Browse AusPARs by product name

Australian Public Assessment Reports for prescription medicines

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 version of the Product Information for that prescription medicine which was approved with the submission which the AusPAR describes. Product Information may have been updated since the AusPAR was prepared. For the current Product Information for a medicine please see: Product Information (PI).

A

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Abasria / Abasria KwikPen Insulin glargine Eli Lilly Australia Pty Ltd PM-2013-02802-1-5 Biosimilar (Insulin analogue) 20/08/15
Abilify Aripiprazole Bristol-Myers Squibb Pharmaceuticals Pty Ltd PM-2010-00571-3-1 Extension of indications 03/03/11
Abilify maintena Aripiprazole monohydrate Lundbeck (Australia) Pty Ltd PM-2013-01100-1-1 Major variation (new strength, new dosage form) 25/11/14
Abraxane Nanoparticle albumin-bound (nab) paclitaxel Abraxis BioScience Australia Pty Ltd PM-2012-01185-3-4 Extension of indications 09/01/14
Abraxane Nanoparticle albumin-bound (nab) paclitaxel Abraxis BioScience Australia Pty Ltd PM-2013-01523-1-4 Extension of indications 17/06/14
Abstral Fentanyl citrate A. Menarini Australia Pty Ltd PM-2011-03151-3-1 Major variation (new dosage form) 30/10/13
Aclasta / Osteovan Zoledronic acid Novartis Australia Pty Ltd PM-2010-01920-3-5 Major variation 31/08/11
Actair initiation treatment, Actair continuation treatment American house dust mite / European house dust mite Stallergenes Australia Pty Ltd PM-2014-03871-1-2 Major variation (new dosage form and new route of administration) 09/08/17
Actair initiation treatment, Actair continuation treatment European house dust mite / American house dust mite Stallergenes Australia Pty Ltd PM-2014-03871-1-2 Major variation (new dosage form and new route of administration) 09/08/17
Actemra Tocilizumab Roche Products Pty Ltd PM-2009-03295-3-3 Extension of indications 13/01/11
Actemra Tocilizumab Roche Products Pty Ltd PM-2010-03070-3-3 Extension of indications 06/12/11
Actemra Tocilizumab Roche Products Pty Ltd PM-2012-01905-3-3 Extension of indications 06/02/14
Actemra Tocilizumab (rch) Roche Products Pty Ltd PM-2013-02398-1-3 Major variation (extension of indications) 13/01/15
Actemra Tocilizumab (rch) Roche Products Pty Ltd PM-2014-04309-1-3 Major variation (new dosage form, new dose, new strength and new route of administration) 29/09/16
Actilyse Alteplase Boehringer Ingelheim Pty Limited PM-2009-02729-3-1 Extension of indications 28/09/10
Adcetris Brentuximab vedotin Takeda Pharmaceuticals Australia Pty Ltd PM-2012-03441-1-4 New chemical entity 19/05/14
Adcetris Brentuximab vedotin Takeda Pharmaceuticals Australia Pty Ltd PM-2015-01529-1-4 Extension of indications 14/09/17
Adcirca Tadalafil Eli Lilly Australia Pty Ltd PM-2010-01829-3-3 Extension of indications, Additional trade name 20/09/11
Addaven Nine trace elements including chromic chloride Fresenius Kabi Australia Pty Ltd PM-2015-01467-1-1 New chemical entity 23/03/17
Adempas Riociguat Bayer Australia Limited PM-2013-00307-1-3 New chemical entity 12/06/14
Adenuric Febuxostat (FBX) A Menarini Australia Pty Ltd PM-2012-03425-1-3 New chemical entity 08/01/15
Afinitor Everolimus Novartis Pharmaceuticals Australia Pty Limited PM-2011-01215-3-4 Extension of indications 26/02/13
Afinitor Everolimus Novartis Pharmaceuticals Australia Pty Limited PM-2012-00337-3-4 Extension of indications 22/08/13
Aflitiv / Lidaveg / Zaltrap Aflibercept (rch) Sanofi-Aventis Australia Pty Ltd PM-2011-04301-3-4 New biological entity 29/07/13
Aflunov / Prepandemic H5N1 adjuvanted Influenza Vaccine Influenza Virus Haemagglutinin H5N1 Novartis Vaccines and Diagnostics Pty Ltd PM-2009-03929-3-2 New biosimilar medicine similar to other pandemic and seasonal influenza vaccines 06/07/11
Afluria Quad Inactivated quadrivalent influenza vaccine (split virion) Seqirus Pty Ltd PM-2015-02796-1-2 New chemical/biological entity 20/07/17
Afolia / Bemfola Follitropin alfa (rch) Finox Biotech Australia Pty Ltd PM-2014-03163-1-5 Biosimilar medicine, Extension of indications 08/04/16
Akynzeo Netupitant / Palonosetron (as hydrochloride) Specialised Therapeutics Australia Pty Ltd PM-2014-00341-1-4 New chemical entity, New fixed dose combination 28/10/16
Akynzeo Palonosetron (as hydrochloride) / Netupitant Specialised Therapeutics Australia Pty Ltd PM-2014-00341-1-4 New chemical entity, New fixed dose combination 28/10/16
Albumex 20 / Albumex 5 / Albumex 4 Albumin (human) CSL Limited PM-2010-02082-3-5 Extension of indications 27/07/11
Albunate 20 / Albunate 25 / Albunate 5 Albumin (human) CSL Limited PM-2014-01051-1-5 New biological medicine 02/05/17
Albunate 25, Albunate 5 and Albunate 20 Albumin (human) CSL Limited PM-2014-01051-1-5 New biological medicine 02/05/17
Albunate 5 / Albunate 20 / Albunate 25 Albumin (human) CSL Limited PM-2014-01051-1-5 New biological medicine 02/05/17
Alendraccord / Alendrocor / Pharmacor Alendronate Alendronic acid Accord Healthcare Pty Ltd PM-2009-01135-3-5 New generic 16/02/11
Aloxi Palonosetron hydrochloride Specialised Therapeutics Australia Pty Ltd PM-2012-02735-3-4 Major variation (dosage) 07/01/14
Alphagan P / Enidin P Brimonidine tartrate Allergan Australia Pty Ltd PM-2008-03768-3-5 New strength, Change in formulation, New trade names 24/05/10
Alprolix Eftrenonacog alfa Biogen Idec Australia Pty Ltd PM-2013-00745-1-4 New biological entity 03/11/14
Altargo Retapamulin GlaxoSmithKline Australia Pty Ltd PM-2012-01489-3-2 New chemical entity 11/11/13
Ano-Cream Diltiazem hydrochloride AFT Pharmaceuticals Pty Ltd PM-2015-01099-1-1 Major variation (new dosage form) 10/05/17
Anoro Ellipta Vilanterol trifenatate and Umeclidinium bromide GlaxoSmithKline Australia Pty Ltd PM-2013-00332-1-5 New fixed dose combination 08/04/15
Anoro Ellipta Umeclidinium bromide and Vilanterol trifenatate GlaxoSmithKline Australia Pty Ltd PM-2013-00332-1-5 New fixed dose combination 08/04/15
Antizol Fomepizole AFT Pharmaceuticals Pty Ltd PM-2015-02803-1-3 New chemical entity 17/08/17
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 14/01/13
Arbeela Breezhaler / Onbrez Breezhaler Indacaterol Novartis Pharmaceuticals Australia Pty Limited PM-2009-00350-3-5 New chemical entity 27/10/10
Arepanrix H5N1 Pandemic influenza vaccine GSK Australia Pty Ltd PM-2009-03131-3-2 New biological entity 01/02/11
Artiss Fibrin adhesive/sealant Baxter Healthcare Pty Ltd PM-2010-03599-3-4 Extension of indications 09/02/12
Artiss Fibrin sealant Baxter Healthcare Pty Ltd PM-2009-01572-3-4 New biological entity 03/08/10
Arzerra Ofatumumab GlaxoSmithKline Australia Pty Ltd PM-2009-02159-3-4 New biological entity 15/12/10
Aspen Thyroxine, Eltroxin, Thyroxine Aspen Thyroxine sodium Aspen Pharma Pty Ltd PM-2012-04477-1-5 New generic, New strength 12/06/14
Atozet / Zeteze Ezetimibe / Atorvastatin Merck Sharp & Dohme (Australia) Pty Limited PM-2015-04334-1-3 Extension of indications 11/07/17
Atozet Composite Pack/Zeteze Composite Pack Ezetimibe + atorvastatin as calcium Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-04091-3-3 New fixed dose combination 28/05/13
Atozet, Zeteze Ezetimibe / Atorvastatin Merck Sharp & Dohme Australia Pty Ltd PM-2013-03231-1-3 New combination of active ingredients 07/08/15
Atozet, Zeteze Atorvastatin / Ezetimibe Merck Sharp & Dohme Australia Pty Ltd PM-2013-03231-1-3 New combination of active ingredients 07/08/15
Aubagio / Teriflunomide Winthrop / Teriflunomide Sanofi Teriflunomide Sanofi-Aventis Australia Pty Ltd PM-2011-02772-3-1 New chemical entity 21/05/13
Avastin Bevacizumab Roche Products Pty Ltd PM-2009-00515-3-1 Extension of indications 14/12/09
Avastin Bevacizumab Roche Products Pty Ltd PM-2010-3786-3-4 Extension of indications 06/08/12
Avastin Bevacizumab (recombinant humanised) Roche Products Pty Ltd PM-2011-02308-3-4 Extension of indications 07/03/13
Avastin Bevacizumab injection Roche Products Pty Ltd PM-2012-02716-3-4 Major variation (dosage) 31/03/14
Avastin Bevacizumab Roche Products Australia Pty Ltd PM-2013-00709-1-4 Major variation (extension of indications) 03/11/14
Avastin Bevacizumab Roche Products Pty Ltd PM-2013-03227-1-4 Extension of indications 11/03/15
Avastin Bevacizumab (rch) Roche Products Pty Ltd PM-2014-01871-1-4 Major variation (new indication) 10/05/17
Avodart Dutasteride GlaxoSmithKline Australia Pty Ltd PM-2009-02236-3-3 Extension of indications 22/09/10
Axanum Aspirin / Esomeprazole AstraZeneca Pty Ltd PM-2010-03829-3-3 New fixed combination 09/08/12
Axanum Esomeprazole / Aspirin AstraZeneca Pty Ltd PM-2010-03829-3-3 New fixed combination 09/08/12
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 14/01/13
Azarga Brinzolamide / Timolol Maleate Alcon Laboratories (Australia) Pty Ltd PM-2008-3124-5 New fixed combination 19/02/10
Azarga Timolol Maleate / Brinzolamide Alcon Laboratories (Australia) Pty Ltd PM-2008-3124-5 New fixed combination 19/02/10
Azilect Rasagiline Lundbeck Australia Pty Ltd PM-2010-00798-3-1 New chemical entity 08/02/12

B

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Belkyra Deoxycholic acid Allergan Australia Pty Ltd PM-2014-04251-1-5 New chemical entity 06/04/17
Belsomra Suvorexant Merck Sharp and Dohme Australia Pty Ltd PM-2013-00325-1-1 New chemical entity 11/03/15
Bemfola / Afolia Follitropin alfa (rch) Finox Biotech Australia Pty Ltd PM-2014-03163-1-5 Biosimilar medicine, Extension of indications 08/04/16
Benlysta Belimumab GlaxoSmithKline Australia Pty Ltd PM-2010-01980-3-2 New biological entity 31/10/12
Berinert Human C1 esterase inhibitor CSL Limited, Bioplasma Division PM-2008-03232-3-2 New chemical entity 14/01/10
Beriplex P/N Human Prothrombin Complex CSL Limited, Bioplasma Division PM-2008-2935-4 New chemical entity 15/01/10
Besivance Besifloxacin hydrochloride Bausch & Lomb (Australia) Pty Ltd PM-2012-02740-3-2 New chemical entity 03/02/14
Betmiga Mirabegron Astellas Pharma Australia Pty Ltd PM-2012-01928-3-3 New chemical entity 09/01/14
Bexsero Multi-Component Meningococcal B vaccine Novartis Vaccines and Diagnostics Pty Ltd PM-2011-02486-3-2 New chemical entity 31/10/13
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 14/01/13
Botox Botulinum toxin type A Allergan Australia Pty Ltd PM-2012-01467-3-3 Major variation (extension of indications) 23/10/13
Botox Botulinum toxin type A Allergan Australia Pty Ltd PM-2009-03219-3-1 Extension of indications 15/06/11
Botox Botulinum toxin type A Allergan Australia Pty Ltd PM-2010-03508-3-3 Extension of indications 06/07/12
Brenzys Etanercept (rch) Samsung Bioepis AU Pty Ltd PM-2015-01528-1-3 New biological entity 21/06/17
Breo Ellipta Fluticasone furoate / vilanterol trifenatate GlaxoSmithKline Australia Pty Ltd PM-2012-01970-3-5 New chemical entity, New combination 25/06/14
Breo Ellipta Vilanterol trifenatate / fluticasone furoate GlaxoSmithKline Australia Pty Ltd PM-2012-01970-3-5 New chemical entity, New combination 25/06/14
Bretaris Genuair Aclidinium bromide A Menarini Australia Pty Ltd PM-2012-04170-1-5 New chemical entity 08/09/14
Brilinta Ticagrelor AstraZeneca Pty Ltd PM-2009-03523-3-3 New chemical entity 12/07/11
Brilinta Ticagrelor AstraZeneca Pty Ltd PM-2015-01532-1-3 New indication, New strength 31/05/17
Brinavess Vernakalant Merck Sharp & Dohme (Australia) Pty Ltd PM-2010-01025-3-3 New chemical entity 12/11/12
Brintellix Vortioxetine hydrobromide Lundbeck Australia Pty Ltd PM-2012-03463-1-1 New chemical entity 08/07/14
Briviact Brivaracetam UCB Australia Pty Ltd PM-2015-01568-1-1 New biological entity 07/03/17
Bronchitol Mannitol Pharmaxis Ltd PM-2009-03748-3-5 Extension of indications 29/03/11
Budenofalk Budesonide Orphan Australia Pty Ltd PM-2010-03268-3-1 Major variation (new dose form, new indications) 22/10/12
Byetta Exenatide Eli Lilly Australia Pty Ltd PM-2011-01931-3-5 Major variation (extension of indications) 03/06/13
Byetta / Bydureon Exenatide Eli Lilly Australia Pty Ltd PM-2010-02389-3-5 Extension of indications, New dosage form 05/02/13

