Browse AusPARs by active ingredient

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 active ingredient is the component in the medicine that makes it work.

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

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Abacavir sulfate / Lamivudine / Dolutegravir sodium Triumeq ViiV Healthcare Pty Ltd PM-2013-04112-1-2 New fixed dose combination 19/05/15
Abatacept (rch) Orencia Bristol-Myers Squibb Australia Pty Ltd PM-2010-03115-3-3 Major variation (new dosage form, new route of administration) 26/04/12
Abatacept (rch) Orencia Bristol-Myers Squibb Australia Pty Ltd PM-2008-03683-3-3 Extension of indications 04/03/10
Abatacept (rch) Orencia Bristol-Myers Squibb Australia Pty Ltd PM-2010-00413-3-3 Extension of indications 15/06/11
Abiraterone acetate Zytiga Janssen-Cilag Pty Ltd PM-2010-03604-3-4 New chemical entity 04/10/12
Abiraterone acetate Zytiga Janssen-Cilag Pty Ltd PM-2012-02706-3-4 Extension of indications 22/01/14
Aclidinium bromide Bretaris Genuair A Menarini Australia Pty Ltd PM-2012-04170-1-5 New chemical entity 08/09/14
Adalimumab Humira AbbVie Pty Ltd PM-2013-01154-1-1 Extension of indications, New strength 05/08/14
Adalimumab Humira AbbVie Pty Ltd PM-2015-01149-1-3 Extension of indications 20/03/17
Adalimumab Humira Abbott Australasia Pty Ltd (AbbVie Pty Ltd) PM-2012-02255-3-3 Extension of indications 22/01/14
Adalimumab (rch) Humira AbbVie Pty Ltd PM–2014-04326-1-4 Major variation; extension of indications 12/07/16
Adalimumab (rch) Humira AbbVie Pty Ltd PM-2014-01048-1-3 Extension of indications 10/12/15
Adalimumab (rch) Humira AbbVie Pty Ltd PM-2012-01954-3-1 Extension of indications 25/10/13
Adefovir dipivoxil Hepsera Gilead Sciences Pty Ltd PM-2009-00296-3-2 Extension of indications 29/04/10
Afatinib (as dimaleate) Giotrif Boehringer Ingelheim Pty Limited PM-2012-02708-3-4 New chemical entity 14/04/14
Aflibercept Eylea Bayer Australia Limited PM-2010-03802-3-5 New chemical entity 30/07/12
Aflibercept Eylea Bayer Australia Ltd PM-2013-04198-1-1 Extension of indications 21/07/15
Aflibercept (rch) Eylea Bayer Australia Limited PM-2012-03146-3-5 Extension of indications, Changes to Product Information 04/08/14
Aflibercept (rch) Aflitiv / Lidaveg / Zaltrap Sanofi-Aventis Australia Pty Ltd PM-2011-04301-3-4 New biological entity 29/07/13
Aflibercept (rch) Lidaveg / Zaltrap / Aflitiv Sanofi-Aventis Australia Pty Ltd PM-2011-04301-3-4 New biological entity 29/07/13
Aflibercept (rch) Zaltrap / Aflitiv / Lidaveg Sanofi-Aventis Australia Pty Ltd PM-2011-04301-3-4 New biological entity 29/07/13
Agalsidase alfa ghu Replagal Shire Australia Pty Ltd PM-2009-01140-3-3 New manufacturing process 18/06/10
Agomelatine Valdoxan Servier Laboratories (Aust) Pty Ltd PM-2009-00483-3-1 New chemical entity 21/10/10
Albumin (human) Albumex 20 / Albumex 5 / Albumex 4 CSL Limited PM-2010-02082-3-5 Extension of indications 27/07/11
Alemtuzumab (rch) Lemtrada Sanofi-Aventis Australia Pty Ltd PM-2012-02297-3-1 New dosage strength, New patient group, New dosage regime 04/02/14
Alemtuzumab (rch) Remniq Sanofi-Aventis Australia Pty Ltd PM-2012-02297-3-1 New dosage strength, New patient group, New dosage regime 04/02/14
Alendronic acid Alendraccord / Alendrocor / Pharmacor Alendronate Accord Healthcare Pty Ltd PM-2009-01135-3-5 New generic 16/02/11
Alendronic acid Pharmacor Alendronate / Alendraccord / Alendrocor Accord Healthcare Pty Ltd PM-2009-01135-3-5 New generic 16/02/11
Alirocumab (rch) Praluent (Golyra/Eliriduc) Sanofi-Aventis Australia Pty Ltd PM-2015-00764-1-3 New biological entity 13/12/16
Aliskiren (as hemifumarate) / Hydrochlorothiazide Enviage HCT / Rasilez HCT Novartis Pharmaceuticals Australia Pty Limited PM-2008-2072-3 New fixed combination 12/03/10
Aliskiren (as hemifumarate) / Hydrochlorothiazide Rasilez HCT / Enviage HCT Novartis Pharmaceuticals Australia Pty Limited PM-2008-2072-3 New fixed combination 12/03/10
Aliskiren / Amlodipine Rasilamlo Novartis Pharmaceuticals Australia Pty Limited PM-2010-00719-3-3 New fixed combination 05/08/11
