2007-3666-2 | New dosage form | 02/02/2010 |
| Glaxo Smith Kline Australia Pty Ltd | Eltrombopag olamine | Revolade | SM- 2009-00082-3-4 | New chemical entity | 26/10/2010 |
| GlaxoSmithKline Australia Pty Ltd | Dutasteride / Tamsulosin | Duodart | PM-2009-01559-3-3 | New fixed dose combination | 20/10/2010 |
| GlaxoSmithKline Australia Pty Ltd | Belimumab | Benlysta | PM-2010-01980-3-2 | New biological entity | 31/10/2012 |
| GlaxoSmithKline Australia Pty Ltd | Remifentanil (as hydrochloride) | Ultiva | PM-2011-00909-3-1 | Major variation: New mode of administration | 29/01/2013 |
| GlaxoSmithKline Australia Pty Ltd | Human Papillomavirus Vaccine Types 16 and 18 (recombinant, AS04 adjuvanted) | Cervarix | PM-2009-02655-3-2 | Major variation (extension of indications) | 22/06/2011 |
| GlaxoSmithKline Australia Pty Ltd | Influenza virus haemagglutinin (Type A/California/7/2009 (H1N1)v-like strain adjuvanted to ASO3) | Pandemrix H1N1 pandemic influenza vaccine | PM-2010-02995-3-2 | Major variation: Change in patient group and dosing schedule. | 12/02/2013 |
| GlaxoSmithKline Australia Pty Ltd | Dutasteride | Avodart | PM-2009-02236-3-3 | Extension of indications | 22/09/2010 |
| GlaxoSmithKline Australia Pty Ltd | Lapatinib | Tykerb | PM-2011-00908-3-4 | Extension of indications | 12/11/2012 |
| GlaxoSmithKline Australia Pty Ltd | Pandemrix | Pandemic H1N1 influenza vaccine | PM-2009-03526-3-2 | Major variation | 20/10/2010 |
| GlaxoSmithKline Australia Pty Ltd | Lapatinib | Tykerb | PM-2009-01276-3-4 | Extension of indications | 17/06/2010 |
| GlaxoSmithKline Australia Pty Ltd | Hib and group C Meningococcal conjugate vaccine | Menitorix | PM-2009-00817-3-2 | New biological entity (new combination vaccine) | 02/08/2010 |
| GlaxoSmithKline Australia Pty Ltd | Ofatumumab | Arzerra | PM-2009-02159-3-4 | New biological entity | 15/12/2010 |
| GlaxoSmithKline Pty Ltd | Pneumococcal polysaccharide conjugate vaccine, 10-valent adsorbed | Synflorix | PM-2010-02793-3-2 | Major Variation (Extension of Indication) | 22/10/2012 |
| Grunenthal Pty Ltd | Tramadol hydrochloride / Paracetamol | Zaldiar | PM-2010-3272-3-1 | New fixed combination | 13/09/2012 |
| GSK Australia Pty Ltd | Pandemic influenza vaccine | Arepanrix H5N1 | PM-2009-03131-3-2 | New biological entity | 01/02/2011 |
H - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Helex-A Pty Ltd | Allergen pollen extract of 5 grasses | Oralair Sublingual Tablets | PM-2009-03500-3-2 | New route of administration, New dosage form | 15/06/2011 |
| Hospira Pty Ltd | Filgrastim | Nivestim | PM-2009-00676-3-4 | New chemical entity (biosimilar product) | 13/09/2010 |
I - AusPARs by sponsor
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| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| iNova Pharmaceuticals (Australia) Pty Ltd | Rupatadine | Rupafin | PM-2009-03232-3-5 | New chemical entity | 18/05/2011 |
| Invida Australia Pty Ltd | Indomethacin | Indocid PDA | PM-2009-03539-3-3 | Major variation (change in dosage and patient population) | 18/03/2011 |
| Invida Australia Pty Ltd | Granisetron | Sancuso | PM-2009-02620-3-4 | New route of administration, New dosage form | 21/06/2011 |
J - AusPARs by sponsor