C

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Cafnea Caffeine citrate Phebra Pty Ltd PM-2008-2175-5 New chemical entity 17/03/10
Caldolor Ibuprofen Phebra Pty Ltd PM-2010-02393-3-1 Major variation (new dosage form, new route of administration) 02/01/13
Caprelsa Vandetanib AstraZeneca Pty Ltd PM-2011-03002-3-4 New chemical entity 07/08/13
Carbaglu Carglumic acid Emerge Health Pty Ltd PM-2013-02751-1-3 New chemical entity 02/09/15
Cayston Aztreonam Gilead Sciences Pty Ltd PM-2007-3666-2 New dosage form 02/02/10
Celebrex Celecoxib Pfizer Australia Pty Ltd PM-2009-01564-3-1 Extension of indications 23/06/10
Celsentri Maraviroc ViiV Healthcare Pty Ltd PM-2010-02896-3-2 Major variation (extension of indications) 12/05/13
Cerdelga / Eliglustat Genzyme Eliglustat (as tartrate) Sanofi-Aventis Australia Pty Ltd PM-2013-03651-1-1 New chemical entity 05/08/15
Certican Everolimus Novartis Pharmaceuticals Australia Pty Limited PM-2011-03534-3-2 Extension of indications, New dosage recommendations, Changes to Product Information 21/05/13
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) 22/06/11
Cervarix Human papillomavirus vaccine types 16 and 18 (recombinant AS04 adjuvanted) GlaxoSmithKline Australia Pty Ltd PM-2014-01893-1-2 Major variation 04/01/16
Chemmart Sevelamer / Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / GenRx Sevelamer / Terry White Chemists Sevelamer Sevelamer hydrochloride Generic Partners PM-2013-00742-1-3 New generic 31/07/17
Cialis Tadalafil Eli Lilly Australia Pty Ltd PM-2011-03166-3-3 Extension of indications 22/07/13
Cimzia Certolizumab pegol UCB Australia Pty Ltd PM-2008-2508-3 New biological entity 22/12/09
Cimzia Certolizumab UCB Australia Pty Ltd PM-2013-00286-2-3 Extension of indications 15/08/14
Cimzia Certolizumab pegol (rbe) UCB Australia Pty Ltd PM-2013-04590-1-3 Major variation (extension of indications) 02/11/15
Cimzia Certolizumab pegol UCB Australia Pty Ltd PM-2015-01158-1-3 Extension of indications 21/06/17
Cinryze C1 esterase inhibitor Cedarglen Investments Pty Ltd PM-2010-03159-3-2 New chemical entity 29/07/13
Circadin Melatonin Commercial Eyes Pty Ltd PM-2008-2125-1 New chemical entity 28/11/09
Circadin Melatonin RAD Data Australia Pty Ltd PM-2010-01756-3-1 Extension of indications 18/01/11
Cleviprex Clevidipine Kendle Australia Pty Ltd PM-2008-3132-3 New chemical entity 12/04/10
Clobex Clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5 New chemical entity 22/05/13
Copegus / Pegasys RBV / Pegasys Peginterferon alfa-2a / Ribavirin Roche Australia Pty Ltd PM-2010-00382/00415/00416-3-2 Major variation 15/06/11
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 28/07/11
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 28/07/11
Coralan Ivabradine Servier Laboratories (Aust) Pty Ltd PM-2008-2832-3 Extension of indications 03/09/10
Coralan Ivabradine Servier Laboratories (Aust) Pty Ltd PM-2010-03269-3-3 Major variation (extension of indications) 31/10/12
Cortiment Budesonide Ferring Pharmaceuticals Pty Ltd PM-2014-04155-1-1 Major variation (new dosage form and new indication) 11/01/16
Cosentyx / Zafrez Secukinumab Novartis Pharmaceutical Australia Pty Ltd PM-2013-04153-1-4 New chemical entity 16/09/15
Cosentyx / Zafrez Secukinumab Novartis Pharmaceuticals Australia Pty Ltd PM-2015-00766-1-3 / 2015-00777-1-3 Extension of indications 25/10/16
Coveram Amlodipine (as besylate) / Perindopril arginine Servier Laboratories (Aust) Pty Ltd PM-2008-2262-3 New combination 13/11/09
Coveram Perindopril arginine / Amlodipine (as besylate) Servier Laboratories (Aust) Pty Ltd PM-2008-2262-3 New combination 13/11/09
Creon Micro Pancreatic extract Abbott Products Pty Ltd PM-2009-02729-3-1 New formulation 28/09/10
Crestor / Visacor Rosuvastatin AstraZeneca Pty Ltd PM-2009-01470-3-3 Extension of indications 25/05/11
Cyklokapron Tranexamic acid Pfizer Australia Pty Ltd PM-2009-00587 Extension of indications, New dosage form 10/09/10
Cymbalta Duloxetine Eli Lilly Australia Pty Ltd PM-2010-03270-3-1 Extension of indications 06/09/12

D

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Daivobet 50/500 Betamethasone / Calcipotriol (as dipropionate) LEO Pharma Pty Ltd PM-2011-04144-3-5 Extension of indications 09/08/13
Daivobet 50/500 Calcipotriol / Betamethasone (as dipropionate) LEO Pharma Pty Ltd PM-2011-04144-3-5 Extension of indications 09/08/13
Daklinza Daclatasvir dihydrochloride Bristol-Myers Squibb Australia Pty Ltd PM-2014-00647-1-2 New chemical entity 14/12/15
Dalveza / Daxas / Xevex Roflumilast Nycomed Pty Ltd PM-2009-02915-3-5 New chemical entity 20/12/11
Daxas / Xevex / Dalveza Roflumilast Nycomed Pty Ltd PM-2009-02915-3-5 New chemical entity 20/12/11
Decapeptyl Triptorelin acetate Ferring Pharmaceuticals Pty Ltd PM-2013-04578-1-5 New chemical entity 24/08/15
Descovy Emtricitabine / Tenofovir alafenamide (as fumarate) Gilead Sciences Pty Ltd PM-2015-01283-1-3 New fixed dose combination 20/12/16
Descovy Tenofovir alafenamide (as fumarate) / Emtricitabine Gilead Sciences Pty Ltd PM-2015-01283-1-3 New fixed dose combination 20/12/16
Dificid Fidaxomicin Specialised Therapeutics Australia Pty Ltd PM-2012-04269-3-2 New chemical entity 26/09/13
DigiFab Digoxin-specific antibody fragment F(Ab) (Ovine) Phebra Pty Ltd PM-2012-03387-1-3 New biological entity 05/05/14
Docetaxel-PF Docetaxel Pfizer Australia Pty Ltd PM-2011-01623-3-4 New generic 13/05/13
Dronedarone Winthrop / Dronedarone Sanofi / Multaq Dronedarone hydrochloride Sanofi-Aventis Australia Pty Ltd PM-2008-3045-3 New chemical entity 05/10/10
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 28/07/11
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 28/07/11
Duodart Dutasteride / Tamsulosin GlaxoSmithKline Australia Pty Ltd PM-2009-01559-3-3 New fixed dose combination 20/10/10
Duodart Tamsulosin / Dutasteride GlaxoSmithKline Australia Pty Ltd PM-2009-01559-3-3 New fixed dose combination 20/10/10
Dymista / Dylastine Azelastine hydrochloride / fluticasone propionate Meda Pharmaceuticals Pty Ltd PM-2012-03466-1-5 New combination of active ingredients 24/07/14
Dymista/Dylastine Fluticasone propionate / azelastine hydrochloride Meda Pharmaceuticals Pty Ltd PM-2012-03466-1-5 New combination of active ingredients 24/07/14

E

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
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 14/01/13
Edomlus / Lambeto /Toujeo Insulin glargine (rbe) Sanofi Aventis Australia Pty Ltd PM-2014-00670-1-5 New strength 06/01/17
Edurant Rilpivirine Janssen-Cilag Pty Ltd PM-2010-03030-3-2 New chemical entity 27/03/12
Ejocia HCT / Exforge HCT Amlodipine (as besylate) / Valsartan / Hydrochlorothiazide Novartis Pharmaceuticals Australia Pty Limited PM-2008-03499-3-3 New fixed combination 26/08/10
Elelyso Taliglucerase alfa rpc Pfizer Australia Pty Ltd PM-2013-00303-1-3 New biological entity 14/10/14
Eliglustat Genzyme / Cerdelga Eliglustat (as tartrate) Sanofi-Aventis Australia Pty Ltd PM-2013-03651-1-1 New chemical entity 05/08/15
Eliquis Apixaban Bristol-Myers Squibb Australia Pty Ltd PM-2010-01492-3-3 New chemical entity 20/09/11
Eliquis Apixaban Bristol-Myers Squibb Australia Pty Ltd PM-2011-03165-3-3 Extension of indications 21/06/13
Eliquis Apixaban Bristol-Myers Squibb Australia Pty Ltd PM-2014-00349-1-3 Extension of indications 11/11/15
EllaOne Ulipristal acetate ERA Consulting (Australia) Pty Ltd PM-2013-04154-1-5 New chemical entity 04/09/15
Eloctate Efmoroctocog alfa (rhu) Biogen Idec Australia Pty Ltd PM-2013-01157-1-4 New biological entity 17/03/15
Elonva Corifollitropin alfa Schering-Plough Pty Ltd PM-2009-00870-3-5 New chemical entity 21/07/10
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) 23/03/11
Eltroxin, Aspen Thyroxine, Thyroxine Aspen Thyroxine sodium Aspen Pharma Pty Ltd PM-2012-04477-1-5 New generic, New strength 12/06/14
Emend Aprepitant Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-00237-3-4 Major variation (new dosage regimen, new dosage) 12/11/12
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 14/01/13
Emtriva Emtricitabine Gilead Sciences Pty Ltd PM-2012-02513-3-2 Major variation (extension of indications) 12/06/14
Enbrel Etanercept Wyeth Australia Pty Ltd PM-2008-03723-3-4 Extension of indications 16/02/10
Enbrel Etanercept Pfizer Australia Pty Ltd PM-2010-03845-3-4 Extension of indications 19/03/12
Enbrel Etanercept (rch) Pfizer Australia Pty Ltd PM-2012-04135-1-3 Extension of indications 24/03/14
Enbrel Etanercept Pfizer Australia Pty Ltd PM-2013-04552-1-3 Extension of indications 23/09/15
Endometrin Pessaries Progesterone Ferring Pharmaceuticals Pty Ltd PM-2011-02023-3-5 Major variation (new strength) 12/06/13
Enidin P / Alphagan P Brimonidine tartrate Allergan Australia Pty Ltd PM-2008-03768-3-5 New strength, Change in formulation, New trade names 24/05/10
Entresto / Novartis sacubitril/valsartan Sacubitril / Valsartan salt complex Novartis Pharmaceuticals Australia Pty Ltd PM-2015-00001-1-3 New combination product 23/09/16
Entresto / Novartis sacubitril/valsartan Valsartan salt complex / Sacubitril Novartis Pharmaceuticals Australia Pty Ltd PM-2015-00001-1-3 New combination product 23/09/16
Entyvio / Kynteles Vedolizumab (rch) Takeda Pharmaceuticals Australia Pty Ltd PM-2013-01102-1-1 New biological entity 17/11/14
Enviage HCT / Rasilez HCT Aliskiren (as hemifumarate) / Hydrochlorothiazide Novartis Pharmaceuticals Australia Pty Limited PM-2008-2072-3 New fixed combination 12/03/10
Ephedrine Hydrochloride MYX Ephedrine Hydrochloride Mayne Pharma International Pty Ltd PM-2015-01131-1-3 Major variation (new strength) 22/06/17
Erbitux Cetuximab Merck Serono Australia Pty Ltd PM-2008-03405-3-4 Extension of indications 15/01/10
Erbitux Cetuximab Merck Serono Australia Pty Ltd PM-2009-02587-4 Extension of indications 19/10/11
Erbitux Cetuximab Merck Serono Australia Pty Ltd PM-2012-00340-3-4 Major variation (review of indications, changes to Product Information) 01/10/13
Erivedge Vismodegib Roche Products Pty Ltd PM-2012-00329-3-4 New chemical entity 13/09/13
Esbriet Pirfenidone Roche Products Pty Ltd PM-2015-00413-1-5 New chemical entity 09/08/16
Esmya Ulipristal acetate Vifor Pharma Pty Ltd PM-2015-00776-1-5 Extension of indications 19/10/16
Evicel Fibrin haemostatic agent/sealant Johnson & Johnson Medical Pty Ltd PM-2009-03561-3-4 New chemical entity 11/12/12
Eviplera Tenofovir disoproxil fumarate / emtricitabine / rilpivirine Gilead Sciences Pty Ltd PM-2010-02853-3-2 New chemical entity 27/03/12
Eviplera Emtricitabine / Tenofovir disoproxil fumarate / rilpivirine Gilead Sciences Pty Ltd PM-2010-02853-3-2 New chemical entity 27/03/12
Eviplera Rilpivirine / Tenofovir disoproxil fumarate / emtricitabine Gilead Sciences Pty Ltd PM-2010-02853-3-2 New chemical entity 27/03/12
Eviplera Tenofovir disoproxil fumarate / emtricitabine / rilpivirine Gilead Sciences Pty Ltd PM-2013-01524-1-2 Extension of indications 15/07/14
Eviplera Emtricitabine / rilpivirine / tenofovir disoproxil fumarate Gilead Sciences Pty Ltd PM-2013-01524-1-2 Extension of indications 15/07/14
Eviplera Rilpivirine / Tenofovir disoproxil fumarate / emtricitabine Gilead Sciences Pty Ltd PM-2013-01524-1-2 Extension of indications 15/07/14
Evogam Immunoglobulin - normal (human) CSL Limited PM-2010-01887-3-2 Major variations (new strength, new route of administration, change in manufacture and tradename) 07/05/12
Exforge HCT / Ejocia HCT Amlodipine (as besylate) / Valsartan / Hydrochlorothiazide Novartis Pharmaceuticals Australia Pty Limited PM-2008-03499-3-3 New fixed combination 26/08/10
Exforge HCT / Ejocia HCT Hydrochlorothiazide / Valsartan / Amlodipine (as besylate) Novartis Pharmaceuticals Australia Pty Limited PM-2008-03499-3-3 New fixed combination 26/08/10
Exforge HCT / Ejocia HCT Valsartan / Amlodipine (as besylate) / Hydrochlorothiazide Novartis Pharmaceuticals Australia Pty Limited PM-2008-03499-3-3 New fixed combination 26/08/10
Exforge/Ejocia 10/320; Exforge/Ejocia 5/320 Valsartan / Amlodipine Novartis Pharmaceuticals Australia Pty Limited PM-2009-01168-3-3 Major variation (new strength) 26/07/10
Exforge/Ejocia 5/320 / Exforge/Ejocia 10/320 Amlodipine / Valsartan Novartis Pharmaceuticals Australia Pty Limited PM-2009-01168-3-3 Major variation (new strength) 26/07/10
Exjade Deferasirox Novartis Pharmaceuticals Australia Pty Limited PM-2012-03063-1-4 Extension of indications 06/03/14
Eylea Aflibercept Bayer Australia Limited PM-2010-03802-3-5 New chemical entity 30/07/12
Eylea Aflibercept (rch) Bayer Australia Limited PM-2012-03146-3-5 Extension of indications, Changes to Product Information 04/08/14
Eylea Aflibercept Bayer Australia Ltd PM-2013-04198-1-1 Extension of indications 21/07/15
Ezalo Composite Pack / Rosuzet Composite Pack Ezetimibe and rosuvastatin (as calcium) Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-03419-1-3 New combination of active ingredients 05/03/14
Ezalo, Rosuzet Ezetimibe / Rosuvastatin (as calcium) Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-02434-1-3 New fixed dose combination 29/01/15
Ezalo, Rosuzet Rosuvastatin (as calcium) / Ezetimibe Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-02434-1-3 New fixed dose combination 29/01/15
Ezetrol Ezetimibe Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01220-3-3 Extension of indications 28/02/13
Ezetrol / Vytorin Ezetimibe and ezetimibe / simvastatin Merck Sharp & Dohme (Australia) Pty Limited PM-2015-01525-1-3 Extension of indications 26/06/17

