Browse AusPARs by active ingredient
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 active ingredient is the component in the medicine that makes it work.
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 active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Abatacept (rch) | Orencia | Bristol-Myers Squibb Australia Pty Ltd | PM-2010-03115-3-3 | Major variation (new dosage form, new route of administration) | 26/04/2012 |
| Abatacept (rch) | Orencia | Bristol-Myers Squibb Australia Pty Ltd | PM-2010-00413-3-3 | Extension of indications | 15/06/2011 |
| Abatacept (rch) | Orencia | Bristol-Myers Squibb Australia Pty Ltd | PM-2008-03683-3-3 | Extension of indications | 04/03/2010 |
| Abiraterone acetate | Zytiga | Janssen-Cilag Pty Ltd | PM-2010-03604-3-4 | New chemical entity | 13/09/2012 |
| Abiraterone acetate | Zytiga | Janssen-Cilag Pty Ltd | PM-2010-03604-3-4 | New chemical entity | 04/10/2012 |
| Adefovir dipivoxil | Hepsera | Gilead Sciences Pty Ltd | PM-2009-00296-3-2 | Extension of indications | 29/04/2010 |
| Aflibercept | Eylea | Bayer Australia Limited | PM-2010-03802-3-5 | New chemical entity | 30/07/2012 |
| Agalsidase alfa ghu | Replagal | Shire Australia Pty Limited | PM-2009-01140-3-3 | New manufacturing process | 18/06/2010 |
| Agomelatine | Valdoxan | Servier Laboratories (Australia) Pty Ltd | PM-2009-00483-3-1 | New chemical entity | 21/10/2010 |
| Albumin (human) | Albumex 20 / Albumex 5 / Albumex 4 | CSL Ltd | PM-2010-02082-3-5 | Extension of indications | 27/07/2011 |
| Alendronic acid | Alendraccord / Alendrocor / Pharmacor Alendronate | Accord Healthcare Pty Ltd | PM-2009-01135-3-5 | New generic | 16/02/2011 |
| Aliskiren (as hemifumarate) / Hydrochlorothiazide | Rasilez HCT / Enviage HCT | Novartis Pharmaceuticals Australia Pty Ltd | PM-2008-2072-3 | New fixed combination | 12/03/2010 |
| Aliskiren / Amlodipine | Rasilamlo | Novartis Pharmaceuticals Australia Pty Ltd | PM-2010-00719-3-3 | New fixed combination | 05/08/2011 |
| Aliskiren / Amlodipine / Hydrochlorothiazide | Rasilamlo HCT | Novartis Pharmaceuticals Australia Pty Ltd | PM-2010-02677-3-3 | New combination (of previously approved active ingredients) | 15/06/2012 |
| Allergen pollen extract of 5 grasses | Oralair Sublingual Tablets | Helex-A Pty Ltd | PM-2009-03500-3-2 | New route of administration, New dosage form | 15/06/2011 |
| Alteplase | Actilyse | Boehringer Ingelheim Pty Ltd | PM-2009-02729-3-1 | Extension of indications | 28/09/2010 |
| Aminoven 10% (with or without electrolytes) / SMOFlipid 20% / glucose 42% | SmofKabiven / SmofKabiven Electrolyte Free Emulsion | Fresenius Kabi Australia Pty Ltd | PM-2010-02110-3-1 | New fixed combination | 15/03/2012 |
| Amlodipine (as besylate) / Perindopril arginine | Coveram | Servier Laboratories (Aust) Pty Ltd | PM-2008-2262-3 | New combination | 13/11/2009 |
| Amlodipine (as besylate) / Valsartan / Hydrochlorothiazide | Exforge HCT / Ejocia HCT | Novartis Pharmaceuticals Australia Pty Limited | PM-2008-03499-3-3 | New fixed combination | 26/08/2010 |
| Amlodipine / Aliskiren | Rasilamlo | Novartis Pharmaceuticals Australia Pty Ltd | PM-2010-00719-3-3 | New fixed combination | 05/08/2011 |
| Amlodipine / Aliskiren / Hydrochlorothiazide | Rasilamlo HCT | Novartis Pharmaceuticals Australia Pty Ltd | PM-2010-02677-3-3 | New combination (of previously approved active ingredients) | 15/06/2012 |
| Amlodipine / Telmisartan | Twynsta | Boehringer Ingelheim Pty Ltd | PM-2009-03138-3-3 | New fixed dose combination | 14/02/2011 |
| Amlodipine / Valsartan | Exforge/Ejocia 5/320 / Exforge/Ejocia 10/320 | Novartis Pharmaceuticals Australia Pty Ltd | PM-2009-01168-3-3 | Major variation (new strength) | 26/07/2010 |
| Amlodipine besylate / Olmesartan medoxomil | Sevikar | Schering-Plough Pty Ltd | PM-2008-03320-3-3 | New fixed dose combination | 21/09/2010 |
| Anagrelide hydrochloride | Thromboreductin | Orphan Australia Pty Ltd | PM-2009-03102-3-4 | Orphan drug | 07/05/2012 |
| Apixaban | Eliquis | Bristol-Myers Squibb Australia Pty Ltd | PM-2010-01492-3-3 | New chemical entity | 20/09/2011 |
| Aprepitant | Emend | Merck Sharp & Dohme (Australia) Pty Ltd | PM-2011-00237-3-4 | Major variation: new dosage regimen and new dosage | 12/11/2012 |
| Aripiprazole | Abilify | Bristol-Myers Squibb Pharmaceuticals Pty Ltd | PM-2010-00571-3-1 | Extension of indications | 03/03/2011 |
| Asenapine | Saphris | Schering-Plough Pty Limited | PM-2009-03233-3-1 | New chemical entity | 07/03/2011 |
| Aspirin / Clopidogrel | CoPlavix / DuoCover | 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 |
| Aspirin / Esomeprazole | Axanum | AstraZeneca Pty Ltd | PM-2010-03829-3-3 | New fixed combination | 09/08/2012 |
| Aztreonam | Cayston | Gilead Sciences Pty Ltd | PM-2007-3666-2 | New dosage form | 02/02/2010 |
B - AusPARs by active ingredient
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| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Belatacept | Nulojix | Bristol-Myers Squibb Australia Pty Ltd | PM-2010-03075-3-2 | New chemical entity | 30/07/2012 |
| Belimumab | Benlysta | GlaxoSmithKline Australia Pty Ltd | PM-2010-01980-3-2 | New biological entity | 31/10/2012 |