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| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Janssen-Cilag Australia Pty Ltd | Paliperidone palmitate | Invega Sustenna | PM-2009-00926-3-1 | New salt of a previously approved active ingredient | 20/07/2010 |
| Janssen-Cilag Pty Ltd | Trabectedin | Yondelis | PM-2009-01976-3-4 | New chemical entity | 09/11/2010 |
| Janssen-Cilag Pty Ltd | Abiraterone acetate | Zytiga | PM-2010-03604-3-4 | New chemical entity | 04/10/2012 |
| Janssen-Cilag Pty Ltd | Prucalopride | Resotrans | PM-2010-03060-3-1 | New chemical entity | 23/11/2011 |
| Janssen-Cilag Pty Ltd | Paliperidone | Invega | PM-2009-00515-3-1 | Extension of indications | 14/12/2009 |
| Janssen-Cilag Pty Ltd | Bortezomib | Velcade | PM-2011-00854-3-4 | Major variation (new route of administration; subcutaneous (SC) injection). | 16/01/2013 |
| Janssen-Cilag Pty Ltd | Abiraterone acetate | Zytiga | PM-2010-03604-3-4 | New chemical entity | 13/09/2012 |
| Janssen-Cilag Pty Ltd | Tacrolimus | Prograf-XL | PM-2008-03783-3-2 | New dosage form | 06/05/2010 |
| Janssen-Cilag Pty Ltd | Telaprevir | Incivo | Janssen-Cilag Pty Ltd | New chemical entity | 26/10/2012 |
| Janssen-Cilag Pty Ltd | Risperidone | Risperdal Consta | PM-2008-03495-3-1 | Extension of indications | 18/06/2010 |
| Janssen-Cilag Pty Ltd | Infliximab | Remicade | PM-2011-00196-3-1 | Extension of indications | 17/12/2012 |
| Janssen-Cilag Pty Ltd | Bortezomib | Velcade | PM-2010-03250-3-4 | Extension of indications | 30/11/2011 |
| Janssen-Cilag Pty Ltd | Dapoxetine | Priligy | PM-2007-3614-3 | New chemical entity | 23/11/2010 |
| Janssen-Cilag Pty Ltd | Rilpivirine | Edurant | PM-2010-03030-3-2 | New chemical entity | 27/03/2012 |
| Johnson & Johnson Medical Pty Ltd | Fibrin haemostatic agent/sealant | Evicel | PM-2009-03561-3-4 | New Chemical Entity | 11/12/2012 |
K - AusPARs by sponsor
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| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Kendle Australia Pty Ltd | Clevidipine | Cleviprex | PM-2008-3132-3 | New chemical entity | 12/04/2010 |
| Kendle R&D Pty Limited | Iloperidone | Fanapt | PM-2010-02772-3 | New chemical entity | 18/06/2012 |
L - AusPARs by sponsor
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| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Link Medical Products P/L | Immunoglobulin - normal (human) | Intratect | PM-2009-02495-3-2 | New chemical entity | 03/02/2011 |
| Link Medical Products Pty Ltd | Cyclizine lactate | Valoid | PM-2010-03573-3-1 | New chemical entity | 15/01/2013 |
| Lundbeck Australia Pty Ltd | Rasagiline | Azilect | PM-2010-00798-3-1 | New chemical entity | 08/02/2012 |
M - AusPARs by sponsor
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| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Merck Serono Australia Pty Ltd | Cetuximab | Erbitux | PM-2009-02587-4 | Extension of indications | 19/10/2011 |
| Merck Serono Australia Pty Ltd | Cladribine | Movectro | PM-2009-02909-3-1 | Extension of indications, New dose form, New route of administration | 06/07/2011 |
| Merck Serono Australia Pty Ltd | Sapropterin dihydrochloride | Kuvan | PM-2009-02891-3-3 | New chemical entity | 21/10/2010 |