F

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Fampyra Fampridine Biogen Idec Australia Pty Ltd PM-2010-00524-3-1 New chemical entity 15/06/11
Fanapt Iloperidone Kendle R & D Pty Ltd PM-2010-02772-3 New chemical entity 18/06/12
Fentora Fentanyl citrate Orphan Australia Pty Ltd PM-2013-03632-1-1 New dose form, New route of administration 22/04/15
Ferinject Ferric carboxymaltose Vifor Pharma Pty Ltd PM-2009-01623-3-4 New chemical entity 24/05/11
Ferriprox Deferiprone Orphan Australia Pty Ltd PM-2010-00539-3-4 Extension of indications, Increase in dosage, Changes to Product Information 04/10/11
Fetzima Levomilnacipran (as hydrochloride) Pierre Fabre Australia Pty Ltd PM-2014-04276-1-1 New chemical entity 13/12/16
Filosir / Fynefta / Gilenya Fingolimod Novartis Pharmaceuticals Australia Pty Limited PM-2010-00401-3-1 New chemical entity 29/03/11
Firazyr Icatibant Shire Australia Pty Ltd SM-2009-00755-3-2 New chemical entity 07/06/10
Firmagon Degarelix Ferring Pharmaceuticals Pty Ltd PM-2008-2254-4 New chemical entity 16/02/10
Flebogamma 10% DIF IVIg Grifols Australia Pty Ltd PM-2010-03276-3-2 Major variation (new strength) 03/09/13
Fluad Paediatric Trivalent seasonal influenza vaccine, inactivated / MF59C.1 adjuvanted Novartis Vaccines and Diagnostics Pty Ltd PM-2010-03905-3-2 New biological entity 04/10/12
Fluad Paediatric MF59C.1 adjuvanted / Trivalent seasonal influenza vaccine, inactivated Novartis Vaccines and Diagnostics Pty Ltd PM-2010-03905-3-2 New biological entity 04/10/12
Fluarix Tetra Influenza virus haemagglutinin inactivated split influenza vaccine GlaxoSmithKline Australia Pty Ltd PM-2012-02287-3-2 New chemical/biological entity 06/02/14
FluQuadri, FluQuadri Junior Influenza Virus Haemagglutinin H1N1, H3N2, B Victoria lineage, B Yamagata lineage Sanofi-Aventis Australia Pty Ltd PM-2013-02401-1-2 New biological entity 06/02/15
Flutiform Fluticasone propionate / Eformoterol fumarate dihydrate Mundipharma Pty Ltd PM-2010-03251-3-5 New combination of active ingredients 13/06/13
Flutiform Eformoterol fumarate dihydrate / Fluticasone propionate Mundipharma Pty Ltd PM-2010-03251-3-5 New combination of active ingredients 13/06/13
Folotyn Pralatrexate Mundipharma Pty Ltd PM-2011-03153-3-4 New chemical entity 22/08/13
Forteo Teriparatide Eli Lilly Australia Pty Ltd PM-2009-02138-3-5 Major variation (extension of treatment duration) 07/09/10
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 14/01/13
Fosrenol Lanthanum carbonate Shire Australia Pty Ltd PM-2010-01654-3-3 Extension of indications 14/02/12
Fragmin Dalteparin Pfizer Australia Pty Ltd PM-2009-00586-3-3 Extension of indications 27/05/10
Frisium Clobazam Sanofi-Aventis Australia Pty Ltd PM-2011-04302-3-1 Extension of indications 03/10/13
Fycompa Perampanel (as hemisesquihydrate) Eisai Australia Pty Ltd/Commercial Eyes Pty Ltd PM-2013-00324-1-1 New chemical entity 14/10/14
Fynefta / Filosir / Gilenya Fingolimod Novartis Pharmaceuticals Australia Pty Limited PM-2010-00401-3-1 New chemical entity 29/03/11

G

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Gadovist Gadobutrol Bayer Australia Ltd PM-2013-04968-1-2 Extension of indications 01/06/15
Gadovist 1.0 Gadobutrol Bayer Australia Ltd PM-2015-01572-1-2 Major variation 31/01/17
Galvumet / Sobrea Metformin hydrochloride / Vildagliptin Novartis Pharmaceuticals Australia Pty Limited PM-2009-00972-3-5 New fixed combination 07/12/10
Galvumet / Sobrea Vildagliptin / Metformin hydrochloride Novartis Pharmaceuticals Australia Pty Limited PM-2009-00972-3-5 New fixed combination 07/12/10
Galvus / Xiliarx Vildagliptin Novartis Pharmaceuticals Australia Pty Limited PM-2009-00158-3-5 New chemical entity 23/02/10
Gamunex Immunoglobulin - normal (human) Talecris Biotherapeutics Pty Ltd PM-2010-01870-3 -201870-3-2 Extension of indications, New route of administration 13/12/11
Gardasil Human papillomavirus quadrivalent vaccine Merck Sharp & Dohme (Australia) Pty Ltd PM-2009-00914-2 Extension of indications 08/10/10
Gardasil Human papillomavirus (Types 6, 11, 16 & 18) quadrivalent recombinant vaccine Merck Sharp & Dohme (Australia) Pty Ltd PM-2010-03191-3-2 Extension of indications 07/05/12
Gardasil 9 Human Papillomavirus 9 valent vaccine Merck Sharp & Dohme Australia Pty Ltd PM-2014-01099-1 New biological entity 03/01/17
Gazyva Obinutuzumab Roche Products Pty Ltd PM-2013-01148-1-4 New biological entity 26/08/14
Genotropin Somatropin Pfizer Australia Pty Ltd PM-2008-2730-5 Product information change 09/03/10
GenRx Sevelamer / Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / Terry White Chemists Sevelame Sevelamer hydrochloride Generic Partners PM-2013-00742-1-3 New generic 31/07/17
Genvoya Elvitegravir / Cobicistat / Emtricitabine / Tenofovir alafenamide (as fumarate) Gilead Sciences Pty Ltd PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Genvoya Cobicistat / Emtricitabine / Tenofovir alafenamide (as fumarate) / Elvitegravir Gilead Sciences Pty Ltd PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Genvoya Emtricitabine / Tenofovir alafenamide (as fumarate) / Elvitegravir / Cobicistat Gilead Sciences Pty Ltd PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Genvoya Tenofovir alafenamide (as fumarate) / Elvitegravir / Cobicistat / Emtricitabine Gilead Sciences Pty Ltd PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Gilenya / Fynefta/ Filosir Fingolimod Novartis Pharmaceuticals Australia Pty Limited PM-2010-00401-3-1 New chemical entity 29/03/11
Giotrif Afatinib (as dimaleate) Boehringer Ingelheim Pty Limited PM-2012-02708-3-4 New chemical entity 14/04/14
Gliclazide Gppl MR 30 Gliclazide Generic Partners Pty Ltd PM-2015-00426-1-5 New generic medicine 19/07/16
Gliolan Aminolevulinic acid HCl Specialised Therapeutics Australia Pty Ltd PM-2012-03095-1-2 New chemical entity 03/03/14
Glivec Imatinib (as mesylate) Novartis Pharmaceuticals Australia Pty Limited PM-2011-02797-3-4 Major variation (extension of duration of treatment) 04/06/13
Glivec Imatinib Novartis Pharmaceuticals Australia Pty Limited PM-2012-02722-3-4 Extension of indications 22/01/14
Glypressin Terlipressin acetate Ferring Pharmaceuticals Pty Ltd PM-2010-03182-3-3 New chemical entity 26/11/12
GyMiso Misoprostol MS Health PM-2011-01625-3-5 Extension of indications 02/10/12

H

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Halaven Eribulin mesilate Eisai Australia Pty Ltd PM-2011-01624-3-4 New chemical entity 17/05/13
Harvoni Ledipasvir / Sofosbuvir Gilead Sciences Pty Ltd PM-2014-00469-1-2 New chemical entity 08/10/15
Harvoni Sofosbuvir / Ledipasvir Gilead Sciences Pty Ltd PM-2014-00469-1-2 New chemical entity 08/10/15
Hemangiol Propranolol hydrochloride sponsor Pierre Fabre Medicament Australia Pty Ltd PM-2013-01250-1-4 Major variation (extension of indications new dose form and strength) 19/08/15
Hepsera Adefovir dipivoxil Gilead Sciences Pty Ltd PM-2009-00296-3-2 Extension of indications 29/04/10
Herceptin Trastuzumab Roche Products Pty Ltd PM-2009-03121 Major variation (extension of indications) 17/09/10
Herceptin Trastuzumab Roche Products Pty Ltd 2011-01528-3-4 Extension of indications 17/12/12
Herceptin Trastuzumab Roche Products Pty Ltd PM-2013-04600-1-4 New route of administration 03/08/15
Hexaxim Diphtheria toxoid / Haemophilus type B polysaccharide / hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Hexaxim Haemophilus type B polysaccharide / hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Hexaxim Hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Hexaxim Pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide / Hepatitis B surface antigen Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Hexaxim Poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide / Hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Hexaxim Tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide / Hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Hizentra Normal human immunoglobulin CSL Behring Ltd PM-2013-00301-2-2 New biological entity 25/06/14
Humatrope Somatropin Eli Lilly Australia Pty Ltd PM-2010-00615-3-5 Extension of indications 15/01/13
Humira Adalimumab (rch) AbbVie Pty Ltd PM-2012-01954-3-1 Extension of indications 25/10/13
Humira Adalimumab Abbott Australasia Pty Ltd (AbbVie Pty Ltd) PM-2012-02255-3-3 Extension of indications 22/01/14
Humira Adalimumab AbbVie Pty Ltd PM-2013-01154-1-1 Extension of indications, New strength 05/08/14
Humira Adalimumab (rch) AbbVie Pty Ltd PM-2014-01048-1-3 Extension of indications 10/12/15
Humira Adalimumab (rch) AbbVie Pty Ltd PM–2014-04326-1-4 Major variation; extension of indications 12/07/16
Humira Adalimumab AbbVie Pty Ltd PM-2015-01149-1-3 Extension of indications 20/03/17