| Bevacizumab | Avastin | Roche Products Pty Ltd | PM-2010-3786-3-4 | Extension of indications | 06/08/2012 |
| Bevacizumab | Avastin | Roche Products Pty Ltd | PM-2009-00515-3-1 | Extension of indication | 14/12/2009 |
| Boceprevir | Victrelis | Merck Sharp & Dohme (Australia) Pty Ltd | PM-2010-03273-3-2 | New chemical entity | 23/04/2012 |
| Bortezomib | Velcade | Janssen-Cilag Pty Ltd | PM-2011-00854-3-4 | Major variation (new route of administration; subcutaneous (SC) injection). | 16/01/2013 |
| Bortezomib | Velcade | Janssen-Cilag Pty Ltd | PM-2010-03250-3-4 | Extension of indications | 30/11/2011 |
| Bosentan | Tracleer | Actelion Pharmaceuticals Australia | PM-2010-02897-3-4 | Major Variation, New Indication | 05/09/2012 |
| Botulinum toxin type A | Botox | Allergan Australia Pty Ltd | PM-2010-03508-3-3 | Extension of indications | 06/07/2012 |
| Botulinum toxin type A | Botox | Allergan Australia Pty Ltd | PM-2009-03219-3-1 | Extension of indications | 15/06/2011 |
| Brimonidine tartrate | Alphagan P / Enidin P | Allergan Australia Pty Ltd | PM-2008-03768-3-5 | New strength, Change in formulation, Two new trade names | 24/05/2010 |
| Brinzolamide / Timolol Maleate | Azarga | Alcon Laboratories (Australia) Pty Ltd | PM-2008-3124-5 | New fixed combination | 19/02/2010 |
| Budesonide | Budenofalk | Orphan Australia Pty Ltd | PM-2010-03268-3-1 | Major variation, new indications, new dose form | 22/10/2012 |
| Budesonide / Eformoterol | Symbicort Rapihaler | 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 |
| Budesonide / Eformoterol fumarate dihydrate | Symbicort Turbuhaler 200/6, 400/12 / Symbicort Rapihaler 200/6 | AstraZeneca Pty Ltd | PM-2008-1992-5 | Extension of indications | 20/10/2010 |
| Buprenorphine / Naloxone | Suboxone Sublingual Film | Reckitt Benckiser (Australia) Pty Ltd | PM-2009-01902-3-1 | New dose form | 07/12/2010 |
C - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Cabazitaxel | Jevtana | Sanofi-Aventis Australia Pty Ltd | PM-2010-02565-3-4 | New chemical entity | 09/02/2012 |
| Caffeine citrate | Cafnea | Phebra Pty Ltd | PM-2008-2175-5 | New chemical entity | 17/03/2010 |
| Capecitabine / Oxaliplatin | Xeloda / Eloxatin / Oxaliplatin Dakota / Winthrop 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 |
| Catumaxomab | Removab | Biotech Regulatory Solutions | PM-2010-03132-3-4 | New chemical entity | 04/10/2012 |
| Celecoxib | Celebrex | Pfizer Australia Pty Ltd | PM-2009-01564-3-1 | Extension of indications | 23/06/2010 |
| Certolizumab pegol | Cimzia | UCB Australia Pty Ltd | PM-2008-2508-3 | New biological entity | 22/12/2009 |
| Cetuximab | Erbitux | Merck Serono Australia Pty Ltd | PM-2009-02587-4 | Extension of indications | 19/10/2011 |
| Cetuximab | Erbitux | Merck Serono Australia Pty Ltd | PM-2008-03405-3-4 | Extension of indications | 15/01/2010 |
| Ciclesonide | Omnaris | Nycomed Pty Ltd | PM-2009-03337-3-5 | New dose form, New route of administration, Extension of indications | 18/01/2012 |
| Cladribine | Movectro | Merck Serono Australia Pty Ltd | PM-2009-02909-3-1 | Extension of indications, New dose form, New route of administration | 06/07/2011 |
| Clevidipine | Cleviprex | Kendle Australia Pty Ltd | PM-2008-3132-3 | New chemical entity | 12/04/2010 |
| Clopidogrel / Aspirin | CoPlavix / DuoCover | 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 |
| Colistimethate sodium | Tadim | Phebra Pty Ltd | PM-2009-02764-3-2 | New dose form, New route of administration | 13/01/2011 |
| Corifollitropin alfa | Elonva | Schering-Plough Pty Ltd | PM-2009-00870-3-5 | New chemical entity | 21/07/2010 |
| Cyclizine lactate | Valoid | Link Medical Products Pty Ltd | PM-2010-03573-3-1 | New chemical entity | 15/01/2013 |
| Cyclosporin | Restasis | Allergan Australia Pty Ltd | PM-2009-03746-3-5 | Extension of indications, New dosage form | 22/11/2011 |
D - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Dabigatran etexilate mesilate | Pradaxa | Boehringer Ingelheim Pty Ltd | PM-2010-00120-3-3 | Extension of indications, New strength, Changes to currently approved strengths | 24/05/2011 |
| Dalteparin | Fragmin | Pfizer Australia Pty Ltd | PM-2009-00586-3-3 | Extension of indications | 27/05/2010 |
| Dapagliflozin propanediol monohydrate | Appebb / AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin / Edistride / Empliciti / Forxiga | Bristol-Myers Squibb Australia Pty Ltd | PM-2010-03812-35 | New chemical entity | 14/01/2013 |
| Dapoxetine | Priligy | Janssen-Cilag Pty Ltd | PM-2007-3614-3 | New chemical entity | 23/11/2010 |
| Dasatinib | Sprycel | Bristol-Myers Squibb Australia Pty Ltd | PM-2010-01583-3-4 | Major variation (extension of indications) | 11/07/2011 |
| Deferiprone | Ferriprox | Orphan Australia Pty Ltd | PM-2010-00539-3-4 | Extension of indications, Increase in dosage, Other changes to the Product Information | 04/10/2011 |
| Degarelix | Firmagon | Ferring Pharmaceuticals Pty Ltd | PM-2008-2254-4 | New chemical entity | 16/02/2010 |
| Denosumab | Xgeva | Amgen Australia Pty Ltd | PM-2010-02051-3-4 | New indication, New strength | 30/11/2011 |
| Denosumab | Prolia | Amgen Australia Pty Ltd | PM-2009-00390-3-5 | New biological entity | 26/10/2010 |
