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