I

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Iclusig Ponatinib ARIAD Pharmaceuticals Australia Pty Ltd PM-2013-02061-1-4 New chemical entity 16/04/15
Idelvion Albutrepenonacog alfa (rch) CSL Behring (Australia) Pty Ltd PM-2015-01850-1-4 New biological entity 26/09/17
Ilaris Canakinumab Novartis Pharmaceuticals Australia Pty Ltd PM-2013-01501-1-3 Extension of indications 25/11/14
Ilevro Nepafenac Alcon Laboratories (Australia) Pty Ltd PM-2014-00379-1-2 New chemical entity 23/12/15
Imbruvica Ibrutinib Janssen-Cilag Pty Ltd PM-2014-02780-1-4 New chemical entity 02/02/16
Imlygic Talimogene laherparepvec Amgen Australia Pty Ltd PM-2014-03464-1-4 New biological entity 31/05/16
Imojev Japanese Encephalitis Chimeric Virus Sanofi Pasteur Pty Ltd PM-2009-01554-3-2 New chemical entity 16/08/10
Imojev Japanese Encephalitis Vaccine (live, attenuated) Sanofi-Aventis Australia Pty Ltd PM-2012-02264-3-2 Major variation 03/02/14
Incivo Telaprevir Janssen-Cilag Pty Ltd PM-2010-03576-3-2 New chemical entity 26/10/12
Incruse Ellipta Umeclidinium bromide GlaxoSmithKline Australia Pty Ltd PM-2013-01505-1-5 New chemical entity 09/07/15
Indocid PDA Indomethacin Invida Australia Pty Ltd PM-2009-03539-3-3 Major variation (change in dosage and patient population) 18/03/11
Inlyta Axitinib Pfizer Australia Pty Ltd PM-2011-00876-3-4 New chemical entity 12/02/13
INOmax Nitric oxide Ikaria Australia Pty Ltd PM-2014-01399-1-3 Major variation (new indication) 15/05/17
Inspra Eplerenone Pfizer Australia Pty Ltd PM-2011-04066-3-3 Extension of indications 01/10/13
Instanyl Fentanyl citrate Takeda Pharmaceuticals Australia Pty Ltd PM-2012-00804-3-1 Major variation (new dose form) 11/11/13
Intragam 10 NF Immunoglobulin - normal (human) CSL Bioplasma Ltd PM-2009-01544-3-2 Extension of indications, New dosage 18/10/11
Intratect Immunoglobulin - normal (human) Link Medical Products Pty Ltd PM-2009-02495-3-2 New chemical entity 03/02/11
Invega Paliperidone Janssen-Cilag Pty Ltd PM-2009-00515-3-1 Extension of indications 14/12/09
Invega Paliperidone Janssen-Cilag Pty Ltd PM-2011-02378-3-1 Extension of indications 20/05/13
Invega Sustenna Paliperidone palmitate Janssen-Cilag Pty Ltd PM-2009-00926-3-1 New salt of a previously approved active ingredient 20/07/10
Invokana / Prominad Canagliflozin (as hemihydrate) Janssen-Cilag Pty Ltd PM-2012-02210-3-5 New chemical entity 03/03/14
Iressa Gefitinib AstraZeneca Pty Ltd PM-2009-02058-3-4 Extension of indications 29/06/10
Isentress Raltegravir Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-03107-3-2 New dosage form 03/06/13
Istodax Romidepsin Celgene Australia Pty Ltd PM-2012-01446-3-4 New chemical entity 20/11/13

J

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Jakavi Ruxolitinib Novartis Australia Pty Ltd PM-2012-01504-3-4 New chemical entity 21/01/14
Janssen Simeprevir / Olysio Simeprevir (as sodium) Janssen-Cilag Pty Ltd PM-2013-01557-1-2 New chemical entity 27/10/14
Janumet Sitagliptin / Metformin Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01226-3-5 Extension of indications 14/01/13
Janumet Metformin / Sitagliptin Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01226-3-5 Extension of indications 14/01/13
Januvia Sitagliptin (as phosphate monohydrate) MSD (Australia) Pty Limited PM 2011-01224-3-5 Extension of indications 20/12/12
Jardiance Empagliflozin Boehringer Ingelheim Pty Ltd PM-2013-00674-1-5 New chemical entity 27/01/15
Javlor Vinflunine ditartrate Pierre Fabre Medicament Australia Pty Ltd PM-2009-03102-3-4 New chemical entity 07/02/11
Jaydess Levonorgestrel Bayer Australia Limited PM-2012-01933-3-5 Major variation (new strength, new indication, modified deliver system) 05/02/14
Jetrea Ocriplasmin Alcon Laboratories Australia Pty Ltd PM-2012-04123-1-5 New biological entity 10/11/14
Jevtana Cabazitaxel Sanofi-Aventis Australia Pty Ltd PM-2010-02565-3-4 New chemical entity 09/02/12
Joncia Milnacipran hydrochloride Pierre Fabre Medicament Australia Pty Ltd PM-2011-02708-3-1 New chemical entity 24/01/12
Juvicor / Xelezor / Tesozor Sitagliptin / Simvastatin Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-02796-3-5 New fixed combination 06/06/13

K

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Kadcyla Trastuzumab emtansine Roche Products Pty Ltd PM-2012-02734-3-4 New chemical entity 17/03/14
Kalydeco Ivacaftor Vertex Pharmaceuticals Australia Pty Ltd PM-2012-01491-3-5 New chemical entity 29/11/13
Kalydeco Ivacaftor Vertex Pharmaceuticals Australia PM-2015-00399-1-5 Extension of indications 05/01/17
Keytruda Pembrolizumab (rch) Merck Sharp & Dohme (Australia) Pty Ltd PM-2014-01928-1-4 New biological chemical entity 14/10/16
Kineret Anakinra A Menarini Australia Pty Ltd PM-2013-04579-1-3 Major variation (extension of indications) 30/10/15
Kliovance Low Norethisterone acetate / Oestradiol Novo Nordisk Pharmaceuticals Pty Ltd PM-2010-00087-5-3 New strength 18/01/12
Kliovance Low Oestradiol / Norethisterone acetate Novo Nordisk Pharmaceuticals Pty Ltd PM-2010-00087-5-3 New strength 18/01/12
Kombiglyze Saxagliptin / Metformin hydrochloride Bristol-Myers Squibb Australia Pty Ltd PM-2012-00296-3-5 New fixed dose combination 15/10/13
Kombiglyze Metformin hydrochloride / Saxagliptin Bristol-Myers Squibb Australia Pty Ltd PM-2012-00296-3-5 New fixed dose combination 15/10/13
Kuvan Sapropterin dihydrochloride Merck Serono Australia Pty Ltd PM-2009-02891-3-3 New chemical entity 21/10/10
Kynteles / Entyvio Vedolizumab (rch) Takeda Pharmaceuticals Australia Pty Ltd PM-2013-01102-1-1 New biological entity 17/11/14

L

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Lambeto /Toujeo / Edomlus Insulin glargine (rbe) Sanofi Aventis Australia Pty Ltd PM-2014-00670-1-5 New strength 06/01/17
Latisse Bimatoprost Allergan Australia Pty Ltd PM-2012-02668-3-5 Extension of indications 18/07/14
Latuda Lurasidone hydrochloride Commercial Eyes Pty Ltd PM-2012-04452-1-1 New chemical entity 20/06/14
Lemtrada Alemtuzumab (rch) Sanofi-Aventis Australia Pty Ltd PM-2012-02297-3-1 New dosage strength, New patient group, New dosage regime 04/02/14
Lenvima Lenvatinib mesilate Eisai Australia Pty Ltd PM-2014-04321-1-4 New chemical entity 30/08/16
Levemir Insulin detemir (rys) Novo Nordisk Pharmaceuticals Pty Ltd PM-2012-02256-3-5 Major variation (change in patient group/pregnancy category) 28/03/14
Levitra Vardenafil Bayer Australia Limited PM-2009-02689-3-3 New dosage form, Change in dosage instructions 12/01/11
Lidaveg / Zaltrap / Aflitiv Aflibercept (rch) Sanofi-Aventis Australia Pty Ltd PM-2011-04301-3-4 New biological entity 29/07/13
Lipidil Fenofibrate Abbott Australasia Pty Ltd PM-2012-02387-3-5 Extension of indications 14/04/14
Livalo Pitavastatin Abbott Australasia Pty Ltd PM-2010-02898-3-3 New chemical entity 02/09/13
Lodotra Prednisone Mundipharma Pty Ltd PM 2011-00520-3-3 Major variation (new dosage form) 13/06/13
Lonquex Lipegfilgrastim (rbe) Teva Pharma Australia Pty Ltd PM- 2014-03142-1-4 New chemical entity 23/02/16
Lotemax Loteprednol etabonate Bausch & Lomb (Australia) Pty Ltd PM-2012-03141-1-5 New chemical entity 17/04/14
Lucassin Terlipressin Ikaria Australia Pty Ltd PM-2010-02975-3-1 New chemical entity 27/08/13
Lucentis Ranibizumab Novartis Pharmaceuticals Australia Pty Limited PM-2010-02527-3-5 Extension of indications 09/11/11
Lucentis Ranibizumab Novartis Pharmaceuticals Australia Pty Limited PM-2010-03258-3-5 Extension of indications, Changes to Product Information 01/12/11
Lucentis Ranibizumab Novartis Pharmaceuticals Australia Pty Ltd PM-2013-00985-1-5 Extension of indications 14/10/14
Lucrin Depot / Lucrin XL Depot Leuprorelin acetate Abbott Australasia Pty Ltd PM-2009-00544-3-4 New strength, New route of administration 30/07/10
Lyxumia / Lyxumia Treatment initiation pack / Lixisenatide Sanofi / Lixisenatide Sanofi Treatment initiation pack / Lixisenatide Winthrop / Lixisenatide Winthrop Treatment initiation packLyxumia / Lyxumia Treatment initiation pack / Lixisenatide Sanofi / Lixisenatide Sanofi Treatment initiation pack / Lixisenatide Winthrop / Lixisenatide Winthrop Treatment initiation pack Lixisenatide Sanofi-Aventis Australia Pty Ltd PM-2011-03163-3-5 New chemical entity 20/08/13

M

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
MabThera Rituximab Roche Products Pty Ltd PM-2009-00656-3-4 Extension of indications 19/02/10
MabThera Rituximab Roche Products Pty Ltd PM-2009-01744-3-3 Extension of indications, Broaden patient population 06/05/10
MabThera Rituximab Roche Products Pty Ltd PM-2010-01845-3-4 New dosage regimen 09/12/11
MabThera Rituximab Roche Products Pty Ltd PM-2012-00331-3-3 Extension of indications 13/08/13
MabThera Rituximab Roche Products Pty Ltd PM-2013-04906-1-3 New dosing schedule 27/08/15
MabThera Rituximab Roche Products Pty Ltd PM-2014-04709-1-4 Major variation 09/02/17
MabThera SC Rituximab Roche Products Pty Limited PM-2012-04453-1-4 New dose form 04/09/14
Mekinist Trametinib (as dimethyl sulfoxide) GlaxoSmithKline Australia Pty Ltd PM-2012-04134-1-4 New chemical entity 17/03/14
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 31/08/11
Menitorix Hib and group C Meningococcal conjugate vaccine GlaxoSmithKline Australia Pty Ltd PM-2009-00817-3-2 New biological entity (new combination vaccine) 02/08/10
Menitorix Meningococcal conjugate vaccine Group C and Hib GlaxoSmithKline Australia Pty Ltd PM-2009-00817-3-2 New biological entity (new combination vaccine) 02/08/10
Menopur Gonadotrophin - human menopausal Ferring Pharmaceuticals Pty Ltd PM-2009-01335-3-5 New chemical entity 12/10/11
Menveo Meningococcal conjugated vaccine Novartis Vaccines and Diagnostics Pty Ltd SM-2009-00001-3-2 New chemical entity 20/05/10
Micardis / Pritor Telmisartan Boehringer Ingelheim Pty Limited PM-2009-00165-3-3 Extension of indications 22/04/10
Mifepristone Linepharma Mifepristone MS Health PM-2010-02694-3-5 New chemical entity 02/10/12
Mirvaso Brimonidine (as tartrate) Galderma Australia Pty Ltd PM-2013-01459-1-5 New indication, New dosage form, New formulation, New strength 23/01/15
Misodel/ Misopess Misoprostol Ferring Pharmaceuticals Pty Ltd PM-2012-03740-1-5 Major variation (extension of indication, new dose form, new route of administration) 23/04/14
Movantik Naloxegol oxalate AstraZeneca Pty Ltd PM-2014-03892-1-1 New chemical entity 01/06/16
Movectro Cladribine Merck Serono Australia Pty Ltd PM-2009-02909-3-1 Extension of indications, New dose form, New route of administration 06/07/11
Mozobil Plerixafor Genzyme Australasia Pty Ltd SM-2008-03602-4 New chemical entity 23/07/10
MS-2 Step Mifepristone / misoprostol MS Health Pty Ltd PM-2013-01037-1-5 New combination of active ingredients 13/10/14
MS-2 Step Misoprostol / mifepristone MS Health Pty Ltd PM-2013-01037-1-5 New combination of active ingredients 13/10/14
Multaq / Dronedarone Winthrop / Dronedarone Sanofi Dronedarone hydrochloride Sanofi-Aventis Australia Pty Ltd PM-2008-3045-3 New chemical entity 05/10/10
Mycamine Micafungin (as sodium) Astellas Pharma Australia Pty Ltd PM-2011-04271-3-2 New chemical entity 09/08/13
Myfortic Mycophenolate sodium Novartis Pharmaceuticals Australia Pty Limited PM-2010-01235-3-2 Major variation (extension of indications) 17/05/13