| Merck Serono Australia Pty Ltd | Cetuximab | Erbitux | PM-2008-03405-3-4 | Extension of indications | 15/01/2010 |
| Merck Sharp & Dohme (Australia) Pty Limited | Nomegestrol acetate / Oestradiol | Zoely | PM-2010-00254-3-5 | New chemical entity | 04/10/2011 |
| Merck Sharp & Dohme (Australia) Pty Ltd | Boceprevir | Victrelis | PM-2010-03273-3-2 | New chemical entity | 23/04/2012 |
| Merck Sharp & Dohme (Australia) Pty Ltd | Human papillomavirus quadrivalent vaccine | Gardasil | PM-2009-00914-2 | Extension of indications | 08/10/2010 |
| Merck Sharp & Dohme (Australia) Pty Ltd | Olmesartan medoxomil | Olmetec | PM-2011-01941-3-3 | Major Variation (New Dosage Form, Increase in Patient Group) | 26/02/2013 |
| Merck Sharp & Dohme (Australia) Pty Ltd | Tafluprost | Saflutan | PM-2009-3896-5 | New chemical entity | 03/05/2012 |
| Merck Sharp & Dohme (Australia) Pty Ltd | Aprepitant | Emend | PM-2011-00237-3-4 | Major variation: new dosage regimen and new dosage | 12/11/2012 |
| Merck Sharp and Dohme (Australia) Pty Limited | Ezetimibe | Ezetrol | PM-2011-01220-3-3 | Extention of Indication | 28/02/2013 |
| Merck Sharp and Dohme (Australia) Pty Limited | Ezetimibe/Simvastatin | Vytorin | PM-2011-01219-3-1 | Extension of indications | 28/02/2013 |
| Merck Sharpe & Dohme (Australia) Pty Limited | Human papillomavirus (Types 6, 11, 16 & 18) quadrivalent recombinant vaccine | Gardasil | PM-2010-03191-3-2 | Extension of indications | 07/05/2012 |
| Merck Sharpe & Dohme (Australia) Pty Ltd | Vernakalant | Brinavess | PM-2010-01025-3-3 | New chemical entity | 12/11/2012 |
| Merck Sharpe and Dohme (MSD) Australia Pty Ltd | Metformin/Sitagliptin | Janumet | PM-2011-01226-3-5 | Extension of Indications | 14/01/2013 |
| Merck Sharpe and Dohme (MSD) Australia Pty Ltd | Sitagliptin/Metformin | Janumet | PM-2011-01226-3-5 | Extension of Indications | 14/01/2013 |
| MS Health | Misoprostol | GyMiso | PM-2011-01625-3-5 | Extension of indications | 02/10/2012 |
| MS Health | Mifepristone | Mifepristone Linepharma | PM-2010-02694-3-5 | New chemical entity | 02/10/2012 |
| MSD (Australia) Pty Limited | Sitagliptin (as phosphate monohydrate) | Januvia | PM 2011-01224-3-5 | Extension of indications | 20/12/2012 |
| Mundipharma Pty Ltd | Oxycodone hydrochloride / Naloxone hydrochloride | Targin | PM-2008-2938-1 | New fixed combination | 04/05/2010 |
N - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Merck Serono Australia Pty Ltd | Follitropin alfa (rch) / Lutropin alfa (rch) | Pergoveris | PM-2008-1439-5 | New fixed combination | 11/01/2010 |
| Norgine Pty Ltd | Rifaximin | Xifaxan | PM-2011-00501-3-1 | New Chemical Entity | 19/11/2012 |
| Novartis Australia Pty Ltd | Zoledronic acid | Aclasta / Osteovan | PM-2010-01920-3-5 | Major variation | 31/08/2011 |
| Novartis Pharmaceuticals Australia Pty Limited | Fingolimod | Gilenya / Fynefta/ Filosir | PM-2010-00401-3-1 | New chemical entity | 29/03/2011 |
| Novartis Pharmaceuticals Australia Pty Limited | Amlodipine (as besylate) / Valsartan / Hydrochlorothiazide | Exforge HCT / Ejocia HCT | PM-2008-03499-3-3 | New fixed combination | 26/08/2010 |
| Novartis Pharmaceuticals Australia Pty Ltd | Aliskiren / Amlodipine / Hydrochlorothiazide | Rasilamlo HCT | PM-2010-02677-3-3 | New combination (of previously approved active ingredients) | 15/06/2012 |