| Dexamethasone | Ozurdex | Allergan Australia Pty Ltd | PM-2009-00795-3-5 | New dose form, New route of administration, Extension of indications | 19/10/2011 |
| Dienogest | Visanne | Bayer Australia Ltd | PM-2009-00539-3-5 | Extension of indication | 21/09/2010 |
| Dienogest / Oestradiol valerate | Qlaira | Bayer Australia Limited | PM-2009-02910-3-5 | Extension of indications | 28/03/2011 |
| Dronedarone hydrochloride | Multaq / Dronedarone Winthrop / Dronedarone Sanofi | Sanofi Aventis Australia Pty Ltd | PM-2008-3045-3 | New chemical entity | 05/10/2010 |
| Duloxetine | Cymbalta | Eli Lilly Australia Pty Ltd | PM-2010-03270-3-1 | Extension of Indications | 06/09/2012 |
| Dutasteride | Avodart | GlaxoSmithKline Australia Pty Ltd | PM-2009-02236-3-3 | Extension of indications | 22/09/2010 |
| Dutasteride / Tamsulosin | Duodart | GlaxoSmithKline Australia Pty Ltd | PM-2009-01559-3-3 | New fixed dose combination | 20/10/2010 |
E - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Eformoterol / Budesonide | Symbicort Rapihaler | 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 |
| Eformoterol fumarate dihydrate / Budesonide | Symbicort Turbuhaler 200/6, 400/12 / Symbicort Rapihaler 200/6 | AstraZeneca Pty Ltd | PM-2008-1992-5 | Extension of indications | 20/10/2010 |
| Eltrombopag olamine | Revolade | Glaxo Smith Kline Australia Pty Ltd | SM- 2009-00082-3-4 | New chemical entity | 26/10/2010 |
| Emtricitabine / Tenofovir disoproxil fumarate / rilpivirine | Eviplera | Gilead Sciences Pty Ltd | PM-2010-02853-3-2 | New chemical entity | 27/03/2012 |
| Erlotinib | Tarceva | Roche Products Pty Ltd | PM-2009-00835-3-4 | Extension of indications | 09/11/2010 |
| Erlotinib | Tarceva | Roche Products Pty Limited | PM-2011-01993-3-4 | Extension of Indications | 07/01/2013 |
| Esomeprazole / Aspirin | Axanum | AstraZeneca Pty Ltd | PM-2010-03829-3-3 | New fixed combination | 09/08/2012 |
| Esomeprazole / Naproxen | Vimovo | AstraZeneca Pty Ltd | PM 2010-00846-3-3 | New fixed combination | 09/11/2011 |
| Etanercept | Enbrel | Wyeth Australia Pty Ltd | PM-2008-03723-3-4 | Extension of indications | 16/02/2010 |
| Etanercept | Enbrel | Pfizer Australia Pty Ltd | PM-2010-03845-3-4 | Extension of indications | 19/03/2012 |
| Everolimus | Afinitor | Novartis Pharmaceuticals Australia Pty Ltd | PM-2011-01215-3-4 | Extension of indications | 26/02/2013 |
| Exenatide | Byetta/Bydureon | Eli Lilly Australia Pty Ltd | PM-2010-02389-3-5 | Extension of indication, New dosage form | 05/02/2013 |
| Ezetimibe | Ezetrol | Merck Sharp and Dohme (Australia) Pty Limited | PM-2011-01220-3-3 | Extention of Indication | 28/02/2013 |
| Ezetimibe/Simvastatin | Vytorin | Merck Sharp and Dohme (Australia) Pty Limited | PM-2011-01219-3-1 | Extension of indications | 28/02/2013 |
F - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Fampridine | Fampyra | Biogen Idec Australia Pty Ltd | PM-2010-00524-3-1 | New chemical entity | 15/06/2011 |
| Ferric carboxymaltose | Ferinject | Vifor Pharma Pty Ltd | PM-2009-01623-3-4 | New chemical entity | 24/05/2011 |
| Fibrin adhesive/sealant | Artiss | Baxter Healthcare Pty Ltd | PM-2010-03599-3-4 | Extension of indications | 09/02/2012 |
| Fibrin haemostatic agent/sealant | Evicel | Johnson & Johnson Medical Pty Ltd | PM-2009-03561-3-4 | New Chemical Entity | 11/12/2012 |
| Fibrin sealant | Artiss | Baxter Healthcare Pty Ltd | PM-2009-01572-3-4 | New biological entity | 03/08/2010 |
| Fibrin sealant | Tisseel VH/SD | Baxter Healthcare Pty Ltd | PM-2009-00290-3-4 | Extension of indications | 06/04/2010 |
| Fibrin sealant / adhesive / haemostatic agent | Tisseel VH/SD | Baxter Healthcare Pty Ltd | PM-2010-03271-3-4 | Extension of indications, Additional method of administration | 03/05/2012 |
| Filgrastim | Tevagrastim | Aspen Pharmacare Australia Pty Ltd | PM-2009-1996-3-4 | Similar biological medicinal product | 17/10/2011 |
| Filgrastim | Nivestim | Hospira Pty Ltd | PM-2009-00676-3-4 | New chemical entity (biosimilar product) | 13/09/2010 |
| Fingolimod | Gilenya / Fynefta/ Filosir | Novartis Pharmaceuticals Australia Pty Limited | PM-2010-00401-3-1 | New chemical entity | 29/03/2011 |
| Fish oil / Olive oil / Soya oil / Medium chain triglycerides | SMOFlipid | Fresenius Kabi Australia Pty Ltd | PM-2008-03674-3-1 | New combination | 10/06/2010 |
| Follitropin alfa (rch) / Lutropin alfa (rch) | Pergoveris | Merck Serono Australia Pty Ltd | PM-2008-1439-5 | New fixed combination | 11/01/2010 |
G - AusPARs by active ingredient
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| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Gefitinib | Iressa | AstraZeneca Pty Ltd | PM-2009-02058-3-4 | Extension of indications | 29/06/2010 |
| Glucose 42% / SMOFlipid 20% / Aminoven 10% (with or without electrolytes) | SmofKabiven / SmofKabiven Electrolyte Free Emulsion | Fresenius Kabi Australia Pty Ltd | PM-2010-02110-3-1 | New fixed combination | 15/03/2012 |
| Golimumab | Simponi | Schering-Plough Pty Ltd | PM-2008-1811-3 | New biological entity | 14/12/2009 |
| Gonadotrophin - human menopausal | Menopur | Ferring Pharmaceuticals Pty Limited | PM-2009-01335-3-5 | New chemical entity | 12/10/2011 |
| Granisetron | Sancuso | Invida Australia Pty Ltd | PM-2009-02620-3-4 | New route of administration, New dosage form | 21/06/2011 |
H - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Hib and group C Meningococcal conjugate vaccine | Menitorix | GlaxoSmithKline Australia Pty Ltd | PM-2009-00817-3-2 | New biological entity (new combination vaccine) | 02/08/2010 |
| Human C1 esterase inhibitor | Berinert | CSL Limited, Bioplasma Division | PM-2008-03232-3-2 | New chemical entity | 14/01/2010 |
| Human fibrinogen | RiaSTAP | CSL Limited | PM-2009-01838-3-4 | New chemical entity | 13/10/2010 |
| Human Fibrinogen / Human Thrombin | TachoSil | Nycomed Pty Ltd | PM-2010-02840-3-4 | New fixed combination | 31/08/2012 |
| Human papillomavirus (Types 6, 11, 16 & 18) quadrivalent recombinant vaccine | Gardasil | Merck Sharpe & Dohme (Australia) Pty Limited | PM-2010-03191-3-2 | Extension of indications | 07/05/2012 |
| Human papillomavirus quadrivalent vaccine | Gardasil | Merck Sharp & Dohme (Australia) Pty Ltd | PM-2009-00914-2 | Extension of indications | 08/10/2010 |
| Human Papillomavirus Vaccine Types 16 and 18 (recombinant, AS04 adjuvanted) | Cervarix | GlaxoSmithKline Australia Pty Ltd | PM-2009-02655-3-2 | Major variation (extension of indications) | 22/06/2011 |
| Human Prothrombin Complex | Beriplex P/N | CSL Ltd Bioplasma Division | PM-2008-2935-4 | New chemical entity | 15/01/2010 |
| HumanThrombin / Human Fibrinogen | TachoSil | Nycomed Pty Ltd | PM-2010-02840-3-4 | New fixed combination | 31/08/2012 |
| Hydrochlorothiazide / Aliskiren (as hemifumarate) | Rasilez HCT / Enviage HCT | Novartis Pharmaceuticals Australia Pty Ltd | PM-2008-2072-3 | New fixed combination | 12/03/2010 |
| Hydrochlorothiazide / Aliskiren / Amlodipine | Rasilamlo HCT | Novartis Pharmaceuticals Australia Pty Ltd | PM-2010-02677-3-3 | New combination (of previously approved active ingredients) | 15/06/2012 |
| Hydrochlorothiazide / Valsartan / Amlodipine (as besylate) | Exforge HCT / Ejocia HCT | Novartis Pharmaceuticals Australia Pty Limited | PM-2008-03499-3-3 | New fixed combination | 26/08/2010 |
| Somatropin | Humatrope | Eli Lilly Australia Pty Ltd | PM-2010-00615-3-5 | Extension of Indication | 15/01/2013 |
I - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Ibuprofen | Caldolor | Phebra Pty Ltd | PM-2010-02393-3-1 | Major Variation (New dose form/New route of administration) | 02/01/2013 |
| Icatibant | Firazyr | Shire Australia Pty Ltd | SM-2009-00755-3-2 | New chemical entity | 07/06/2010 |
| Iloperidone | Fanapt | Kendle R&D Pty Limited | PM-2010-02772-3 | New chemical entity | 18/06/2012 |
| Immunoglobulin - normal (human) | Intragam 10 NF | CSL Bioplasma Ltd | PM-2009-01544-3-2 | Extension of indications, New dosage | 18/10/2011 |
| Immunoglobulin - normal (human) | Gamunex | Talecris Biotherapeutics Pty Ltd | PM-2010-01870-3-201870-3-2 | Extension of indications, New route of administration | 13/12/2011 |
| Immunoglobulin - normal (human) | Intratect | Link Medical Products P/L | PM-2009-02495-3-2 | New chemical entity | 03/02/2011 |
| Immunoglobulin - normal (human) | Evogam | CSL Ltd | PM-2010-01887-3-2 | Major variations including New strength, New route of administration, Change in manufacture and tradename | 07/05/2012 |
| Inactivated influenza vaccine / Split virus / Vero cell derived | Preflucel | Baxter Healthcare Pty Ltd | PM-2010-03274-3-2 | New biological entity | 06/07/2012 |
| Indacaterol | Onbrez Breezhaler / Arbeela Breezhaler | Novartis Pharmaceuticals Australia Pty Ltd | PM-2009-00350-3-5 | New chemical entity | 27/10/2010 |
| Indomethacin | Indocid PDA | Invida Australia Pty Ltd | PM-2009-03539-3-3 | Major variation (change in dosage and patient population) | 18/03/2011 |
| Infliximab | Remicade | Janssen-Cilag Pty Ltd | PM-2011-00196-3-1 | Extension of indications | 17/12/2012 |
| Influenza virus haemagglutinin (Type A/California/7/2009 (H1N1)v-like strain adjuvanted to ASO3) | Pandemrix H1N1 pandemic influenza vaccine | GlaxoSmithKline Australia Pty Ltd | PM-2010-02995-3-2 | Major variation: Change in patient group and dosing schedule. | 12/02/2013 |
| Influenza Virus Haemagglutinin H5N1 | Aflunov / Prepandemic H5N1 adjuvanted Influenza Vaccine | Novartis Vaccines and Diagnostics | PM-2009-03929-3-2 | New biosimilar medicine similar to other pandemic and seasonal influenza vaccines | 06/07/2011 |
| Iodixanol | Visipaque | GE Healthcare Australia Pty Ltd | PM-2009-00811-3-2 | Extension of indications | 14/05/2010 |
| Ipilimumab | Yervoy / Winglore | Bristol-Myers Squibb Australia Pty Ltd | PM-2010-02212-3-4 | New biological entity | 10/08/2011 |
| Ivabradine | Coralan | Servier Laboratories (Australia) Pty Ltd | PM-2008-2832-3 | Extension of indications | 03/09/2010 |
| Ivabradine | Coralan | Servier Laboratories (Australia) Pty Ltd | PM-2010-03269-3-3 | Major Variation (Extension of indications) | 31/10/2012 |
J - AusPARs by active ingredient
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| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Japanese Encephalitis Chimeric Virus | Imojev | Sanofi Pasteur Pty Ltd | PM-2009-01554-3-2 | New chemical entity | 16/08/2010 |
K - AusPARs by active ingredient
There are no published AusPARs where the active ingredient begins with 'k'.
L - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Lanthanum carbonate | Fosrenol | Shire Australia Pty Limited | PM-2010-01654-3-3 | Extension of indications | 14/02/2012 |
| Lapatinib | Tykerb | GlaxoSmithKline Australia Pty Ltd | PM-2009-01276-3-4 | Extension of indications | 17/06/2010 |
| Lapatinib | Tykerb | GlaxoSmithKline Australia Pty Ltd | PM-2011-00908-3-4 | Extension of indications | 12/11/2012 |
| Leuprorelin acetate | Lucrin Depot / Lucrin XL Depot | Abbott Australasia Pty Ltd | PM-2009-00544-3-4 | New strength, New route of administration | 30/07/2010 |
| Linagliptin | Trajenta | Boehringer Ingleheim (Australia) Pty Ltd | PM-2010-02400-3-5 | New chemical entity | 12/12/2011 |
| Liraglutide (rys) | Victoza | Novo Nordisk Pharmaceuticals Pty Limited | PM-2008-2113-5 | New biological entity | 22/11/2010 |
| Lutropin alfa (rch) / Follitropin alfa (rch) | Pergoveris | Merck Serono Australia Pty Ltd | PM-2008-1439-5 | New fixed combination | 11/01/2010 |
M - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Mannitol | Bronchitol | Pharmaxis Ltd | PM-2009-03748-3-5 | Extension of indications | 29/03/2011 |
| Medium chain triglycerides / Olive oil / Fish oil / Soya oil | SMOFlipid | Fresenius Kabi Australia Pty Ltd | PM-2008-03674-3-1 | New combination | 10/06/2010 |
| Medroxyprogesterone acetate | Sayana | Pfizer Australia Pty Ltd | PM-2009-03498-3-5 | Major variation (new route of administration) | 27/07/2011 |
| Melatonin | Circadin | Commercial Eyes Pty Ltd | PM-2008-2125-1 | New chemical entity | 28/11/2009 |
| Melatonin | Circadin | RAD Data Australia Pty Ltd | PM-2010-01756-3-1 | Extension of indications | 18/01/2011 |
| Meningococcal conjugate vaccine Group C and Hib | Menitorix | GlaxoSmithKline Australia Pty Ltd | PM-2009-00817-3-2 | New biological entity (new combination vaccine) | 02/08/2010 |
| Meningococcal conjugated vaccine | Menveo | Novartis Vaccines and Diagnostics Pty Ltd | SM-2009-00001-3-2 | New chemical entity | 20/05/2010 |
| Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine - Groups A, C, Y and W-135 | Menactra | Sanofi Pasteur Pty Ltd | PM-2010-00277-3-5 | New chemical entity | 31/08/2011 |
| Metformin hydrochloride / Vildagliptin | Galvumet / Sobrea | Novartis Pharmaceuticals Australia Pty Ltd | PM-2009-00972-3-5 | New fixed combination | 07/12/2010 |
| Metformin/Sitagliptin | Janumet | Merck Sharpe and Dohme (MSD) Australia Pty Ltd | PM-2011-01226-3-5 | Extension of Indications | 14/01/2013 |
| MF59C.1 adjuvanted / Trivalent seasonal influenza vaccine, inactivated | Fluad Paediatric | Novartis Vaccines and Diagnostics Pty Ltd | PM-2010-03905-3-2 | New biological entity | 04/10/2012 |
| Mifepristone | Mifepristone Linepharma | MS Health | PM-2010-02694-3-5 | New chemical entity | 02/10/2012 |
| Miglustat | Zavesca | Actelion Pharmaceuticals Australia Pty Ltd | PM-2008-3187-1 | Extension of indications | 09/03/2010 |
| Milnacipran | Joncia | Pierre Fabre Medicament Australia Pty Ltd | PM-2011-02708-3-1 | New chemical entity | 24/01/2012 |
| Misoprostol | GyMiso | MS Health | PM-2011-01625-3-5 | Extension of indications | 02/10/2012 |
N - AusPARs by active ingredient
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| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Naloxone / Buprenorphine | Suboxone Sublingual Film | Reckitt Benckiser (Australia) Pty Ltd | PM-2009-01902-3-1 | New dose form | 07/12/2010 |
| Naloxone hydrochloride / Oxycodone hydrochloride | Targin | Mundipharma Pty Ltd | PM-2008-2938-1 | New fixed combination | 04/05/2010 |
| Naproxen / Esomeprazole | Vimovo | AstraZeneca Pty Ltd | PM 2010-00846-3-3 | New fixed combination | 09/11/2011 |
| Nevirapine | Viramune XR | Boehringer Ingelheim Pty Ltd | PM-2010-03093-3-2 | New dosage form | 19/03/2012 |
| Nilotinib | Tasigna | Novartis Pharmaceuticals Australia Pty Ltd | PM-2010-01053-3-4 | Extension of indications, New strength | 04/10/2011 |
| Nitisinone | Orfadin | Orphan Australia Pty Ltd | PM-2009-02266-3-3 | New chemical entity | 15/10/2010 |
| Nomegestrol acetate / Oestradiol | Zoely | Merck Sharp & Dohme (Australia) Pty Limited | PM-2010-00254-3-5 | New chemical entity | 04/10/2011 |
| Norethisterone acetate / Oestradiol | Kliovance Low | Novo Nordisk Pharmaceuticals Pty Ltd | PM-2010-00087-5-3 | New strength | 18/01/2012 |
O - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Ocreotide | Sandostatin LAR | Novartis Pharmaceuticals Australia Pty Ltd | PM-2010-03092-3-4 | Extension of indications | 14/02/2012 |
| Oestradiol / Nomegestrol acetate | Zoely | Merck Sharp & Dohme (Australia) Pty Limited | PM-2010-00254-3-5 | New chemical entity | 04/10/2011 |
| Oestradiol / Norethisterone acetate | Kliovance Low | Novo Nordisk Pharmaceuticals Pty Ltd | PM-2010-00087-5-3 | New strength | 18/01/2012 |