N

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Naropin Ropivacaine AstraZeneca Pty Ltd PM-2009-01406-3-1 Extension of indications 23/04/10
Navelbine Vinorelbine Pierre Fabre Medicament Australia Pty Ltd PM-2010-03252-3-4 Extension of indications 30/05/12
Nesina / Vipidia Alogliptin (as benzoate) Takeda Pharmaceuticals Australia Pty Ltd PM-2012-01949-3-5 New chemical entity 09/01/14
Neupro Rotigotine UCB Australia Pty Ltd PM-2009-01999-3-1 Extension of indications, New strength 08/10/10
Nexavar Sorafenib Bayer Australia Ltd PM-2013-02057-1-4 Extension of indications, Changes to Product Information 06/08/14
Nimenrix Meningococcal (groups A,C,W-135,Y) polysaccharide tetanus toxoid conjugate vaccine GlaxoSmithKline Australia Pty Ltd PM-2012-01958-3-2 New chemical entity 04/12/13
Nivestim Filgrastim Hospira Pty Ltd PM-2009-00676-3-4 New chemical entity (biosimilar product) 13/09/10
NovoEight Turoctocog alfa (rch) Novo Nordisk Pharmaceuticals Pty Ltd PM-2012-03754-1-4 New chemical entity 07/05/14
NovoThirteen Catridecacog (rys) Novo Nordisk Pharmaceuticals Pty Ltd PM-2012-02713-3-4 New chemical (biological) entity 10/04/14
Nucala Mepolizumab (rch) GlaxoSmithKline Australia Pty Ltd PM-2014-03872-1-5 New biological entity 08/03/17
Nulojix Belatacept Bristol-Myers Squibb Australia Pty Ltd PM-2010-03075-3-2 New chemical entity 30/07/12
Nuvigil Armodafinil Teva Pharmaceuticals Australia Pty Ltd PM-2014-01922-1-1 New chemical entity 26/05/16
Nuwiq Simoctocog alfa rhu Octapharma Australia Pty Ltd PM-2013-02226-1-4 New biological entity 07/06/16

O

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Ofev / Vargatef Nintedanib esilate Boehringer Ingelheim Pty Ltd PM-2014-01847-1-4 New chemical entity 08/02/16
Olimel N5-860E, Olimel N7-960, Olimel N7-960E, Olimel N9-840,Olimel N9-840E, PeriOlimel N4-600E Electrolytes (with and without), Glucose, Lipids and Amino acids Baxter Healthcare Pty Ltd PM-2012-00805-3-1 New fixed combination 02/10/13
Olimel N5-860E, Olimel N7-960, Olimel N7-960E, Olimel N9-840,Olimel N9-840E, PeriOlimel N4-600E Glucose, Lipids and Amino acids, with and without Electrolytes Baxter Healthcare Pty Ltd PM-2012-00805-3-1 New fixed combination 02/10/13
Olimel N5-860E, Olimel N7-960, Olimel N7-960E, Olimel N9-840,Olimel N9-840E, PeriOlimel N4-600E Lipids, Amino acids and Glucose, with and without Electrolytes Baxter Healthcare Pty Ltd PM-2012-00805-3-1 New fixed combination 02/10/13
Olmetec Olmesartan medoxomil Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01941-3-3 Major variation (new dosage form, increase in patient group) 26/02/13
Olysio / Janssen Simeprevir Simeprevir (as sodium) Janssen-Cilag Pty Ltd PM-2013-01557-1-2 New chemical entity 27/10/14
Omacor Omega-3-acid ethyl esters 90 Abbott Products Pty Ltd PM-2008-3043-3 New chemical entity 28/07/10
Omnaris Ciclesonide Nycomed Pty Ltd PM-2009-03337-3-5 Extension of indications, New dose form, New route of administration 18/01/12
Onbrez Breezhaler / Arbeela Breezhaler Indacaterol Novartis Pharmaceuticals Australia Pty Limited PM-2009-00350-3-5 New chemical entity 27/10/10
Onglyza Saxagliptin Bristol-Myers Squibb / AstraZeneca PM-2010-03800-3-5 Major variation (new strength, new patient group, change in dosage) 25/06/12
Onglyza Saxagliptin (as hydrochloride) Bristol-Myers Squibb Australia Pty Ltd PM-2011-01174-3-5 Extension of indications 13/03/13
Onglyza Saxagliptin hydrochloride Bristol-Myers Squibb Australia Pty Ltd PM-2008-03469-3-5 New chemical entity 13/04/11
Onivyde Irinotecan (as sucrosofate) Baxalta Australia Pty Ltd PM-2015-03196-1-4 New chemical entity 05/10/17
Opdivo Nivolumab Bristol-Myers Squibb Australia Pty Ltd PM-2014-03852-1-4 New chemical entity 23/08/16
Opsumit Macitentan Actelion Pharmaceuticals Australia Pty Ltd PM-2012-04112-1-3 New chemical entity 28/04/14
Optaflu Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B) Novartis Vaccines & Diagnostics Pty Ltd PM-2013-04969-1-2 New chemical entity 24/08/15
Oracea Doxycycline monohydrate Galderma Australia Pty Ltd PM-2010-03584-3-4 Extension of indications, New presentation 06/06/13
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 15/06/11
Orencia Abatacept (rch) Bristol-Myers Squibb Australia Pty Ltd PM-2010-03115-3-3 Major variation (new dosage form, new route of administration) 26/04/12
Orencia Abatacept (rch) Bristol-Myers Squibb Australia Pty Ltd PM-2008-03683-3-3 Extension of indications 04/03/10
Orencia Abatacept (rch) Bristol-Myers Squibb Australia Pty Ltd PM-2010-00413-3-3 Extension of indications 15/06/11
Orfadin Nitisinone Orphan Australia Pty Ltd PM-2009-02266-3-3 New chemical entity 15/10/10
Orkambi 200/125 Ivacaftor / Lumacaftor Vertex Pharmaceuticals Australia Pty Ltd PM-2015-00424-1-5 New chemical entity in a fixed dose combination 08/09/16
Orkambi 200/125 Lumacaftor / ivacaftor Vertex Pharmaceuticals Australia Pty Ltd PM-2015-00424-1-5 New chemical entity in a fixed dose combination 08/09/16
Osteovan / Aclasta Zoledronic acid Novartis Australia Pty Ltd PM-2010-01920-3-5 Major variation 31/08/11
Otezla Apremilast Celgene Pty Ltd PM-2013-04920-1-3 New chemical entity 22/10/15
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) 23/03/11
Ozurdex Dexamethasone Allergan Australia Pty Ltd PM-2009-00795-3-5 Extension of indications, New dose form, New route of administration 19/10/11
Ozurdex Dexamethasone Allergan Australia Pty Ltd PM-2014-00332-1-5 Extension of indications 25/10/16

P

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Palexia IR Tapentadol CSL Limited PM-2009-02488-3-1 New chemical entity 17/11/10
Palexia SR Tapentadol CSL Limited PM-2009-02489-3-1 New chemical entity 28/02/11
Pandemic H1N1 influenza vaccine Pandemrix GlaxoSmithKline Australia Pty Ltd PM-2009-03526-3-2 Major variation 20/10/10
Pandemic Influenza Vaccine H5N1 Baxter Pandemic influenza vaccine Baxter Healthcare Pty Ltd PM-2008-1961-2 New biological entity 09/12/10
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, dosing schedule) 12/02/13
PecFent Fentanyl (as citrate) ERA Consulting (Australia) Pty Ltd PM-2011-00911-3-1 Major variation (new dosage form) 19/03/13
Pecfent Fentanyl (as citrate) AstraZeneca Pty Ltd PM-2013-01123-1-1 Major variation 20/05/14
Pegasys RBV / Pegasys / Copegus Peginterferon alfa-2a / Ribavirin Roche Australia Pty Ltd PM-2010-00382/00415/00416-3-2 Major variation 15/06/11
Pegasys RBV / Pegasys / Copegus Ribavirin / Peginterferon alfa-2a Roche Australia Pty Ltd PM-2010-00382/00415/00416-3-2 Major variation 15/06/11
Pergoveris Follitropin alfa (rch) / Lutropin alfa (rch) Merck Serono Australia Pty Ltd PM-2008-1439-5 New fixed combination 11/01/10
Pergoveris Lutropin alfa (rch) / Follitropin alfa (rch) Merck Serono Australia Pty Ltd PM-2008-1439-5 New fixed combination 11/01/10
PeriOlimel N4-600E, Olimel N5-860E, Olimel N7-960, Olimel N7-960E, Olimel N9-840,Olimel N9-840E Amino acids, Lipids and Glucose, with and without Electrolytes Baxter Healthcare Pty Ltd PM-2012-00805-3-1 New fixed combination 02/10/13
Perjeta Pertuzumab (rch) Roche Products Pty Ltd PM-2012-00311-3-4 New biological entity 01/10/13
Perjeta Pertuzumab Roche Products Pty Limited PM-2014-04259-1-4 Extension of indications 16/06/16
Pharmacor Alendronate / Alendraccord / Alendrocor Alendronic acid Accord Healthcare Pty Ltd PM-2009-01135-3-5 New generic 16/02/11
Phenasen Arsenic trioxide Phebra Pty Ltd PM-2014-02385-1-4 Extension of indications 16/12/15
Phosligand / Sevelamer GPPL / Sevelamer GxP / Seveligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / GenRx Sevelamer / Terry White Chemists Sevelame Sevelamer hydrochloride Generic Partners PM-2013-00742-1-3 New generic 31/07/17
Picato 0.015% and 0.05% gel Ingenol mebutate LEO Pharma Pty Ltd PM-2011-02307-3-5 New chemical entity 06/06/13
Plegridy Peginterferon beta 1a (rch) Biogen Idec Australia Pty Ltd PM-2013-02425-1-1 Biological medicine 05/02/15
Pomalyst Pomalidomide Celgene Australia Pty Ltd PM-2013-02037-1-4 New chemical entity 13/10/14
Pradaxa Dabigatran etexilate mesilate Boehringer Ingelheim Pty Limited PM-2010-00120-3-3 Extension of indications, New strength, Changes to currently approved strengths 24/05/11
Pradaxa Dabigatran etexilate Boehringer Ingelheim Pty Ltd PM-2013-02038-1-3 Major variation (extension of indications) 04/01/16
Praluent (Golyra/Eliriduc) Alirocumab (rch) Sanofi-Aventis Australia Pty Ltd PM-2015-00764-1-3 New biological entity 13/12/16
Praxbind Idarucizumab Boehringer Ingelheim Pty Ltd PM-2015-00707-1-3 New biological medicine 25/10/16
Preflucel Split virus / Vero cell derived / Inactivated influenza vaccine Baxter Healthcare Pty Ltd PM-2010-03274-3-2 New biological entity 06/07/12
Preflucel Inactivated influenza vaccine / Split virus / Vero cell derived Baxter Healthcare Pty Ltd PM-2010-03274-3-2 New biological entity 06/07/12
Preflucel Vero cell derived / Inactivated influenza vaccine / Split virus Baxter Healthcare Pty Ltd PM-2010-03274-3-2 New biological entity 06/07/12
Prepandemic H5N1 adjuvanted Influenza Vaccine / Aflunov Influenza Virus Haemagglutinin H5N1 Novartis Vaccines and Diagnostics Pty Ltd PM-2009-03929-3-2 New biosimilar medicine similar to other pandemic and seasonal influenza vaccines 06/07/11
Prepandrix Purified antigen fractions of inactivated split virion A/Indonesia/05/2005 (H5N1) AS03 adjuvanted GlaxoSmithKline Australia Pty Ltd PM‐2013‐04610‐1‐2 New biological entity 23/12/15
Prevenar 13 Pneumococcal Polysaccharide Conjugate Vaccine Wyeth Australia Pty Ltd PM-2009-00110-3-2 New biological entity 13/05/10
Prevenar 13 Pneumococcal Polysaccharide Conjugate Vaccine 13 valent Pfizer Australia Pty Ltd PM-2010-03262-3-2 Extension of indications, Changes to Product Information 13/12/11
Prevenar 13 Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed Pfizer Australia Pty Ltd PM-2012-02211-3-2 Extension of indications, Changes to Product Information 07/02/14
Prevenar 13 Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed Pfizer Australia Pty Ltd PM-2013-01480-1-3 Extension of indications 17/09/14
Priligy Dapoxetine Janssen-Cilag Pty Ltd PM-2007-3614-3 New chemical entity 23/11/10
Pritor / Micardis Telmisartan Boehringer Ingelheim Pty Limited PM-2009-00165-3-3 Extension of indications 22/04/10
Prochymal Remestemcel-L ex vivo adult human mesenchymal stem cells Delpharm Consultants Pty Limited PM-2011-01529-3-2 New biological entity 05/03/15
Prograf-XL Tacrolimus Janssen-Cilag Pty Ltd PM-2008-03783-3-2 New dosage form 06/05/10
Prolia Denosumab Amgen Australia Pty Ltd PM-2009-00390-3-5 New biological entity 26/10/10
Prolia Denosumab Amgen Australia Pty Ltd PM-2012-02302-3-5 Extension of indications 28/01/14
Prometrium / Utrogestan Progesterone Besins Healthcare Australia Pty Ltd PM-2014-03908-1-5 Extension of indications 01/06/17
Prominad / Invokana Canagliflozin (as hemihydrate) Janssen-Cilag Pty Ltd PM-2012-02210-3-5 New chemical entity 03/03/14
Proshaeos Alprostadil Commercial Eyes Pty Ltd PM-2014-03512-1-3 Major variation 09/06/16
Protos Strontium ranelate Servier Laboratories (Aust) Pty Ltd PM-2011-00498-3-5 Extension of indications 07/01/13