Aliskiren / Amlodipine / Hydrochlorothiazide Rasilamlo HCT Novartis Pharmaceuticals Australia Pty Limited PM-2010-02677-3-3 New combination of active ingredients 15/06/12
Allergen pollen extract of 5 grasses Oralair Sublingual Tablets Helex-A Pty Ltd PM-2009-03500-3-2 New route of administration, New dosage form 15/06/11
Alogliptin (as benzoate) Nesina / Vipidia Takeda Pharmaceuticals Australia Pty Ltd PM-2012-01949-3-5 New chemical entity 09/01/14
Alogliptin (as benzoate) Vipidia / Nesina Takeda Pharmaceuticals Australia Pty Ltd PM-2012-01949-3-5 New chemical entity 09/01/14
Alprostadil Proshaeos Commercial Eyes Pty Ltd PM-2014-03512-1-3 Major variation 09/06/16
Alteplase Actilyse Boehringer Ingelheim Pty Limited PM-2009-02729-3-1 Extension of indications 28/09/10
Amino acids, Lipids and Glucose, with and without Electrolytes PeriOlimel N4-600E, Olimel N5-860E, Olimel N7-960, Olimel N7-960E, Olimel N9-840,Olimel N9-840E Baxter Healthcare Pty Ltd PM-2012-00805-3-1 New fixed combination 02/10/13
Aminolevulinic acid HCl Gliolan Specialised Therapeutics Australia Pty Ltd PM-2012-03095-1-2 New chemical entity 03/03/14
Aminoven 10% (with or without electrolytes) / SMOFlipid 20% / glucose 42% SmofKabiven / SmofKabiven Electrolyte Free Emulsion Fresenius Kabi Australia Pty Ltd PM-2010-02110-3-1 New fixed combination 15/03/12
Amlodipine (as besilate) / Hydrochlorothiazide / Olmesartan medoxomil Sevikar HCT Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-01550-3-3 New fixed dose combination 18/11/13
Amlodipine (as besylate) / Perindopril arginine Coveram Servier Laboratories (Aust) Pty Ltd PM-2008-2262-3 New combination 13/11/09
Amlodipine (as besylate) / Valsartan / Hydrochlorothiazide Exforge HCT / Ejocia HCT Novartis Pharmaceuticals Australia Pty Limited PM-2008-03499-3-3 New fixed combination 26/08/10
Amlodipine (as besylate) / Valsartan / Hydrochlorothiazide Ejocia HCT / Exforge HCT Novartis Pharmaceuticals Australia Pty Limited PM-2008-03499-3-3 New fixed combination 26/08/10
Amlodipine / Aliskiren Rasilamlo Novartis Pharmaceuticals Australia Pty Limited PM-2010-00719-3-3 New fixed combination 05/08/11
Amlodipine / Aliskiren / Hydrochlorothiazide Rasilamlo HCT Novartis Pharmaceuticals Australia Pty Limited PM-2010-02677-3-3 New combination of active ingredients 15/06/12
Amlodipine / Telmisartan Twynsta Boehringer Ingelheim Pty Limited PM-2009-03138-3-3 New fixed dose combination 14/02/11
Amlodipine / Valsartan Exforge/Ejocia 5/320 / Exforge/Ejocia 10/320 Novartis Pharmaceuticals Australia Pty Limited PM-2009-01168-3-3 Major variation (new strength) 26/07/10
Amlodipine besylate / Olmesartan medoxomil Sevikar Schering-Plough Pty Ltd PM-2008-03320-3-3 New fixed dose combination 21/09/10
Anagrelide hydrochloride Thromboreductin Orphan Australia Pty Ltd PM-2009-03102-3-4 Orphan drug 07/05/12
Anakinra Kineret A Menarini Australia Pty Ltd PM-2013-04579-1-3 Major variation (extension of indications) 30/10/15
Apixaban Eliquis Bristol-Myers Squibb Australia Pty Ltd PM-2010-01492-3-3 New chemical entity 20/09/11
Apixaban Eliquis Bristol-Myers Squibb Australia Pty Ltd PM-2011-03165-3-3 Extension of indications 21/06/13
Apixaban Eliquis Bristol-Myers Squibb Australia Pty Ltd PM-2014-00349-1-3 Extension of indications 11/11/15
Apremilast Otezla Celgene Pty Ltd PM-2013-04920-1-3 New chemical entity 22/10/15
Aprepitant Emend Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-00237-3-4 Major variation (new dosage regimen, new dosage) 12/11/12
Aripiprazole Abilify Bristol-Myers Squibb Pharmaceuticals Pty Ltd PM-2010-00571-3-1 Extension of indications 03/03/11
Aripiprazole monohydrate Abilify maintena Lundbeck (Australia) Pty Ltd PM-2013-01100-1-1 Major variation (new strength, new dosage form) 25/11/14
Armodafinil Nuvigil Teva Pharmaceuticals Australia Pty Ltd PM-2014-01922-1-1 New chemical entity 26/05/16
Arsenic trioxide Phenasen Phebra Pty Ltd PM-2014-02385-1-4 Extension of indications 16/12/15