| Oestradiol valerate / Dienogest | Qlaira | Bayer Australia Limited | PM-2009-02910-3-5 | Extension of indications | 28/03/2011 |
| Ofatumumab | Arzerra | GlaxoSmithKline Australia Pty Ltd | PM-2009-02159-3-4 | New biological entity | 15/12/2010 |
| Olive oil / Fish oil / Soya oil / Medium chain triglycerides | SMOFlipid | Fresenius Kabi Australia Pty Ltd | PM-2008-03674-3-1 | New combination | 10/06/2010 |
| Olmesartan medoxomil | Olmetec | Merck Sharp & Dohme (Australia) Pty Ltd | PM-2011-01941-3-3 | Major Variation (New Dosage Form, Increase in Patient Group) | 26/02/2013 |
| Olmesartan medoxomil / Amlodipine besylate | Sevikar | Schering-Plough Pty Ltd | PM-2008-03320-3-3 | New fixed dose combination | 21/09/2010 |
| Omega-3-acid ethyl esters 90 | Omacor | Abbott Products Pty Ltd | PM-2008-3043-3 | New chemical entity | 28/07/2010 |
| Oseltamivir phosphate | Tamiflu | Roche Products Pty Ltd | PM-2010-00616-3-2 | Major variation (extension of indications/new population) | 27/07/2011 |
| Oxaliplatin / Capecitabine | Eloxatin / Oxaliplatin Dakota / Winthrop Oxaliplatin / Xeloda | 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 |
| Oxycodone hydrochloride / Naloxone hydrochloride | Targin | Mundipharma Pty Ltd | PM-2008-2938-1 | New fixed combination | 04/05/2010 |
P - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Paliperidone | Invega | Janssen-Cilag Pty Ltd | PM-2009-00515-3-1 | Extension of indications | 14/12/2009 |
| Paliperidone palmitate | Invega Sustenna | Janssen-Cilag Australia Pty Ltd | PM-2009-00926-3-1 | New salt of a previously approved active ingredient | 20/07/2010 |
| Pancreatic extract | Creon Micro | Abbott Products Pty Ltd | PM-2009-02729-3-1 | New formulation | 28/09/2010 |
| Pandemic influenza vaccine | Arepanrix H5N1 | GSK Australia Pty Ltd | PM-2009-03131-3-2 | New biological entity | 01/02/2011 |
| Pandemic influenza vaccine | Pandemic Influenza Vaccine H5N1 Baxter | Baxter Healthcare Pty Ltd | PM-2008-1961-2 | New biological entity | 09/12/2010 |
| Pandemrix | Pandemic H1N1 influenza vaccine | GlaxoSmithKline Australia Pty Ltd | PM-2009-03526-3-2 | Major variation | 20/10/2010 |
| Panitumumab | Vectibix | Amgen Australia Pty Ltd | PM-2010-01972-3-4 | Major variation (extension of indications) | 07/05/2012 |
| Paracetamol / Tramadol hydrochloride | Zaldiar | Grunenthal Pty Ltd | PM-2010-3272-3-1 | New fixed combination | 13/09/2012 |
| Pazopanib hydrochloride | Votrient | GlaxoSmithKline Australia Pty Ltd | PM-2009-01084-4 | New chemical entity | 01/09/2010 |
| Peginterferon alfa-2a / Ribavirin | Pegasys RBV / Pegasys / Copegus | Roche Australia Pty Ltd | PM-2010-00382/00415/00416-3-2 | Major variation | 15/06/2011 |
| Perindopril arginine / Amlodipine (as besylate) | Coveram | Servier Laboratories (Aust) Pty Ltd | PM-2008-2262-3 | New combination | 13/11/2009 |
| Plerixafor | Mozobil | Genzyme Australasia Pty Ltd | SM-2008-03602-4 | New chemical entity | 23/07/2010 |
| Pneumococcal Polysaccharide Conjugate Vaccine | Prevenar 13 | Wyeth Australia Pty Ltd | PM-2009-00110-3-2 | New biological entity | 13/05/2010 |
| Pneumococcal Polysaccharide Conjugate Vaccine 13 valent | Prevenar 13 | Pfizer Australia Pty Ltd | PM-2010-03262-3-2 | Extension of indications, Changes to the Product Information | 13/12/2011 |
| Pneumococcal polysaccharide conjugate vaccine, 10-valent adsorbed | Synflorix | GlaxoSmithKline Pty Ltd | PM-2010-02793-3-2 | Major Variation (Extension of Indication) | 22/10/2012 |
| Prucalopride | Resotrans | Janssen-Cilag Pty Ltd | PM-2010-03060-3-1 | New chemical entity | 23/11/2011 |
Q - AusPARs by active ingredient
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| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Quetiapine (as fumarate) | Seroquel, Seroquel XR | AstraZeneca Pty Ltd | PM-2008-03436-1 | Extension of indications | 13/04/2010 |
R - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Ranibizumab | Lucentis | Novartis Pharmaceuticals Australia Pty Ltd | PM-2010-03258-3-5 | Extension of indications, Changes to Product Information | 01/12/2011 |
| Ranibizumab | Lucentis | Novartis Pharmaceuticals Australia Pty Ltd | PM-2010-02527-3-5 | Extension of indications | 09/11/2011 |
| Rasagiline | Azilect | Lundbeck Australia Pty Ltd | PM-2010-00798-3-1 | New chemical entity | 08/02/2012 |
| Remifentanil (as hydrochloride) | Ultiva | GlaxoSmithKline Australia Pty Ltd | PM-2011-00909-3-1 | Major variation: New mode of administration | 29/01/2013 |
| Ribavirin / Peginterferon alfa-2a | Pegasys RBV / Pegasys / Copegus | Roche Australia Pty Ltd | PM-2010-00382/00415/00416-3-2 | Major variation | 15/06/2011 |
| Rifaximin | Xifaxan | Norgine Pty Ltd | PM-2011-00501-3-1 | New Chemical Entity | 19/11/2012 |
| Rilpivirine | Edurant | Janssen-Cilag Pty Ltd | PM-2010-03030-3-2 | New chemical entity | 27/03/2012 |