Q

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Qlaira Dienogest / Oestradiol valerate Bayer Australia Limited PM-2009-02910-3-5 Extension of indications 28/03/11
Qlaira Oestradiol valerate / Dienogest Bayer Australia Limited PM-2009-02910-3-5 Extension of indications 28/03/11
Qtern Dapagliflozin / Saxagliptin AstraZeneca Pty Ltd PM-2015-02415-1-5 New fixed dose combination 06/10/17
Qtern Saxagliptin / Dapagliflozin AstraZeneca Pty Ltd PM-2015-02415-1-5 New fixed dose combination 06/10/17

R

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Rasilamlo Aliskiren / Amlodipine Novartis Pharmaceuticals Australia Pty Limited PM-2010-00719-3-3 New fixed combination 05/08/11
Rasilamlo Amlodipine / Aliskiren Novartis Pharmaceuticals Australia Pty Limited PM-2010-00719-3-3 New fixed combination 05/08/11
Rasilamlo HCT Aliskiren / Amlodipine / Hydrochlorothiazide Novartis Pharmaceuticals Australia Pty Limited PM-2010-02677-3-3 New combination of active ingredients 15/06/12
Rasilamlo HCT Amlodipine / Aliskiren / Hydrochlorothiazide Novartis Pharmaceuticals Australia Pty Limited PM-2010-02677-3-3 New combination of active ingredients 15/06/12
Rasilamlo HCT Hydrochlorothiazide / Aliskiren / Amlodipine Novartis Pharmaceuticals Australia Pty Limited PM-2010-02677-3-3 New combination of active ingredients 15/06/12
Rasilez HCT / Enviage HCT Aliskiren (as hemifumarate) / Hydrochlorothiazide Novartis Pharmaceuticals Australia Pty Limited PM-2008-2072-3 New fixed combination 12/03/10
Rasilez HCT / Enviage HCT Hydrochlorothiazide / Aliskiren (as hemifumarate) Novartis Pharmaceuticals Australia Pty Limited PM-2008-2072-3 New fixed combination 12/03/10
Rebif Interferon beta-1a Merck Serono Australia Pty Ltd PM-2012-00320-3-1 Extension of indications 10/10/13
Remicade Infliximab Janssen-Cilag Pty Ltd PM-2011-00196-3-1 Extension of indications 17/12/12
Remniq Alemtuzumab (rch) Sanofi-Aventis Australia Pty Ltd PM-2012-02297-3-1 New dosage strength, New patient group, New dosage regime 04/02/14
Removab Catumaxomab Biotech Regulatory Solutions PM-2010-03132-3-4 New chemical entity 11/03/14
Renvela / Sevelamer Carbonate Winthrop / Sevelamer Carbonate Sanofi Sevelamer carbonate Sanofi-Aventis Australia Pty Ltd PM-2013-04961-1-3 New chemical entity 02/10/15
Repatha Evolocumab (rch) Amgen Australia Pty Ltd PM-2014-03144-1-3 New biological entity 03/05/16
Replagal Agalsidase alfa ghu Shire Australia Pty Ltd PM-2009-01140-3-3 New manufacturing process 18/06/10
Resotrans Prucalopride Janssen-Cilag Pty Ltd PM-2010-03060-3-1 New chemical entity 23/11/11
Restasis Cyclosporin Allergan Australia Pty Ltd PM-2009-03746-3-5 Extension of indications, New dosage form 22/11/11
Revatio Sildenafil Pfizer Australia Pty Ltd PM-2010-00912-3-3 Extension of indications, Major variation 12/10/11
Revatio Sildenafil Pfizer Australia Pty Ltd PM-2010-00820-3-3 Extension of indications 19/10/11
Revlimid Lenalidomide Celgene Pty Ltd PM-2014-02792-1-4 Extension of indications, New strength 05/02/16
Revolade Eltrombopag olamine GlaxoSmithKline Australia Pty Ltd SM- 2009-00082-3-4 New chemical entity 26/10/10
Revolade Eltrombopag olamine GlaxoSmithKline Australia Pty Ltd PM-2012-01934-3-2 Major variation (extension of indications) 03/12/13
Revolade Eltrombopag Novartis Pharmaceuticals Australia Pty Ltd PM-2014-04303-1-4 Extension of indications 30/03/16
Reyataz Atazanavir Bristol-Myers Squibb Australia Pty Ltd PM-2012-01034-3-2 Major variation (change in paediatric dosage regimen, PI updates) 21/10/13
RiaSTAP Human fibrinogen CSL Limited PM-2009-01838-3-4 New chemical entity 13/10/10
Ribomustin Bendamustine hydrochloride Janssen-Cilag Pty Ltd PM-2013-01517-1-4 New chemical entity 06/01/15
Risperdal Consta Risperidone Janssen-Cilag Pty Ltd PM-2008-03495-3-1 Extension of indications 18/06/10
Rixubis Nonacog gamma Baxter Healthcare Pty Ltd PM-2012-03758-1-4 New biological entity 14/04/14
Rosuzet Composite Pack / Ezalo Composite Pack Rosuvastatin (as calcium) and ezetimibe Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-03419-1-3 New combination of active ingredients 05/03/14
Rosuzet, Ezalo Ezetimibe / Rosuvastatin (as calcium) Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-02434-1-3 New fixed dose combination 29/01/15
Rosuzet, Ezalo Rosuvastatin (as calcium) / Ezetimibe Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-02434-1-3 New fixed dose combination 29/01/15
Rupafin Rupatadine iNova Pharmaceuticals (Australia) Pty Ltd PM-2009-03232-3-5 New chemical entity 18/05/11

S

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Saflutan Tafluprost Merck Sharp & Dohme (Australia) Pty Ltd PM-2009-3896-5 New chemical entity 03/05/12
Samsca Tolvaptan Orphan Australia Pty Ltd PM-2010-02939-3-5 New chemical entity 04/10/12
Sancuso Granisetron Invida Australia Pty Ltd PM-2009-02620-3-4 New route of administration, New dosage form 21/06/11
Sandostatin LAR Octreotide Novartis Pharmaceuticals Australia Pty Limited PM-2010-03092-3-4 Extension of indications 14/02/12
Saphris Asenapine Schering-Plough Pty Ltd PM-2009-03233-3-1 New chemical entity 07/03/11
Sativex Nabiximols Novartis Pharmaceuticals Australia Pty Limited PM-2011-00150-3-1 New chemical entity 27/09/13
Saxenda Liraglutide Novo Nordisk Pharmaceuticals Pty Ltd PM-2014-01472-1-5 Extension of indications 23/03/16
Sayana Medroxyprogesterone acetate Pfizer Australia Pty Ltd PM-2009-03498-3-5 Major variation (route of administration) 27/07/11
Seasonique Levonorgestrel / ethinyloestradiol Teva Pharma Australia Pty Ltd PM-2015-00767-1-5 Major variation (change in dosage amount and regimen) 09/12/16
Seebri Breezhaler / Tovanor Breezhaler Glycopyrronium (as bromide) Novartis Pharmaceuticals Australia Pty Limited PM-2011-02800-3-5 New chemical entity 10/07/13
Selincro Nalmefene (as hydrochloride dihydrate) Lundbeck Australia Pty Ltd PM-2013-02690-1-1 New chemical entity 09/08/16
Seroquel, Seroquel XR Quetiapine (as fumarate) AstraZeneca Pty Ltd PM-2008-03436-1 Extension of indications 13/04/10
Sevelamer Carbonate Winthrop / Sevelamer Carbonate Sanofi / Renvela Sevelamer carbonate Sanofi-Aventis Australia Pty Ltd PM-2013-04961-1-3 New chemical entity 02/10/15
Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / GenRx Sevelamer / Terry White Chemists Sevelamer Sevelamer hydrochloride Generic Partners PM-2013-00742-1-3 New generic 31/07/17
Sevikar Amlodipine besylate / Olmesartan medoxomil Schering-Plough Pty Ltd PM-2008-03320-3-3 New fixed dose combination 21/09/10
Sevikar Olmesartan medoxomil / Amlodipine besylate Schering-Plough Pty Ltd PM-2008-03320-3-3 New fixed dose combination 21/09/10
Sevikar HCT Amlodipine (as besilate) / Hydrochlorothiazide / Olmesartan medoxomil Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-01550-3-3 New fixed dose combination 18/11/13
Sevikar HCT Hydrochlorothiazide / Olmesartan medoxomil / Amlodipine (as besilate) Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-01550-3-3 New fixed dose combination 18/11/13
Sevikar HCT Olmesartan medoxomil / Amlodipine (as besilate) / Hydrochlorothiazide Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-01550-3-3 New fixed dose combination 18/11/13
Signifor Pasireotide (as diaspartate) Novartis Pharmaceuticals Australia Pty Limited PM-2014-02743-3-5 New chemical entity 27/03/14
Simponi Golimumab Schering-Plough Pty Ltd PM-2008-1811-3 New biological entity 14/12/09
Simponi Golimumab (rmc) Janssen Cilag Pty Ltd PM-2015-01879-1-3 Extension of indications 19/06/17
Simponi and Simponi Smartject Injector Golimumab (rmc) Janssen-Cilag Pty Ltd PM-2012-01202-3-3 Extension of indications, Changes to Product Information 16/08/13
Simponi, Simponi smartject injector Golimumab (rmc) Janssen-Cilag Pty Ltd PM-2013-00215-1-1 Major variation (extension of indications) 19/05/14
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 15/03/12
SmofKabiven / SmofKabiven Electrolyte Free Emulsion Aminoven 10% (with or without electrolytes) / SMOFlipid 20% / glucose 42% Fresenius Kabi Australia Pty Ltd PM-2010-02110-3-1 New fixed combination 15/03/12
SmofKabiven / SmofKabiven Electrolyte Free Emulsion Glucose 42% / SMOFlipid 20% / Aminoven 10% (with or without electrolytes) Fresenius Kabi Australia Pty Ltd PM-2010-02110-3-1 New fixed combination 15/03/12
SMOFlipid Fish oil / Olive oil / Soya oil / Medium chain triglycerides Fresenius Kabi Australia Pty Ltd PM-2008-03674-3-1 New combination 10/06/10
SMOFlipid Medium chain triglycerides / Olive oil / Fish oil / Soya oil Fresenius Kabi Australia Pty Ltd PM-2008-03674-3-1 New combination 10/06/10
SMOFlipid Olive oil / Fish oil / Soya oil / Medium chain triglycerides Fresenius Kabi Australia Pty Ltd PM-2008-03674-3-1 New combination 10/06/10
SMOFlipid Soya oil / Medium chain triglycerides / Olive oil / Fish oil Fresenius Kabi Australia Pty Ltd PM-2008-03674-3-1 New combination 10/06/10
Sobrea / Galvumet Vildagliptin / Metformin hydrochloride Novartis Pharmaceuticals Australia Pty Limited PM-2009-00972-3-5 New fixed combination 07/12/10
Soolantra / Vastreka Ivermectin Galderma Australia Pty Ltd PM-2014-01877-1-2 Major variation (new dose form, new indications) 09/12/15
Sovaldi Sofosbuvir Gilead Sciences Pty Ltd PM-2013-01283-1-2 New chemical entity 05/08/14
Spedra Avanafil A Menarini Australia Pty Ltd PM-2014-02782-1-3 New chemical entity 27/10/16
Spiriva Respimat / Favint Respimat Tiotropium bromide Boehringer Ingelheim Pty Limited PM-2014-00350-1-5 Extension of indications 25/11/16
Sprycel Dasatinib Bristol-Myers Squibb Australia Pty Ltd PM-2010-01583-3-4 Major variation (extension of indications) 11/07/11
Stelara Ustekinumab Janssen-Cilag Pty Ltd PM-2013-04148-1-3 Extension of indications 09/07/15
Stivarga Regorafenib Bayer Australia Limited PM-2012-02342-3-4 New chemical entity 07/02/14
Stivarga Regorafenib Bayer Australia Ltd PM-2013-04954-1-4 Extension of indications 19/11/15
Strensiq Asfotase alfa (rch) Alexion Pharmaceuticals Australia Pty Ltd PM-2014-03845-1-3 New chemical entity 01/07/16
Stribild Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir / Cobicistat Gilead Sciences Pty Ltd PM-2011-03533-3-2 New fixed dose combination 05/08/13
Stribild Cobicistat / Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir Gilead Sciences Pty Ltd PM-2011-03533-3-2 New fixed dose combination 05/08/13
Stribild Elvitegravir / Tenofovir disoproxil fumarate / Emtricitabine / Cobicistat Gilead Sciences Pty Ltd PM-2011-03533-3-2 New fixed dose combination 05/08/13
Stribild Emtricitabine / Tenofovir disoproxil fumarate/ Elvitegravir / Cobicistat Gilead Sciences Pty Ltd PM-2011-03533-3-2 New fixed dose combination 05/08/13
Stribild Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir / Cobicistat Gilead Sciences Pty Ltd PM-2014-01079-1-2 Extension of indications 01/06/17
Stribild Emtricitabine / Elvitegravir / Cobicistat / Tenofovir disoproxil fumarate Gilead Sciences Pty Ltd PM-2014-01079-1-2 Extension of indications 01/06/17
Stribild Elvitegravir / Cobicistat / Tenofovir disoproxil fumarate / Emtricitabine Gilead Sciences Pty Ltd PM-2014-01079-1-2 Extension of indications 01/06/17
Stribild Cobicistat / Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir Gilead Sciences Pty Ltd PM-2014-01079-1-2 Extension of indications 01/06/17
Striverdi Respimat Olodaterol (as hydrochloride) Boehringer Ingelheim Pty Limited PM-2012-01920-3-5 New chemical entity 27/03/14
Stromectol Ivermectin Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-01113-3-2 Extension of indications 30/10/13
Suboxone Sublingual Film Buprenorphine / Naloxone Reckitt Benckiser (Australia) Pty Ltd PM-2009-01902-3-1 New dose form 07/12/10
Suboxone Sublingual Film Naloxone / Buprenorphine Reckitt Benckiser (Australia) Pty Ltd PM-2009-01902-3-1 New dose form 07/12/10
Sunvepra Asunaprevir Bristol-Myers Squibb Australia Pty Ltd PM- 2014-00648-1-2 New chemical entity 14/12/15
Sutent Sunitinib Pfizer Australia Pty Ltd PM-2010-01205-4 Extension of indications, New dosage 29/06/11
Symbicort Rapihaler Budesonide / Eformoterol AstraZeneca Pty Ltd PM-2008-03789-3-5 New strengths, Extension of indications, New dosing range, Other quality changes 26/02/13
Symbicort Rapihaler Eformoterol / Budesonide AstraZeneca Pty Ltd PM-2008-03789-3-5 New strengths, Extension of indications, New dosing range, Other quality changes 26/02/13
Symbicort Turbuhaler 200/6, 400/12 / Symbicort Rapihaler 200/6 Budesonide / Eformoterol fumarate dihydrate AstraZeneca Pty Ltd PM-2008-1992-5 Extension of indications 20/10/10
Symbicort Turbuhaler 200/6, 400/12 / Symbicort Rapihaler 200/6 Eformoterol fumarate dihydrate / Budesonide AstraZeneca Pty Ltd PM-2008-1992-5 Extension of indications 20/10/10
Synflorix Pneumococcal polysaccharide conjugate vaccine, 10-valent adsorbed GlaxoSmithKline Australia Pty Ltd PM-2010-02793-3-2 Major variation (extension of indications) 22/10/12