Asenapine Saphris Schering-Plough Pty Ltd PM-2009-03233-3-1 New chemical entity 07/03/11
Asfotase alfa (rch) Strensiq Alexion Pharmaceuticals Australia Pty Ltd PM-2014-03845-1-3 New chemical entity 01/07/16
Aspirin / Clopidogrel CoPlavix / DuoCover Sanofi-Aventis Australia Pty Ltd / Bristol-Myers Squibb Australia Pty Ltd PM-2010-00534-3-4 / 2010-00535-3-3 Extension of indications 28/07/11
Aspirin / Clopidogrel DuoCover / CoPlavix 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
Aspirin / Esomeprazole Axanum AstraZeneca Pty Ltd PM-2010-03829-3-3 New fixed combination 09/08/12
Asunaprevir Sunvepra Bristol-Myers Squibb Australia Pty Ltd PM- 2014-00648-1-2 New chemical entity 14/12/15
Atazanavir Reyataz Bristol-Myers Squibb Australia Pty Ltd PM-2012-01034-3-2 Major variation (change in paediatric dosage regimen, PI updates) 21/10/13
Atorvastatin / Ezetimibe Atozet, Zeteze Merck Sharp & Dohme Australia Pty Ltd PM-2013-03231-1-3 New combination of active ingredients 07/08/15
Avanafil Spedra A Menarini Australia Pty Ltd PM-2014-02782-1-3 New chemical entity 27/10/16
Axitinib Inlyta Pfizer Australia Pty Ltd PM-2011-00876-3-4 New chemical entity 12/02/13
Azacitidine Vidaza Celgene Pty Ltd PM-2012-00341-3-4 Major variation (route of administration) 20/08/13
Azelastine hydrochloride / fluticasone propionate Dymista / Dylastine Meda Pharmaceuticals Pty Ltd PM-2012-03466-1-5 New combination of active ingredients 24/07/14
Aztreonam Cayston Gilead Sciences Pty Ltd PM-2007-3666-2 New dosage form 02/02/10

B

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Belatacept Nulojix Bristol-Myers Squibb Australia Pty Ltd PM-2010-03075-3-2 New chemical entity 30/07/12
Belimumab Benlysta GlaxoSmithKline Australia Pty Ltd PM-2010-01980-3-2 New biological entity 31/10/12
Bendamustine hydrochloride Ribomustin Janssen-Cilag Pty Ltd PM-2013-01517-1-4 New chemical entity 06/01/15
Besifloxacin hydrochloride Besivance Bausch & Lomb (Australia) Pty Ltd PM-2012-02740-3-2 New chemical entity 03/02/14
Betamethasone / Calcipotriol (as dipropionate) Daivobet 50/500 LEO Pharma Pty Ltd PM-2011-04144-3-5 Extension of indications 09/08/13
Bevacizumab Avastin Roche Products Pty Ltd PM-2009-00515-3-1 Extension of indications 14/12/09
Bevacizumab Avastin Roche Products Pty Ltd PM-2010-3786-3-4 Extension of indications 06/08/12
Bevacizumab Avastin Roche Products Pty Ltd PM-2013-03227-1-4 Extension of indications 11/03/15
Bevacizumab Avastin Roche Products Australia Pty Ltd PM-2013-00709-1-4 Major variation (extension of indications) 03/11/14
Bevacizumab (rch) Avastin Roche Products Pty Ltd PM-2014-01871-1-4 Major variation (new indication) 10/05/17
Bevacizumab (recombinant humanised) Avastin Roche Products Pty Ltd PM-2011-02308-3-4 Extension of indications 07/03/13
Bevacizumab injection Avastin Roche Products Pty Ltd PM-2012-02716-3-4 Major variation (dosage) 31/03/14
Bimatoprost Latisse Allergan Australia Pty Ltd PM-2012-02668-3-5 Extension of indications 18/07/14
Boceprevir Victrelis Merck Sharp & Dohme (Australia) Pty Ltd PM-2010-03273-3-2 New chemical entity 23/04/12
Bortezomib Velcade Janssen-Cilag Pty Ltd PM-2010-03250-3-4 Extension of indications 30/11/11
Bortezomib Velcade Janssen-Cilag Pty Ltd PM-2011-00854-3-4 Major variation (route of administration) 16/01/13
Bortezomib Velcade Janssen-Cilag Pty Ltd PM-2014-03463-1-4 Extension of indications 26/02/16
Bosentan Tracleer Actelion Pharmaceuticals Australia Pty Ltd PM-2010-02897-3-4 Major variation (extension of indications) 05/09/12
Botulinum toxin type A Xeomin Merz Australia Pty Ltd PM-2012-04159-1-1 10 New chemical entity 10/09/15
Botulinum toxin type A Botox Allergan Australia Pty Ltd PM-2012-01467-3-3 Major variation (extension of indications) 23/10/13
Botulinum toxin type A Botox Allergan Australia Pty Ltd PM-2009-03219-3-1 Extension of indications 15/06/11
Botulinum toxin type A Botox Allergan Australia Pty Ltd PM-2010-03508-3-3 Extension of indications 06/07/12