| Novartis Pharmaceuticals Australia Pty Ltd | Everolimus | Afinitor | PM-2011-01215-3-4 | Extension of indications | 26/02/2013 |
| Novartis Pharmaceuticals Australia Pty Ltd | Ranibizumab | Lucentis | PM-2010-02527-3-5 | Extension of indications | 09/11/2011 |
| Novartis Pharmaceuticals Australia Pty Ltd | Tobramycin inhalation powder | TOBI Podhaler | PM-2011-00135-3-2 | New dosage form | 26/10/2012 |
| Novartis Pharmaceuticals Australia Pty Ltd | Vildagliptin | Galvus / Xiliarx | PM-2009-00158-3-5 | New chemical entity | 23/02/2010 |
| Novartis Pharmaceuticals Australia Pty Ltd | Vildagliptin / Metformin hydrochloride | Galvumet / Sobrea | PM-2009-00972-3-5 | New fixed combination | 07/12/2010 |
| Novartis Pharmaceuticals Australia Pty Ltd | Indacaterol | Onbrez Breezhaler / Arbeela Breezhaler | PM-2009-00350-3-5 | New chemical entity | 27/10/2010 |
| Novartis Pharmaceuticals Australia Pty Ltd | Aliskiren (as hemifumarate) / Hydrochlorothiazide | Rasilez HCT / Enviage HCT | PM-2008-2072-3 | New fixed combination | 12/03/2010 |
| Novartis Pharmaceuticals Australia Pty Ltd | Nilotinib | Tasigna | PM-2010-01053-3-4 | Extension of indications, New strength | 04/10/2011 |
| Novartis Pharmaceuticals Australia Pty Ltd | Ocreotide | Sandostatin LAR | PM-2010-03092-3-4 | Extension of indications | 14/02/2012 |
| Novartis Pharmaceuticals Australia Pty Ltd | Aliskiren / Amlodipine | Rasilamlo | PM-2010-00719-3-3 | New fixed combination | 05/08/2011 |
| Novartis Pharmaceuticals Australia Pty Ltd | Amlodipine / Valsartan | Exforge/Ejocia 5/320 / Exforge/Ejocia 10/320 | PM-2009-01168-3-3 | Major variation (new strength) | 26/07/2010 |
| Novartis Pharmaceuticals Australia Pty Ltd | Ranibizumab | Lucentis | PM-2010-03258-3-5 | Extension of indications, Changes to Product Information | 01/12/2011 |
| Novartis Vaccines and Diagnostics | Influenza Virus Haemagglutinin H5N1 | Aflunov / Prepandemic H5N1 adjuvanted Influenza Vaccine | PM-2009-03929-3-2 | New biosimilar medicine similar to other pandemic and seasonal influenza vaccines | 06/07/2011 |
| Novartis Vaccines and Diagnostics Pty Ltd | Trivalent seasonal influenza vaccine, inactivated / MF59C.1 adjuvanted | Fluad Paediatric | PM-2010-03905-3-2 | New biological entity | 04/10/2012 |
| Novartis Vaccines and Diagnostics Pty Ltd | Meningococcal conjugated vaccine | Menveo | SM-2009-00001-3-2 | New chemical entity | 20/05/2010 |
| Novo Nordisk Pharmaceuticals Pty Limited | Liraglutide (rys) | Victoza | PM-2008-2113-5 | New biological entity | 22/11/2010 |
| Novo Nordisk Pharmaceuticals Pty Ltd | Oestradiol / Norethisterone acetate | Kliovance Low | PM-2010-00087-5-3 | New strength | 18/01/2012 |
| Nycomed Pty Ltd | Ciclesonide | Omnaris | PM-2009-03337-3-5 | New dose form, New route of administration, Extension of indications | 18/01/2012 |
| Nycomed Pty Ltd | Human Fibrinogen / Human Thrombin | TachoSil | PM-2010-02840-3-4 | New fixed combination | 31/08/2012 |
| Nycomed Pty Ltd | Roflumilast | Daxas / Xevex / Dalveza | PM-2009-02915-3-5 | New chemical entity | 20/12/2011 |
O - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Orphan Australia Pty Ltd | Nitisinone | Orfadin | PM-2009-02266-3-3 | New chemical entity | 15/10/2010 |