T

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
TachoSil Human Fibrinogen / Human Thrombin Nycomed Pty Ltd PM-2010-02840-3-4 New fixed combination 31/08/12
TachoSil Human Thrombin / Human Fibrinogen Nycomed Pty Ltd PM-2010-02840-3-4 New fixed combination 31/08/12
Tadim Colistimethate sodium Phebra Pty Ltd PM-2009-02764-3-2 New dose form, New route of administration 13/01/11
Tafinlar Dabrafenib mesilate GlaxoSmithKline Australia Pty Ltd PM-2012-02231-3-4 New chemical entity 09/01/14
Taltz Ixekizumab Eli Lilly Australia Pty Ltd PM-2015-01878-1-4 New chemical entity 08/05/17
Tamiflu Oseltamivir phosphate Roche Products Pty Ltd PM-2010-00616-3-2 Major variation (extension of indications/new population) 27/07/11
Taptiqom 15/5 Tafluprost/Timolol Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-03652-1-5 New fixed dose combination 28/07/15
Taptiqom 15/5 Timolol/Tafluprost Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-03652-1-5 New fixed dose combination 28/07/15
Tarceva Erlotinib Roche Products Pty Ltd PM-2009-00835-3-4 Extension of indications 09/11/10
Tarceva Erlotinib Roche Products Pty Ltd PM-2011-01993-3-4 Extension of indications 07/01/13
Targin Naloxone hydrochloride / Oxycodone hydrochloride Mundipharma Pty Ltd PM-2008-2938-1 New fixed combination 04/05/10
Targin Oxycodone hydrochloride / Naloxone hydrochloride Mundipharma Pty Ltd PM-2008-2938-1 New fixed combination 04/05/10
Targin Oxycodone / Naloxone Mundipharma Pty Ltd PM-2015-1090-1-1 Extension of indications, Major variation 07/06/17
Targin Naloxone / Oxycodone Mundipharma Pty Ltd PM-2015-1090-1-1 Extension of indications, Major variation 07/06/17
Tasigna Nilotinib Novartis Pharmaceuticals Australia Pty Limited PM-2010-01053-3-4 Extension of indications, New strength 04/10/11
Tecfidera Dimethyl fumarate Biogen Idec Australia Pty Ltd PM-2012-00808-3-1 New chemical entity 22/10/13
Teriflunomide Sanofi / Aubagio / Teriflunomide Winthrop Teriflunomide Sanofi-Aventis Australia Pty Ltd PM-2011-02772-3-1 New chemical entity 21/05/13
Teriflunomide Winthrop / Aubagio / Teriflunomide Sanofi Teriflunomide Sanofi-Aventis Australia Pty Ltd PM-2011-02772-3-1 New chemical entity 21/05/13
Terry White Chemists Sevelame / Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / GenRx Sevelamer Sevelamer hydrochloride Generic Partners PM-2013-00742-1-3 New generic 31/07/17
Tesozor / Juvicor / Xelezor Sitagliptin / Simvastatin Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-02796-3-5 New fixed combination 06/06/13
Tevagrastim Filgrastim Aspen Pharmacare Australia Pty Ltd PM-2009-1996-3-4 Similar biological medicinal product 17/10/11
Thromboreductin Anagrelide hydrochloride Orphan Australia Pty Ltd PM-2009-03102-3-4 Orphan drug 07/05/12
Thyroxine Aspen, Aspen Thyroxine, Eltroxin Thyroxine sodium Aspen Pharma Pty Ltd PM-2012-04477-1-5 New generic, New strength 12/06/14
Tisseel VH/SD Fibrin sealant Baxter Healthcare Pty Ltd PM-2009-00290-3-4 Extension of indications 06/04/10
Tisseel VH/SD Fibrin sealant / adhesive / haemostatic agent Baxter Healthcare Pty Ltd PM-2010-03271-3-4 Extension of indications, Additional method of administration 03/05/12
Tivicay Dolutegravir (as sodium) ViiV Healthcare Pty Ltd PM-2012-04124-1-2 New chemical entity 19/05/14
TOBI Podhaler Tobramycin inhalation powder Novartis Pharmaceuticals Australia Pty Limited PM-2011-00135-3-2 New dosage form 26/10/12
Toujeo / Edomlus / Lambeto Insulin glargine (rbe) Sanofi Aventis Australia Pty Ltd PM-2014-00670-1-5 New strength 06/01/17
Tovanor Breezhaler/Seebri Breezhaler Glycopyrronium (as bromide) Novartis Pharmaceuticals Australia Pty Limited PM-2011-02800-3-5 New chemical entity 10/07/13
Tracleer Bosentan Actelion Pharmaceuticals Australia Pty Ltd PM-2010-02897-3-4 Major variation (extension of indications) 05/09/12
Trajenta Linagliptin Boehringer Ingleheim (Australia) Pty Ltd PM-2010-02400-3-5 New chemical entity 12/12/11
Trajenta Linagliptin Boehringer Ingelheim Pty Limited PM-2012-01168-3-5 Extension of indications 26/09/13
Trajentamet Linagliptin / Metformin HCl Boehringer Ingelheim Pty Limited PM-2011-03536-3-5 New fixed combination 26/09/13
Trajentamet Metformin HCl / Linagliptin Boehringer Ingelheim Pty Limited PM-2011-03536-3-5 New fixed combination 26/09/13
Transtec Buprenorphine Mundipharma Pty Ltd PM-2014-03891-1-1 Major variation (new indication, dose form and dose regimen) 13/12/16
TREXJECT Methotrexate Link Medical Products Pty Ltd PM-2014-01050-1-3 Major variation (new presentation, new route of administration) 07/06/17
TREXJECT IN Methotrexate Link Medical Products Pty Ltd PM-2014-01050-1-3 Major variation (new presentation, new route of administration) 07/06/17
Triumeq Dolutegravir sodium / Abacavir sulfate / Lamivudine ViiV Healthcare Pty Ltd PM-2013-04112-1-2 New fixed dose combination 19/05/15
Triumeq Abacavir sulfate / Lamivudine / Dolutegravir sodium ViiV Healthcare Pty Ltd PM-2013-04112-1-2 New fixed dose combination 19/05/15
Triumeq Lamivudine / Dolutegravir sodium / Abacavir sulfate ViiV Healthcare Pty Ltd PM-2013-04112-1-2 New fixed dose combination 19/05/15
Trobalt Retigabine GlaxoSmithKline Australia Pty Ltd PM-2011-04248-3-1 New chemical entity 17/10/13
Trulicity Dulaglutide rch Eli Lilly Australia Ptd Ltd PM-2013-03639-1-5 New chemical entity 27/07/15
Truvada Tenofovir disoproxil fumarate / Emtricitabine Gilead Sciences Pty Ltd PM-2015-00411-1-2 Extension of indications 10/11/16
Truvada Emtricitabine / Tenofovir disoproxil fumarate Gilead Sciences Pty Ltd PM-2015-00411-1-2 Extension of indications 10/11/16
Twynsta Amlodipine / Telmisartan Boehringer Ingelheim Pty Limited PM-2009-03138-3-3 New fixed dose combination 14/02/11
Twynsta Telmisartan / Amlodipine Boehringer Ingelheim Pty Limited PM-2009-03138-3-3 New fixed dose combination 14/02/11
Tybost Cobicistat Gilead Sciences Pty Ltd PM-2012-02160-3-2 New chemical entity 16/12/13
Tykerb Lapatinib GlaxoSmithKline Australia Pty Ltd PM-2009-01276-3-4 Extension of indications 17/06/10
Tykerb Lapatinib GlaxoSmithKline Australia Pty Ltd PM-2011-00908-3-4 Extension of indications 12/11/12

U

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Ultibro Breezhaler 110/50 Indacaterol maleate / Glycopyrronium bromide Novartis Pharmaceuticals Australia Pty Ltd PM-2012-04395-1-5 New combination of active ingredients 23/10/14
Ultibro Breezhaler 110/50 Glycopyrronium bromide / Indacaterol maleate Novartis Pharmaceuticals Australia Pty Ltd PM-2012-04395-1-5 New combination of active ingredients 23/10/14
Ultiva Remifentanil (as hydrochloride) GlaxoSmithKline Australia Pty Ltd PM-2011-00909-3-1 Major variation (new mode of administration) 29/01/13
Uptravi Selexipag Actelion Pharmaceuticals Pty Ltd PM-2014-04586-1-3 New chemical entity 08/11/16
Urso / Ursofalk Ursodeoxycholic acid Orphan Australia Pty Ltd PM-2008-03582-3-1 Extension of indications, Change of dosage 28/07/10
Utrogestan / Prometrium Progesterone Besins Healthcare Australia Pty Ltd PM-2014-03908-1-5 Extension of indications 01/06/17