Brentuximab vedotin Adcetris Takeda Pharmaceuticals Australia Pty Ltd PM-2012-03441-1-4 New chemical entity 19/05/14
Brimonidine (as tartrate) Mirvaso Galderma Australia Pty Ltd PM-2013-01459-1-5 New indication, New dosage form, New formulation, New strength 23/01/15
Brimonidine tartrate Enidin P / Alphagan P Allergan Australia Pty Ltd PM-2008-03768-3-5 New strength, Change in formulation, New trade names 24/05/10
Brimonidine tartrate Alphagan P / Enidin P Allergan Australia Pty Ltd PM-2008-03768-3-5 New strength, Change in formulation, New trade names 24/05/10
Brinzolamide / Timolol Maleate Azarga Alcon Laboratories (Australia) Pty Ltd PM-2008-3124-5 New fixed combination 19/02/10
Brivaracetam Briviact UCB Australia Pty Ltd PM-2015-01568-1-1 New biological entity 07/03/17
Budesonide Budenofalk Orphan Australia Pty Ltd PM-2010-03268-3-1 Major variation (new dose form, new indications) 22/10/12
Budesonide Cortiment Ferring Pharmaceuticals Pty Ltd PM-2014-04155-1-1 Major variation (new dosage form and new indication) 11/01/16
Budesonide / Eformoterol Symbicort Rapihaler AstraZeneca Pty Ltd PM-2008-03789-3-5 New strengths, Extension of indications, New dosing range, Other quality changes 26/02/13
Budesonide / Eformoterol fumarate dihydrate Symbicort Turbuhaler 200/6, 400/12 / Symbicort Rapihaler 200/6 AstraZeneca Pty Ltd PM-2008-1992-5 Extension of indications 20/10/10
Buprenorphine Transtec Mundipharma Pty Ltd PM-2014-03891-1-1 Major variation (new indication, dose form and dose regimen) 13/12/16
Buprenorphine / Naloxone Suboxone Sublingual Film Reckitt Benckiser (Australia) Pty Ltd PM-2009-01902-3-1 New dose form 07/12/10

C

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
C1 esterase inhibitor Cinryze Cedarglen Investments Pty Ltd PM-2010-03159-3-2 New chemical entity 29/07/13
Cabazitaxel Jevtana Sanofi-Aventis Australia Pty Ltd PM-2010-02565-3-4 New chemical entity 09/02/12
Caffeine citrate Cafnea Phebra Pty Ltd PM-2008-2175-5 New chemical entity 17/03/10
Calcipotriol / Betamethasone (as dipropionate) Daivobet 50/500 LEO Pharma Pty Ltd PM-2011-04144-3-5 Extension of indications 09/08/13
Canagliflozin (as hemihydrate) Invokana / Prominad Janssen-Cilag Pty Ltd PM-2012-02210-3-5 New chemical entity 03/03/14
Canagliflozin (as hemihydrate) Prominad / Invokana Janssen-Cilag Pty Ltd PM-2012-02210-3-5 New chemical entity 03/03/14
Canakinumab Ilaris Novartis Pharmaceuticals Australia Pty Ltd PM-2013-01501-1-3 Extension of indications 25/11/14
Capecitabine / Oxaliplatin Xeloda / Eloxatin / Oxaliplatin Dakota / Winthrop Oxaliplatin Roche Products Pty Ltd / Sanofi-Aventis Australia Pty Ltd PM-2010-00909-4/ 2010-02795-4 Major variation (extension of indications, new dosage) 23/03/11
Carglumic acid Carbaglu Emerge Health Pty Ltd PM-2013-02751-1-3 New chemical entity 02/09/15
Catridecacog (rys) NovoThirteen Novo Nordisk Pharmaceuticals Pty Ltd PM-2012-02713-3-4 New chemical (biological) entity 10/04/14
Catumaxomab Removab Biotech Regulatory Solutions PM-2010-03132-3-4 New chemical entity 11/03/14
Ceftaroline fosamil Zinforo AstraZeneca Pty Ltd PM-2011-03149-3-2 New chemical entity 22/05/13
Ceftobiprole medocaril sodium Zevtera JACE Pharma Pty Ltd PM-2014-03155-1-2 New chemical entity 08/02/16
Ceftolozane (as sulfate) / Tazobactam (as sodium salt) Zerbaxa Merck Sharp & Dohme Australia Pty Ltd PM-2014-03153-1-2 New chemical entity 27/01/16
Celecoxib Celebrex Pfizer Australia Pty Ltd PM-2009-01564-3-1 Extension of indications 23/06/10
Certolizumab Cimzia UCB Australia Pty Ltd PM-2013-00286-2-3 Extension of indications 15/08/14
Certolizumab pegol Cimzia UCB Australia Pty Ltd PM-2008-2508-3 New biological entity 22/12/09
Certolizumab pegol (rbe) Cimzia UCB Australia Pty Ltd PM-2013-04590-1-3 Major variation (extension of indications) 02/11/15
Cetuximab Erbitux Merck Serono Australia Pty Ltd PM-2008-03405-3-4 Extension of indications 15/01/10
Cetuximab Erbitux Merck Serono Australia Pty Ltd PM-2009-02587-4 Extension of indications 19/10/11