| Orphan Australia Pty Ltd | Deferiprone | Ferriprox | PM-2010-00539-3-4 | Extension of indications, Increase in dosage, Other changes to the Product Information | 04/10/2011 |
| Orphan Australia Pty Ltd | Ursodeoxycholic acid | Urso / Ursofalk | PM-2008-03582-3-1 | Extension of indications, Change of dosage | 28/07/2010 |
| Orphan Australia Pty Ltd | Tolvaptan | Samsca | PM-2010-02939-3-5 | New chemical entity | 04/10/2012 |
| Orphan Australia Pty Ltd | Budesonide | Budenofalk | PM-2010-03268-3-1 | Major variation, new indications, new dose form | 22/10/2012 |
| Orphan Australia Pty Ltd | Anagrelide hydrochloride | Thromboreductin | PM-2009-03102-3-4 | Orphan drug | 07/05/2012 |
P - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Pfizer Australia | Somatropin | Genotropin | PM-2008-2730-5 | Product information change, requiring the evaluation of clinical, non-clinical or bioequivalence data | 09/03/2010 |
| Pfizer Australia Pty Ltd | Sildenafil | Revatio | PM-2010-00912-3-3 | Extension of indications, Major variation | 12/10/2011 |
| Pfizer Australia Pty Ltd | Etanercept | Enbrel | PM-2010-03845-3-4 | Extension of indications | 19/03/2012 |
| Pfizer Australia Pty Ltd | Ziprasidone mesilate | Zeldox IM | PM-2008-1737-1 | New dosage form | 18/12/2009 |
| Pfizer Australia Pty Ltd | Pneumococcal Polysaccharide Conjugate Vaccine 13 valent | Prevenar 13 | PM-2010-03262-3-2 | Extension of indications, Changes to the Product Information | 13/12/2011 |
| Pfizer Australia Pty Ltd | Celecoxib | Celebrex | PM-2009-01564-3-1 | Extension of indications | 23/06/2010 |
| Pfizer Australia Pty Ltd | Tranexamic acid | Cyklokapron | PM-2009-00587 | Extension of indications, New dosage form | 10/09/2010 |
| Pfizer Australia Pty Ltd | Sildenafil | Revatio | PM-2010-00820-3-3 | Extension of indications | 19/10/2011 |
| Pfizer Australia Pty Ltd | Dalteparin | Fragmin | PM-2009-00586-3-3 | Extension of indications | 27/05/2010 |
| Pfizer Australia Pty Ltd | Sunitinib | Sutent | PM-2010-01205-4 | Extension of indications, New dosage | 29/06/2011 |
| Pfizer Australia Pty Ltd | Medroxyprogesterone acetate | Sayana | PM-2009-03498-3-5 | Major variation (new route of administration) | 27/07/2011 |
| Pharmaxis Ltd | Mannitol | Bronchitol | PM-2009-03748-3-5 | Extension of indications | 29/03/2011 |
| Phebra Pty Ltd | Ibuprofen | Caldolor | PM-2010-02393-3-1 | Major Variation (New dose form/New route of administration) | 02/01/2013 |
| Phebra Pty Ltd | Colistimethate sodium | Tadim | PM-2009-02764-3-2 | New dose form, New route of administration | 13/01/2011 |
| Phebra Pty Ltd | Caffeine citrate | Cafnea | PM-2008-2175-5 | New chemical entity | 17/03/2010 |
| Pierre Fabre Medicament Australia Pty Ltd | Milnacipran | Joncia | PM-2011-02708-3-1 | New chemical entity | 24/01/2012 |
| Pierre Fabre Medicament Australia Pty Ltd | Vinorelbine | Navelbine | PM-2010-03252-3-4 | Extension of indications | 30/05/2012 |
| Pierre Fabre Medicament Australia Pty Ltd | Vinflunine ditartrate | Javlor | PM-2009-03102-3-4 | New chemical entity | 07/02/2011 |
R - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| RAD Data Australia Pty Ltd | Melatonin | Circadin | PM-2010-01756-3-1 | Extension of indications | 18/01/2011 |