V

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Valcyte Valganciclovir Roche Products Pty Ltd PM-2014-01870-1-2 Major variation (dosage) 05/01/16
Valdoxan Agomelatine Servier Laboratories (Aust) Pty Ltd PM-2009-00483-3-1 New chemical entity 21/10/10
Valoid Cyclizine lactate Link Medical Products Pty Ltd PM-2010-03573-3-1 New chemical entity 15/01/13
Vargatef / Ofev Nintedanib esilate Boehringer Ingelheim Pty Ltd PM-2014-01847-1-4 New chemical entity 08/02/16
Vastreka / Soolantra Ivermectin Galderma Australia Pty Ltd PM-2014-01877-1-2 Major variation (new dose form, new indications) 09/12/15
Vectibix Panitumumab Amgen Australia Pty Ltd PM-2010-01972-3-4 Major variation (extension of indications) 07/05/12
Velcade Bortezomib Janssen-Cilag Pty Ltd PM-2010-03250-3-4 Extension of indications 30/11/11
Velcade Bortezomib Janssen-Cilag Pty Ltd PM-2011-00854-3-4 Major variation (route of administration) 16/01/13
Velcade Bortezomib Janssen-Cilag Pty Ltd PM-2014-03463-1-4 Extension of indications 26/02/16
Velphoro Sucroferric oxyhydroxide Vifor Pharma Pty Ltd PM-2013-03249-1-3 New chemical entity 19/02/15
Vfend Voriconazole Pfizer Australia Pty Ltd PM-2011-03524-3-2 Extension of indications 21/05/13
Victoza Liraglutide (rys) Novo Nordisk Pharmaceuticals Pty Ltd PM-2008-2113-5 New biological entity 22/11/10
Victrelis Boceprevir Merck Sharp & Dohme (Australia) Pty Ltd PM-2010-03273-3-2 New chemical entity 23/04/12
Vidaza Azacitidine Celgene Pty Ltd PM-2012-00341-3-4 Major variation (route of administration) 20/08/13
Viekira Pak Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) AbbVie Pty Ltd PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
Viekira Pak Ritonavir / Ombitasvir / Paritaprevir and Dasabuvir (as sodium salt) AbbVie Pty Ltd PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
Viekira Pak Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir (as sodium salt) AbbVie Pty Ltd PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
Viekira Pak Dasabuvir (as sodium salt) and Paritaprevir / Ritonavir / Ombitasvir AbbVie Pty Ltd PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
Viekira Pak-RBV Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin AbbVie Pty Ltd PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
Viekira Pak-RBV Ritonavir / Paritaprevir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin AbbVie Pty Ltd PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
Viekira Pak-RBV Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir (as sodium salt) and Ribavirin AbbVie Pty Ltd PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
Viekira Pak-RBV Dasabuvir (as sodium salt) and Ribavirin and Paritaprevir / Ritonavir / Ombitasvir AbbVie Pty Ltd PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
Viekira Pak-RBV Ribavirin and Dasabuvir (as sodium salt) and Paritaprevir / Ritonavir / Ombitasvir AbbVie Pty Ltd PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
Vimizim Elosulfase alfa (rch) BioMarin Pharmaceutical Australia Pty Ltd PM-2013-02807-1-3 New chemical entity 08/04/15
Vimovo Esomeprazole / Naproxen AstraZeneca Pty Ltd PM 2010-00846-3-3 New fixed combination 09/11/11
Vimovo Naproxen / Esomeprazole AstraZeneca Pty Ltd PM 2010-00846-3-3 New fixed combination 09/11/11
Vipidia / Nesina Alogliptin (as benzoate) Takeda Pharmaceuticals Australia Pty Ltd PM-2012-01949-3-5 New chemical entity 09/01/14
Viramune XR Nevirapine Boehringer Ingelheim Pty Limited PM-2010-03093-3-2 New dosage form 19/03/12
Viread Tenofovir disoproxil fumarate Gilead Sciences Pty Ltd PM-2012-01178-3-2 Extension of indications 14/10/13
Visacor / Crestor Rosuvastatin AstraZeneca Pty Ltd PM-2009-01470-3-3 Extension of indications 25/05/11
Visanne Dienogest Bayer Australia Limited PM-2009-00539-3-5 Extension of indications 21/09/10
Visipaque Iodixanol GE Healthcare Australia Pty Ltd PM-2009-00811-3-2 Extension of indications 14/05/10
Vitekta Elvitegravir Gilead Sciences Pty Ltd PM-2012-02159-3-2 New chemical entity 16/12/13
Volibris Ambrisentan GlaxoSmithKline Australia Pty Ltd PM-2014-04323-1-3 Extension of indications 06/07/17
Vorcon Voriconazole Aspen Pharma Pty Ltd PM-2015-00409-1-2 New generic medicine 29/06/17
Votrient Pazopanib hydrochloride GlaxoSmithKline Australia Pty Ltd PM-2009-01084-4 New chemical entity 01/09/10
Votrient Pazopanib hydrochloride GlaxoSmithKline Australia Pty Ltd PM-2011-01972-3-4 Extension of indications 25/02/13
VPRIV Velaglucerase alfa (ghu) Shire Australia Pty Ltd PM-2010-03810-3-3 New chemical entity (biological) 07/05/12
Vytorin Ezetimibe/ Simvastatin Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01219-3-1 Extension of indications 28/02/13
Vytorin Simvastatin / Ezetimibe Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01219-3-1 Extension of indications 28/02/13
Vyvanse Lisdexamfetamine dimesilate Shire Australia Pty Ltd PM-2012-01494-3-1 New chemical entity 23/10/13

W

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Winglore / Yervoy Ipilimumab Bristol-Myers Squibb Australia Pty Ltd PM-2010-02212-3-4 New biological entity 10/08/11
Winglore/Yervoy Ipilimumab (rch) Bristol-Myers Squibb Australia Pty Ltd PM-2013-04125-1-4 Major variation (new indication) 06/02/17
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) 23/03/11

X

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Xalkori Crizotinib Pfizer Australia Pty Ltd PM-2011-02752-3-4 New chemical entity 12/03/14
Xarelto Rivaroxaban Bayer Australia Limited PM-2010-03901-3-3 Extension of indications 13/09/12
Xarelto Rivaroxaban Bayer Australia Limited PM-2012-01179-3-3 Extension of indications 02/10/13
Xarelto Rivaroxaban Bayer Australia Limited PM-2011-03916-3-3 Extension of indications, New strength 11/11/13
Xelezor / Tesozor / Juvicor Sitagliptin / Simvastatin Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-02796-3-5 New fixed combination 06/06/13
Xeljanz Tofacitinib (as citrate) Pfizer Australia Pty Ltd PM-2012-00788-3-3 New chemical entity 06/03/15
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) 23/03/11
Xeomin Botulinum toxin type A Merz Australia Pty Ltd PM-2012-04159-1-1 10 New chemical entity 10/09/15
Xevex / Daxas / Dalveza Roflumilast Nycomed Pty Ltd PM-2009-02915-3-5 New chemical entity 20/12/11
Xgeva Denosumab Amgen Australia Pty Ltd PM-2010-02051-3-4 New indication, New strength 30/11/11
Xgeva Denosumab Amgen Australia Pty Ltd PM-2012-04329-1-4 Extension of indications 17/04/14
Xiaflex Collagenase clostridium histolyticum Actelion Pharmaceuticals Australia Pty Ltd PM-2012-01472-3-3 New biological entity 18/11/13
Xiaflex Collagenase clostridium histolyticum Actelion Pharmaceuticals Australia Pty Ltd PM-2014-04262-1-3 Extension of indications 02/08/16
Xifaxan Rifaximin Norgine Pty Ltd PM-2011-00501-3-1 New chemical entity 19/11/12
Xifaxan Rifaximin Norgine Pty Ltd PM-2014-00379-1-2 Extension of indications 13/10/15
Xigduo XR 10/500, Xigduo XR 10/1000, Xigduo XR 5/1000 Dapagliflozin (as propanediol monohydrate) / Metformin hydrochloride (HCl) AstraZeneca Pty Ltd PM-2013-01515-1-5 Fixed dose combination 17/12/14
Xigduo XR 10/500, Xigduo XR 10/1000, Xigduo XR 5/1000 Metformin hydrochloride (HCl) / Dapagliflozin (as propanediol monohydrate) AstraZeneca Pty Ltd PM-2013-01515-1-5 Fixed dose combination 17/12/14
Xiliarx / Galvus Vildagliptin Novartis Pharmaceuticals Australia Pty Limited PM-2009-00158-3-5 New chemical entity 23/02/10
Xofigo Radium (223Ra) dichloride Bayer Australia Limited PM-2013-00738-1-2 New chemical entity 10/07/14
Xolair Omalizumab (rch) Novartis Pharmaceuticals Pty Ltd PM-2013-03254-1-4 Major variation (extension of indications) 21/07/15
Xolair Omalizumab (rch) Novartis Australia Pty Ltd PM-2014-03868-1-5 Extension of indications 22/06/16
Xtandi Enzalutamide Astellas Pharma Australia Pty Ltd PM-2013-01155-1-4 New chemical entity 24/11/14
Xtandi Enzalutamide Astellas Pharma Australia Pty Ltd PM-2014-03154-1-4 Extension of indications 23/03/16

Y

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
YAZFlex Drospirenone and ethinyloestradiol (as betadex clathrate) Bayer Australia Ltd PM-2010-03613-3-5 Change in dosage regimen 14/10/14
YAZFlex Ethinyloestradiol (as betadex clathrate) and Drospirenone Bayer Australia Ltd PM-2010-03613-3-5 Change in dosage regimen 14/10/14
Yervoy / Winglore Ipilimumab Bristol-Myers Squibb Australia Pty Ltd PM-2010-02212-3-4 New biological entity 10/08/11
Yervoy/ Winglore Ipilimumab (rch) Bristol-Myers Squibb Australia Pty Ltd PM-2013-04125-1-4 Major variation (new indication) 06/02/17
Yondelis Trabectedin Janssen-Cilag Pty Ltd PM-2009-01976-3-4 New chemical entity 09/11/10

Z

Product Name Active Ingredient Sponsor Submission Number Submission Type AusPAR Date
Zafrez / Cosentyx Secukinumab Novartis Pharmaceutical Australia Pty Ltd PM-2013-04153-1-4 New chemical entity 16/09/15
Zafrez / Cosentyx Secukinumab Novartis Pharmaceuticals Australia Pty Ltd PM-2015-00766-1-3 / 2015-00777-1-3 Extension of indications 25/10/16
Zaldiar Tramadol hydrochloride / Paracetamol Grunenthal Pty Ltd PM-2010-3272-3-1 New fixed combination 13/09/12
Zaldiar Paracetamol / Tramadol hydrochloride Grunenthal Pty Ltd PM-2010-3272-3-1 New fixed combination 13/09/12
Zaltrap / Aflitiv / Lidaveg Aflibercept (rch) Sanofi-Aventis Australia Pty Ltd PM-2011-04301-3-4 New biological entity 29/07/13
Zarzio Filgrastim (rbe) Sandoz Pty Ltd PM-2011-03860-3-4 New Similar Biological Medicinal Product 03/10/13
Zavesca Miglustat Actelion Pharmaceuticals Australia Pty Ltd PM-2008-3187-1 Extension of indications 09/03/10
Zelboraf Vemurafenib Roche Products Pty Ltd PM-2011-00795-3-4 New chemical entity 17/12/12
Zeldox IM Ziprasidone mesilate Pfizer Australia Pty Ltd PM-2008-1737-1 New dosage form 18/12/09
Zepatier Grazoprevir / Elbasvir Merck Sharp and Dohme Australia Pty Ltd PM-2015-02428-1-2 New chemical entity 15/05/17
Zepatier Elbasvir / Grazoprevir Merck Sharp and Dohme Australia Pty Ltd PM-2015-02428-1-2 New chemical entity 15/05/17
Zerbaxa Ceftolozane (as sulfate) / Tazobactam (as sodium salt) Merck Sharp & Dohme Australia Pty Ltd PM-2014-03153-1-2 New chemical entity 27/01/16
Zerbaxa Tazobactam (as sodium salt) / Ceftolozane (as sulfate) Merck Sharp & Dohme Australia Pty Ltd PM-2014-03153-1-2 New chemical entity 27/01/16
Zeteze Composite Pack/Atozet Composite Pack Ezetimibe + atorvastatin as calcium Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-04091-3-3 New fixed dose combination 28/05/13
Zevtera Ceftobiprole medocaril sodium JACE Pharma Pty Ltd PM-2014-03155-1-2 New chemical entity 08/02/16
Zinbryta Daclizumab Biogen Australia Pty Ltd PM-2015-01556-1 New chemical entity 04/05/17
Zinforo Ceftaroline fosamil AstraZeneca Pty Ltd PM-2011-03149-3-2 New chemical entity 22/05/13
Zoely Nomegestrol acetate / Oestradiol Merck Sharp & Dohme (Australia) Pty Ltd PM-2010-00254-3-5 New chemical entity 04/10/11
Zoely Oestradiol / Nomegestrol acetate Merck Sharp & Dohme (Australia) Pty Ltd PM-2010-00254-3-5 New chemical entity 04/10/11
Zomacton Somatropin Ferring Pharmaceuticals Pty Ltd PM-2008-2954-5 Major variation (new strength, new mode of administration) 01/12/10
Zonegran Zonisamide SciGen Australia Pty Ltd PM-2011-03861-3-1 Extension of indications 22/07/13
Zurampic Lesinurad AstraZeneca Pty Ltd PM-2014-04708-1-3 New chemical entity 20/09/16
Zydelig Idelalisab Gilead Sciences Pty Ltd PM-2013-04151-1-4 New chemical entity 14/07/15
Zytiga Abiraterone acetate Janssen-Cilag Pty Ltd PM-2010-03604-3-4 New chemical entity 04/10/12
Zytiga Abiraterone acetate Janssen-Cilag Pty Ltd PM-2012-02706-3-4 Extension of indications 22/01/14