Cetuximab Erbitux Merck Serono Australia Pty Ltd PM-2012-00340-3-4 Major variation (review of indications, changes to Product Information) 01/10/13
Ciclesonide Omnaris Nycomed Pty Ltd PM-2009-03337-3-5 Extension of indications, New dose form, New route of administration 18/01/12
Cladribine Movectro Merck Serono Australia Pty Ltd PM-2009-02909-3-1 Extension of indications, New dose form, New route of administration 06/07/11
Clevidipine Cleviprex Kendle Australia Pty Ltd PM-2008-3132-3 New chemical entity 12/04/10
Clobazam Frisium Sanofi-Aventis Australia Pty Ltd PM-2011-04302-3-1 Extension of indications 03/10/13
Clobetasol propionate Clobex Galderma Australia Pty Ltd PM-2011-01596-3-5 New chemical entity 22/05/13
Clopidogrel / Aspirin CoPlavix / DuoCover Sanofi-Aventis Australia Pty Ltd / Bristol-Myers Squibb Australia Pty Ltd PM-2010-00534-3-4 / 2010-00535-3-3 Extension of indications 28/07/11
Clopidogrel / Aspirin DuoCover / CoPlavix 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
Cobicistat Tybost Gilead Sciences Pty Ltd PM-2012-02160-3-2 New chemical entity 16/12/13
Cobicistat / Emtricitabine / Tenofovir alafenamide (as fumarate) / Elvitegravir Genvoya Gilead Sciences Pty Ltd PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Cobicistat / Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir Stribild Gilead Sciences Pty Ltd PM-2011-03533-3-2 New fixed dose combination 05/08/13
Colistimethate sodium Tadim Phebra Pty Ltd PM-2009-02764-3-2 New dose form, New route of administration 13/01/11
Collagenase clostridium histolyticum Xiaflex Actelion Pharmaceuticals Australia Pty Ltd PM-2012-01472-3-3 New biological entity 18/11/13
Collagenase clostridium histolyticum Xiaflex Actelion Pharmaceuticals Australia Pty Ltd PM-2014-04262-1-3 Extension of indications 02/08/16
Corifollitropin alfa Elonva Schering-Plough Pty Ltd PM-2009-00870-3-5 New chemical entity 21/07/10
Crizotinib Xalkori Pfizer Australia Pty Ltd PM-2011-02752-3-4 New chemical entity 12/03/14
Cyclizine lactate Valoid Link Medical Products Pty Ltd PM-2010-03573-3-1 New chemical entity 15/01/13
Cyclosporin Restasis Allergan Australia Pty Ltd PM-2009-03746-3-5 Extension of indications, New dosage form 22/11/11

D

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Dabigatran etexilate Pradaxa Boehringer Ingelheim Pty Ltd PM-2013-02038-1-3 Major variation (extension of indications) 04/01/16
Dabigatran etexilate mesilate Pradaxa Boehringer Ingelheim Pty Limited PM-2010-00120-3-3 Extension of indications, New strength, Changes to currently approved strengths 24/05/11
Dabrafenib mesilate Tafinlar GlaxoSmithKline Australia Pty Ltd PM-2012-02231-3-4 New chemical entity 09/01/14
Daclatasvir dihydrochloride Daklinza Bristol-Myers Squibb Australia Pty Ltd PM-2014-00647-1-2 New chemical entity 14/12/15
Daclizumab Zinbryta Biogen Australia Pty Ltd PM-2015-01556-1 New chemical entity 04/05/17
Dalteparin Fragmin Pfizer Australia Pty Ltd PM-2009-00586-3-3 Extension of indications 27/05/10
Dapagliflozin (as propanediol monohydrate) / Metformin hydrochloride (HCl) Xigduo XR 10/500, Xigduo XR 10/1000, Xigduo XR 5/1000 AstraZeneca Pty Ltd PM-2013-01515-1-5 Fixed dose combination 17/12/14
Dapagliflozin propanediol monohydrate Appebb / AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin / Edistride / Empliciti / Forxiga Bristol-Myers Squibb Australia Pty Ltd PM-2010-03812-35 New chemical entity 14/01/13
Dapagliflozin propanediol monohydrate AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin / Edistride / Empliciti / Forxiga / Appebb Bristol-Myers Squibb Australia Pty Ltd PM-2010-03812-35 New chemical entity 14/01/13
Dapagliflozin propanediol monohydrate Edistride / Empliciti / Forxiga / Appebb / AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin Bristol-Myers Squibb Australia Pty Ltd PM-2010-03812-35 New chemical entity 14/01/13
Dapagliflozin propanediol monohydrate Empliciti / Forxiga / Appebb / AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin / Edistride Bristol-Myers Squibb Australia Pty Ltd PM-2010-03812-35 New chemical entity 14/01/13