| Reckitt Benckiser (Australia) Pty Ltd | Buprenorphine / Naloxone | Suboxone Sublingual Film | PM-2009-01902-3-1 | New dose form | 07/12/2010 |
| Roche Australia Pty Ltd | Peginterferon alfa-2a / Ribavirin | Pegasys RBV / Pegasys / Copegus | PM-2010-00382/00415/00416-3-2 | Major variation | 15/06/2011 |
| Roche Products Pty Limited | Erlotinib | Tarceva | PM-2011-01993-3-4 | Extension of Indications | 07/01/2013 |
| Roche Products Pty Limited | Vemurafenib | Zelboraf | PM-2011-00795-3-4 | New Chemical Entity | 17/12/2012 |
| Roche Products Pty Ltd | Oseltamivir phosphate | Tamiflu | PM-2010-00616-3-2 | Major variation (extension of indications/new population) | 27/07/2011 |
| Roche Products Pty Ltd | Trastuzumab | Herceptin | 2011-01528-3-4 | Extension of indications | 17/12/2012 |
| Roche Products Pty Ltd | Erlotinib | Tarceva | PM-2009-00835-3-4 | Extension of indications | 09/11/2010 |
| Roche Products Pty Ltd | Trastuzumab | Herceptin | PM-2009-03121 | Major variation (extension of indications) | 17/09/2010 |
| Roche Products Pty Ltd | Rituximab | MabThera | PM-2010-01845-3-4 | New dosage regimen | 09/12/2011 |
| Roche Products Pty Ltd | Bevacizumab | Avastin | PM-2010-3786-3-4 | Extension of indications | 06/08/2012 |
| Roche Products Pty Ltd | Tocilizumab | Actemra | PM-2009-03295-3-3 | Extension of indications | 13/01/2011 |
| Roche Products Pty Ltd | Rituximab | MabThera | PM-2009-00656-3-4 | Extension of indications | 19/02/2010 |
| Roche Products Pty Ltd | Tocilizumab | Actemra | PM-2010-03070-3-3 | Extension of indications | 06/12/2011 |
| Roche Products Pty Ltd | Rituximab | MabThera | PM-2009-01744-3-3 | Extension of indications, Broaden patient population | 06/05/2010 |
| Roche Products Pty Ltd | Bevacizumab | Avastin | PM-2009-00515-3-1 | Extension of indication | 14/12/2009 |
| Roche Products Pty Ltd / Sanofi-Aventis Australia Pty Ltd | Capecitabine / Oxaliplatin | Xeloda / Eloxatin / Oxaliplatin Dakota / Winthrop Oxaliplatin | PM-2010-00909-4/2010-02795-4 | Major variation (Extension of indications, New dosage) | 23/03/2011 |
S - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Sanofi Aventis Australia Pty Ltd | Dronedarone hydrochloride | Multaq / Dronedarone Winthrop / Dronedarone Sanofi | PM-2008-3045-3 | New chemical entity | 05/10/2010 |
| Sanofi Pasteur Pty Ltd | Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine - Groups A, C, Y and W-135 | Menactra | PM-2010-00277-3-5 | New chemical entity | 31/08/2011 |
| Sanofi Pasteur Pty Ltd | Japanese Encephalitis Chimeric Virus | Imojev | PM-2009-01554-3-2 | New chemical entity | 16/08/2010 |
| Sanofi-Aventis Australia Pty Ltd | Cabazitaxel | Jevtana | PM-2010-02565-3-4 | New chemical entity | 09/02/2012 |
| Sanofi-Aventis Australia Pty Ltd / Bristol-Myers Squibb Australia Pty Ltd | Clopidogrel / Aspirin | CoPlavix / DuoCover | PM-2010-00534-3-4 / 2010-00535-3-3 | Extension of indications | 28/07/2011 |
| Sanofi-Aventis Australia Pty Ltd / Bristol-Myers Squibb Australia Pty Ltd | Aspirin / Clopidogrel | CoPlavix / DuoCover | PM-2010-00534-3-4 / 2010-00535-3-3 | Extension of indications | 28/07/2011 |