| Rilpivirine / Tenofovir disoproxil fumarate / emtricitabine | Eviplera | Gilead Sciences Pty Ltd | PM-2010-02853-3-2 | New chemical entity | 27/03/2012 |
| Risperidone | Risperdal Consta | Janssen-Cilag Pty Ltd | PM-2008-03495-3-1 | Extension of indications | 18/06/2010 |
| Rituximab | MabThera | Roche Products Pty Ltd | PM-2009-00656-3-4 | Extension of indications | 19/02/2010 |
| Rituximab | MabThera | Roche Products Pty Ltd | PM-2010-01845-3-4 | New dosage regimen | 09/12/2011 |
| Rituximab | MabThera | Roche Products Pty Ltd | PM-2009-01744-3-3 | Extension of indications, Broaden patient population | 06/05/2010 |
| Rivaroxaban | Xarelto | Bayer Australia Ltd | PM-2010-03901-3-3 | Extension of indications | 13/09/2012 |
| Roflumilast | Daxas / Xevex / Dalveza | Nycomed Pty Ltd | PM-2009-02915-3-5 | New chemical entity | 20/12/2011 |
| Ropivacaine | Naropin | AstraZeneca Pty Ltd | PM-2009-01406-3-1 | Extension of indications | 23/04/2010 |
| Rosuvastatin | Crestor / Visacor | AstraZeneca Pty Ltd | PM-2009-01470-3-3 | Extension of indications | 25/05/2011 |
| Rotigotine | Neupro | UCB Australia Pty Ltd | PM-2009-01999-3-1 | Extension of indications, Registration of two new strengths | 08/10/2010 |
| Rupatadine | Rupafin | iNova Pharmaceuticals (Australia) Pty Ltd | PM-2009-03232-3-5 | New chemical entity | 18/05/2011 |
S - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Sapropterin dihydrochloride | Kuvan | Merck Serono Australia Pty Ltd | PM-2009-02891-3-3 | New chemical entity | 21/10/2010 |
| Saxagliptin | Onglyza | Bristol-Myers Squibb / AstraZeneca | PM-2010-03800-3-5 | Major variation (new strength, new patient group, change in dosage) | 25/06/2012 |
| Saxagliptin hydrochloride | Onglyza | Bristol-Myers Squibb Australia Pty Ltd | PM-2008-03469-3-5 | New chemical entity | 13/04/2011 |
| Sildenafil | Revatio | Pfizer Australia Pty Ltd | PM-2010-00912-3-3 | Extension of indications, Major variation | 12/10/2011 |
| Sildenafil | Revatio | Pfizer Australia Pty Ltd | PM-2010-00820-3-3 | Extension of indications | 19/10/2011 |
| Simvastatin/Ezetimibe | Vytorin | Merck Sharp and Dohme (Australia) Pty Limited | PM-2011-01219-3-1 | Extension of indications | 28/02/2013 |
| Sitagliptin (as phosphate monohydrate) | Januvia | MSD (Australia) Pty Limited | PM 2011-01224-3-5 | Extension of indications | 20/12/2012 |
| Sitagliptin/Metformin | Janumet | Merck Sharpe and Dohme (MSD) Australia Pty Ltd | PM-2011-01226-3-5 | Extension of Indications | 14/01/2013 |
| SMOFlipid 20% / Aminoven 10% (with or without electrolytes) / glucose 42% | SmofKabiven / SmofKabiven Electrolyte Free Emulsion | Fresenius Kabi Australia Pty Ltd | PM-2010-02110-3-1 | New fixed combination | 15/03/2012 |
| Somatropin | Genotropin | Pfizer Australia | PM-2008-2730-5 | Product information change, requiring the evaluation of clinical, non-clinical or bioequivalence data | 09/03/2010 |
| Somatropin | Humatrope | Eli Lilly Australia Pty Ltd | PM-2010-00615-3-5 | Extension of Indication | 15/01/2013 |
| Somatropin | Zomacton | Ferring Pharmaceuticals Pty Ltd | PM-2008-2954-5 | Major variation (New strength/New mode of administration) | 01/12/2010 |
| Soya oil / Medium chain triglycerides / Olive oil / Fish oil | SMOFlipid | Fresenius Kabi Australia Pty Ltd | PM-2008-03674-3-1 | New combination | 10/06/2010 |
| Split virus / Vero cell derived / Inactivated influenza vaccine | Preflucel | Baxter Healthcare Pty Ltd | PM-2010-03274-3-2 | New biological entity | 06/07/2012 |
| Strontium ranelate | Protos | Servier Laboratories (Australia) Pty Ltd | PM-2011-00498-3-5 | Extension of indications | 07/01/2013 |
| Sunitinib | Sutent | Pfizer Australia Pty Ltd | PM-2010-01205-4 | Extension of indications, New dosage | 29/06/2011 |
T - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Tacrolimus | Prograf-XL | Janssen-Cilag Pty Ltd | PM-2008-03783-3-2 | New dosage form | 06/05/2010 |
| Tadalafil | Adcirca | Eli Lilly Australia Pty Ltd | PM-2010-01829-3-3 | Extension of indications and additional trade name | 20/09/2011 |
| Tafluprost | Saflutan | Merck Sharp & Dohme (Australia) Pty Ltd | PM-2009-3896-5 | New chemical entity | 03/05/2012 |
| Tamsulosin / Dutasteride | Duodart | GlaxoSmithKline Australia Pty Ltd | PM-2009-01559-3-3 | New fixed dose combination | 20/10/2010 |
| Tapentadol | Palexia IR | CSL Ltd | PM-2009-02488-3-1 | New chemical entity | 17/11/2010 |
| Tapentadol | Palexia SR | CSL Ltd | PM-2009-02489-3-1 | New chemical entity | 28/02/2011 |
| Telaprevir | Incivo | Janssen-Cilag Pty Ltd | Janssen-Cilag Pty Ltd | New chemical entity | 26/10/2012 |
| Telmisartan | Micardis / Pritor | Boehringer Ingelheim Pty Ltd | PM-2009-00165-3-3 | Extension of indications | 22/04/2010 |
| Telmisartan / Amlodipine | Twynsta | Boehringer Ingelheim Pty Ltd | PM-2009-03138-3-3 | New fixed dose combination | 14/02/2011 |