Dapagliflozin propanediol monohydrate Forxiga / Appebb / AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin / Edistride / Empliciti Bristol-Myers Squibb Australia Pty Ltd PM-2010-03812-35 New chemical entity 14/01/13
Dapagliflozin propanediol monohydrate BMS-AZ Dapagliflozin / Edistride / Empliciti / Forxiga / Appebb / AZ Dapagliflozin / BMS Dapagliflozin Bristol-Myers Squibb Australia Pty Ltd PM-2010-03812-35 New chemical entity 14/01/13
Dapoxetine Priligy Janssen-Cilag Pty Ltd PM-2007-3614-3 New chemical entity 23/11/10
Dasabuvir (as sodium salt) and Paritaprevir / Ritonavir / Ombitasvir Viekira Pak AbbVie Pty Ltd PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
Dasabuvir (as sodium salt) and Ribavirin and Paritaprevir / Ritonavir / Ombitasvir Viekira Pak-RBV AbbVie Pty Ltd PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
Dasatinib Sprycel Bristol-Myers Squibb Australia Pty Ltd PM-2010-01583-3-4 Major variation (extension of indications) 11/07/11
Deferasirox Exjade Novartis Pharmaceuticals Australia Pty Limited PM-2012-03063-1-4 Extension of indications 06/03/14
Deferiprone Ferriprox Orphan Australia Pty Ltd PM-2010-00539-3-4 Extension of indications, Increase in dosage, Changes to Product Information 04/10/11
Degarelix Firmagon Ferring Pharmaceuticals Pty Ltd PM-2008-2254-4 New chemical entity 16/02/10
Denosumab Prolia Amgen Australia Pty Ltd PM-2009-00390-3-5 New biological entity 26/10/10
Denosumab Xgeva Amgen Australia Pty Ltd PM-2010-02051-3-4 New indication, New strength 30/11/11
Denosumab Prolia Amgen Australia Pty Ltd PM-2012-02302-3-5 Extension of indications 28/01/14
Denosumab Xgeva Amgen Australia Pty Ltd PM-2012-04329-1-4 Extension of indications 17/04/14
Deoxycholic acid Belkyra Allergan Australia Pty Ltd PM-2014-04251-1-5 New chemical entity 06/04/17
Dexamethasone Ozurdex Allergan Australia Pty Ltd PM-2014-00332-1-5 Extension of indications 25/10/16
Dexamethasone Ozurdex Allergan Australia Pty Ltd PM-2009-00795-3-5 Extension of indications, New dose form, New route of administration 19/10/11
Dienogest Visanne Bayer Australia Limited PM-2009-00539-3-5 Extension of indications 21/09/10
Dienogest / Oestradiol valerate Qlaira Bayer Australia Limited PM-2009-02910-3-5 Extension of indications 28/03/11
Digoxin-specific antibody fragment F(Ab) (Ovine) DigiFab Phebra Pty Ltd PM-2012-03387-1-3 New biological entity 05/05/14
Dimethyl fumarate Tecfidera Biogen Idec Australia Pty Ltd PM-2012-00808-3-1 New chemical entity 22/10/13
Diphtheria toxoid / Haemophilus type B polysaccharide / hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid Hexaxim Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Docetaxel Docetaxel-PF Pfizer Australia Pty Ltd PM-2011-01623-3-4 New generic 13/05/13
Dolutegravir (as sodium) Tivicay ViiV Healthcare Pty Ltd PM-2012-04124-1-2 New chemical entity 19/05/14
Dolutegravir sodium / Abacavir sulfate / Lamivudine Triumeq ViiV Healthcare Pty Ltd PM-2013-04112-1-2 New fixed dose combination 19/05/15
Doxycycline monohydrate Oracea Galderma Australia Pty Ltd PM-2010-03584-3-4 Extension of indications, New presentation 06/06/13
Dronedarone hydrochloride Multaq / Dronedarone Winthrop / Dronedarone Sanofi Sanofi-Aventis Australia Pty Ltd PM-2008-3045-3 New chemical entity 05/10/10
Dronedarone hydrochloride Dronedarone Winthrop / Dronedarone Sanofi / Multaq Sanofi-Aventis Australia Pty Ltd PM-2008-3045-3 New chemical entity 05/10/10
Drospirenone and ethinyloestradiol (as betadex clathrate) YAZFlex Bayer Australia Ltd PM-2010-03613-3-5 Change in dosage regimen 14/10/14
Dulaglutide rch Trulicity Eli Lilly Australia Ptd Ltd PM-2013-03639-1-5 New chemical entity 27/07/15
Duloxetine Cymbalta Eli Lilly Australia Pty Ltd PM-2010-03270-3-1 Extension of indications 06/09/12
Dutasteride Avodart GlaxoSmithKline Australia Pty Ltd PM-2009-02236-3-3 Extension of indications 22/09/10
Dutasteride / Tamsulosin Duodart GlaxoSmithKline Australia Pty Ltd PM-2009-01559-3-3 New fixed dose combination 20/10/10