| Sanofi-Aventis Australia Pty Ltd/Roche Products Pty Ltd | Oxaliplatin / Capecitabine | Eloxatin / Oxaliplatin Dakota / Winthrop Oxaliplatin / Xeloda | PM-2010-00909-4/2010-02795-4 | Major variation (Extension of indications, New dosage) | 23/03/2011 |
| Schering-Plough Pty Limited | Asenapine | Saphris | PM-2009-03233-3-1 | New chemical entity | 07/03/2011 |
| Schering-Plough Pty Ltd | Corifollitropin alfa | Elonva | PM-2009-00870-3-5 | New chemical entity | 21/07/2010 |
| Schering-Plough Pty Ltd | Olmesartan medoxomil / Amlodipine besylate | Sevikar | PM-2008-03320-3-3 | New fixed dose combination | 21/09/2010 |
| Schering-Plough Pty Ltd | Golimumab | Simponi | PM-2008-1811-3 | New biological entity | 14/12/2009 |
| Servier Laboratories (Aust) Pty Ltd | Perindopril arginine / Amlodipine (as besylate) | Coveram | PM-2008-2262-3 | New combination | 13/11/2009 |
| Servier Laboratories (Australia) Pty Ltd | Ivabradine | Coralan | PM-2008-2832-3 | Extension of indications | 03/09/2010 |
| Servier Laboratories (Australia) Pty Ltd | Ivabradine | Coralan | PM-2010-03269-3-3 | Major Variation (Extension of indications) | 31/10/2012 |
| Servier Laboratories (Australia) Pty Ltd | Strontium ranelate | Protos | PM-2011-00498-3-5 | Extension of indications | 07/01/2013 |
| Servier Laboratories (Australia) Pty Ltd | Agomelatine | Valdoxan | PM-2009-00483-3-1 | New chemical entity | 21/10/2010 |
| Shire Australia Pty Limited | Agalsidase alfa ghu | Replagal | PM-2009-01140-3-3 | New manufacturing process | 18/06/2010 |
| Shire Australia Pty Limited | Lanthanum carbonate | Fosrenol | PM-2010-01654-3-3 | Extension of indications | 14/02/2012 |
| Shire Australia Pty Ltd | Velaglucerase alfa (ghu) | VPRIV | PM-2010-03810-3-3 | New chemical entity (biological) | 07/05/2012 |
| Shire Australia Pty Ltd | Icatibant | Firazyr | SM-2009-00755-3-2 | New chemical entity | 07/06/2010 |
T - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Talecris Biotherapeutics Pty Ltd | Immunoglobulin - normal (human) | Gamunex | PM-2010-01870-3-201870-3-2 | Extension of indications, New route of administration | 13/12/2011 |
U - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| UCB Australia Pty Ltd | Rotigotine | Neupro | PM-2009-01999-3-1 | Extension of indications, Registration of two new strengths | 08/10/2010 |
| UCB Australia Pty Ltd | Certolizumab pegol | Cimzia | PM-2008-2508-3 | New biological entity | 22/12/2009 |
V - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Vifor Pharma Pty Ltd | Ferric carboxymaltose | Ferinject | PM-2009-01623-3-4 | New chemical entity | 24/05/2011 |
W - AusPARs by sponsor
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Sponsor | Active ingredient | Proprietary product name | Submission no. | Submission type | Date of AusPAR |
|---|---|---|---|---|---|
| Wyeth Australia Pty Ltd | Etanercept | Enbrel | PM-2008-03723-3-4 | Extension of indications | 16/02/2010 |
| Wyeth Australia Pty Ltd | Pneumococcal Polysaccharide Conjugate Vaccine | Prevenar 13 | PM-2009-00110-3-2 | New biological entity | 13/05/2010 |
Content last updated: Monday, 29 April 2013
Content last reviewed: Monday, 29 April 2013
Web page last updated: Thursday, 31 January 2013
URL: http://www.tga.gov.au/industry/pm-auspar-sponsor.htm