| Tenofovir disoproxil fumarate / emtricitabine / rilpivirine | Eviplera | Gilead Sciences Pty Ltd | PM-2010-02853-3-2 | New chemical entity | 27/03/2012 |
| Teriparatide | Forteo | Eli Lilly Australia Pty Ltd | PM-2009-02138-3-5 | Major variation (extension of treatment duration) | 07/09/2010 |
| Terlipressin acetate | Glypressin | Ferring Pharmaceuticals Pty Ltd | PM-2010-03182-3-3 | New Chemical Entity | 26/11/2012 |
| Ticagrelor | Brilinta | AstraZeneca Pty Ltd | PM-2009-03523-3-3 | New chemical entity | 12/07/2011 |
| Timolol Maleate / Brinzolamide | Azarga | Alcon Laboratories (Australia) Pty Ltd | PM-2008-3124-5 | New fixed combination | 19/02/2010 |
| Tobramycin inhalation powder | TOBI Podhaler | Novartis Pharmaceuticals Australia Pty Ltd | PM-2011-00135-3-2 | New dosage form | 26/10/2012 |
| Tocilizumab | Actemra | Roche Products Pty Ltd | PM-2009-03295-3-3 | Extension of indications | 13/01/2011 |
| Tocilizumab | Actemra | Roche Products Pty Ltd | PM-2010-03070-3-3 | Extension of indications | 06/12/2011 |
| Tolvaptan | Samsca | Orphan Australia Pty Ltd | PM-2010-02939-3-5 | New chemical entity | 04/10/2012 |
| Trabectedin | Yondelis | Janssen-Cilag Pty Ltd | PM-2009-01976-3-4 | New chemical entity | 09/11/2010 |
| Tramadol hydrochloride / Paracetamol | Zaldiar | Grunenthal Pty Ltd | PM-2010-3272-3-1 | New fixed combination | 13/09/2012 |
| Tranexamic acid | Cyklokapron | Pfizer Australia Pty Ltd | PM-2009-00587 | Extension of indications, New dosage form | 10/09/2010 |
| Trastuzumab | Herceptin | Roche Products Pty Ltd | 2011-01528-3-4 | Extension of indications | 17/12/2012 |
| Trastuzumab | Herceptin | Roche Products Pty Ltd | PM-2009-03121 | Major variation (extension of indications) | 17/09/2010 |
| Trivalent seasonal influenza vaccine, inactivated / MF59C.1 adjuvanted | Fluad Paediatric | Novartis Vaccines and Diagnostics Pty Ltd | PM-2010-03905-3-2 | New biological entity | 04/10/2012 |
U - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Ursodeoxycholic acid | Urso / Ursofalk | Orphan Australia Pty Ltd | PM-2008-03582-3-1 | Extension of indications, Change of dosage | 28/07/2010 |
V - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Valsartan / Amlodipine | Exforge/Ejocia 10/320; Exforge/Ejocia 5/320 | Novartis Pharmaceuticals Australia Pty Ltd | PM-2009-01168-3-3 | Major variation (new strength) | 26/07/2010 |
| Valsartan / Amlodipine (as besylate) / Hydrochlorothiazide | Exforge HCT / Ejocia HCT | Novartis Pharmaceuticals Australia Pty Limited | PM-2008-03499-3-3 | New fixed combination | 26/08/2010 |
| Vardenafil | Levitra | Bayer Australia Ltd | PM-2009-02689-3-3 | New dosage form and change in dosage instructions | 12/01/2011 |
| Velaglucerase alfa (ghu) | VPRIV | Shire Australia Pty Ltd | PM-2010-03810-3-3 | New chemical entity (biological) | 07/05/2012 |
| Vemurafenib | Zelboraf | Roche Products Pty Limited | PM-2011-00795-3-4 | New Chemical Entity | 17/12/2012 |
| Vernakalant | Brinavess | Merck Sharpe & Dohme (Australia) Pty Ltd | PM-2010-01025-3-3 | New chemical entity | 12/11/2012 |
| Vero cell derived / Inactivated influenza vaccine / Split virus | Preflucel | Baxter Healthcare Pty Ltd | PM-2010-03274-3-2 | New biological entity | 06/07/2012 |
| Vildagliptin | Galvus / Xiliarx | Novartis Pharmaceuticals Australia Pty Ltd | PM-2009-00158-3-5 | New chemical entity | 23/02/2010 |
| Vildagliptin / Metformin hydrochloride | Galvumet / Sobrea | Novartis Pharmaceuticals Australia Pty Ltd | PM-2009-00972-3-5 | New fixed combination | 07/12/2010 |
| Vinflunine ditartrate | Javlor | Pierre Fabre Medicament Australia Pty Ltd | PM-2009-03102-3-4 | New chemical entity | 07/02/2011 |
| Vinorelbine | Navelbine | Pierre Fabre Medicament Australia Pty Ltd | PM-2010-03252-3-4 | Extension of indications | 30/05/2012 |
W - AusPARs by active ingredient
There are no published AusPARs where the active ingredient begins with 'w'.X - AusPARs by active ingredient
There are no published AusPARs where the active ingredient begins with 'x'.Y - AusPARs by active ingredient
There are no published AusPARs where the active ingredient begins with 'y'.Z - AusPARs by active ingredient
Hint: Click on the table headers to sort the table by a particular column in ascending or descending order.
| Active ingredient | Proprietary product name | Sponsor | Submission no. | Submission type | AusPAR date |
|---|---|---|---|---|---|
| Ziprasidone mesilate | Zeldox IM | Pfizer Australia Pty Ltd | PM-2008-1737-1 | New dosage form | 18/12/2009 |
| Zoledronic acid | Aclasta / Osteovan | Novartis Australia Pty Ltd | PM-2010-01920-3-5 | Major variation | 31/08/2011 |
Content last updated: Monday, 29 April 2013
Content last reviewed: Monday, 29 April 2013
Web page last updated: Wednesday, 1 May 2013
URL: http://www.tga.gov.au/industry/pm-auspar-active.htm