E

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Efmoroctocog alfa (rhu) Eloctate Biogen Idec Australia Pty Ltd PM-2013-01157-1-4 New biological entity 17/03/15
Eformoterol / Budesonide Symbicort Rapihaler AstraZeneca Pty Ltd PM-2008-03789-3-5 New strengths, Extension of indications, New dosing range, Other quality changes 26/02/13
Eformoterol fumarate dihydrate / Budesonide Symbicort Turbuhaler 200/6, 400/12 / Symbicort Rapihaler 200/6 AstraZeneca Pty Ltd PM-2008-1992-5 Extension of indications 20/10/10
Eformoterol fumarate dihydrate / Fluticasone propionate Flutiform Mundipharma Pty Ltd PM-2010-03251-3-5 New combination of active ingredients 13/06/13
Eftrenonacog alfa Alprolix Biogen Idec Australia Pty Ltd PM-2013-00745-1-4 New biological entity 03/11/14
Electrolytes (with and without), Glucose, Lipids and Amino acids Olimel N5-860E, Olimel N7-960, Olimel N7-960E, Olimel N9-840,Olimel N9-840E, PeriOlimel N4-600E Baxter Healthcare Pty Ltd PM-2012-00805-3-1 New fixed combination 02/10/13
Eliglustat (as tartrate) Cerdelga / Eliglustat Genzyme Sanofi-Aventis Australia Pty Ltd PM-2013-03651-1-1 New chemical entity 05/08/15
Eliglustat (as tartrate) Eliglustat Genzyme / Cerdelga Sanofi-Aventis Australia Pty Ltd PM-2013-03651-1-1 New chemical entity 05/08/15
Elosulfase alfa (rch) Vimizim BioMarin Pharmaceutical Australia Pty Ltd PM-2013-02807-1-3 New chemical entity 08/04/15
Eltrombopag Revolade Novartis Pharmaceuticals Australia Pty Ltd PM-2014-04303-1-4 Extension of indications 30/03/16
Eltrombopag olamine Revolade GlaxoSmithKline Australia Pty Ltd SM- 2009-00082-3-4 New chemical entity 26/10/10
Eltrombopag olamine Revolade GlaxoSmithKline Australia Pty Ltd PM-2012-01934-3-2 Major variation (extension of indications) 03/12/13
Elvitegravir Vitekta Gilead Sciences Pty Ltd PM-2012-02159-3-2 New chemical entity 16/12/13
Elvitegravir / Cobicistat / Emtricitabine / Tenofovir alafenamide (as fumarate) Genvoya Gilead Sciences Pty Ltd PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Elvitegravir / Tenofovir disoproxil fumarate / Emtricitabine / Cobicistat Stribild Gilead Sciences Pty Ltd PM-2011-03533-3-2 New fixed dose combination 05/08/13
Empagliflozin Jardiance Boehringer Ingelheim Pty Ltd PM-2013-00674-1-5 New chemical entity 27/01/15
Emtricitabine Emtriva Gilead Sciences Pty Ltd PM-2012-02513-3-2 Major variation (extension of indications) 12/06/14
Emtricitabine / rilpivirine / tenofovir disoproxil fumarate Eviplera Gilead Sciences Pty Ltd PM-2013-01524-1-2 Extension of indications 15/07/14
Emtricitabine / Tenofovir alafenamide (as fumarate) Descovy Gilead Sciences Pty Ltd PM-2015-01283-1-3 New fixed dose combination 20/12/16
Emtricitabine / Tenofovir alafenamide (as fumarate) / Elvitegravir / Cobicistat Genvoya Gilead Sciences Pty Ltd PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Emtricitabine / Tenofovir disoproxil fumarate Truvada Gilead Sciences Pty Ltd PM-2015-00411-1-2 Extension of indications 10/11/16
Emtricitabine / Tenofovir disoproxil fumarate / rilpivirine Eviplera Gilead Sciences Pty Ltd PM-2010-02853-3-2 New chemical entity 27/03/12
Emtricitabine / Tenofovir disoproxil fumarate/ Elvitegravir / Cobicistat Stribild Gilead Sciences Pty Ltd PM-2011-03533-3-2 New fixed dose combination 05/08/13
Enzalutamide Xtandi Astellas Pharma Australia Pty Ltd PM-2013-01155-1-4 New chemical entity 24/11/14
Enzalutamide Xtandi Astellas Pharma Australia Pty Ltd PM-2014-03154-1-4 Extension of indications 23/03/16
Eplerenone Inspra Pfizer Australia Pty Ltd PM-2011-04066-3-3 Extension of indications 01/10/13
Eribulin mesilate Halaven Eisai Australia Pty Ltd PM-2011-01624-3-4 New chemical entity 17/05/13
Erlotinib Tarceva Roche Products Pty Ltd PM-2009-00835-3-4 Extension of indications 09/11/10
Erlotinib Tarceva Roche Products Pty Ltd PM-2011-01993-3-4 Extension of indications 07/01/13
Esomeprazole / Aspirin Axanum AstraZeneca Pty Ltd PM-2010-03829-3-3 New fixed combination 09/08/12
Esomeprazole / Naproxen Vimovo AstraZeneca Pty Ltd PM 2010-00846-3-3 New fixed combination 09/11/11
Etanercept Enbrel Pfizer Australia Pty Ltd PM-2010-03845-3-4 Extension of indications 19/03/12
Etanercept Enbrel Pfizer Australia Pty Ltd PM-2013-04552-1-3 Extension of indications 23/09/15
Etanercept Enbrel Wyeth Australia Pty Ltd PM-2008-03723-3-4 Extension of indications 16/02/10
Etanercept (rch) Enbrel Pfizer Australia Pty Ltd PM-2012-04135-1-3 Extension of indications 24/03/14
Ethinyloestradiol (as betadex clathrate) and Drospirenone YAZFlex Bayer Australia Ltd PM-2010-03613-3-5 Change in dosage regimen 14/10/14
Everolimus Afinitor Novartis Pharmaceuticals Australia Pty Limited PM-2011-01215-3-4 Extension of indications 26/02/13
Everolimus Certican Novartis Pharmaceuticals Australia Pty Limited PM-2011-03534-3-2 Extension of indications, New dosage recommendations, Changes to Product Information 21/05/13
Everolimus Afinitor Novartis Pharmaceuticals Australia Pty Limited PM-2012-00337-3-4 Extension of indications 22/08/13
Evolocumab (rch) Repatha Amgen Australia Pty Ltd PM-2014-03144-1-3 New biological entity 03/05/16
Exenatide Byetta / Bydureon Eli Lilly Australia Pty Ltd PM-2010-02389-3-5 Extension of indications, New dosage form 05/02/13
Exenatide Byetta Eli Lilly Australia Pty Ltd PM-2011-01931-3-5 Major variation (extension of indications) 03/06/13
Ezetimibe Ezetrol Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01220-3-3 Extension of indications 28/02/13
Ezetimibe + atorvastatin as calcium Atozet Composite Pack/Zeteze Composite Pack Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-04091-3-3 New fixed dose combination 28/05/13
Ezetimibe + atorvastatin as calcium Zeteze Composite Pack/Atozet Composite Pack Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-04091-3-3 New fixed dose combination 28/05/13
Ezetimibe / Atorvastatin Atozet, Zeteze Merck Sharp & Dohme Australia Pty Ltd PM-2013-03231-1-3 New combination of active ingredients 07/08/15
Ezetimibe / Rosuvastatin (as calcium) Ezalo, Rosuzet Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-02434-1-3 New fixed dose combination 29/01/15
Ezetimibe / Rosuvastatin (as calcium) Rosuzet, Ezalo Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-02434-1-3 New fixed dose combination 29/01/15
Ezetimibe and rosuvastatin (as calcium) Ezalo Composite Pack / Rosuzet Composite Pack Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-03419-1-3 New combination of active ingredients 05/03/14
Ezetimibe/ Simvastatin Vytorin Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01219-3-1 Extension of indications 28/02/13

F

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Fampridine Fampyra Biogen Idec Australia Pty Ltd PM-2010-00524-3-1 New chemical entity 15/06/11
Febuxostat (FBX) Adenuric A Menarini Australia Pty Ltd PM-2012-03425-1-3 New chemical entity 08/01/15
Fenofibrate Lipidil Abbott Australasia Pty Ltd PM-2012-02387-3-5 Extension of indications 14/04/14
Fentanyl (as citrate) PecFent ERA Consulting (Australia) Pty Ltd PM-2011-00911-3-1 Major variation (new dosage form) 19/03/13
Fentanyl (as citrate) Pecfent AstraZeneca Pty Ltd PM-2013-01123-1-1 Major variation 20/05/14
Fentanyl citrate Abstral A. Menarini Australia Pty Ltd PM-2011-03151-3-1 Major variation (new dosage form) 30/10/13
Fentanyl citrate Instanyl Takeda Pharmaceuticals Australia Pty Ltd PM-2012-00804-3-1 Major variation (new dose form) 11/11/13
Fentanyl citrate Fentora Orphan Australia Pty Ltd PM-2013-03632-1-1 New dose form, New route of administration 22/04/15
Ferric carboxymaltose Ferinject Vifor Pharma Pty Ltd PM-2009-01623-3-4 New chemical entity 24/05/11
Fibrin adhesive/sealant Artiss Baxter Healthcare Pty Ltd PM-2010-03599-3-4 Extension of indications 09/02/12
Fibrin haemostatic agent/sealant Evicel Johnson & Johnson Medical Pty Ltd PM-2009-03561-3-4 New chemical entity 11/12/12
Fibrin sealant Tisseel VH/SD Baxter Healthcare Pty Ltd PM-2009-00290-3-4 Extension of indications 06/04/10
Fibrin sealant Artiss Baxter Healthcare Pty Ltd PM-2009-01572-3-4 New biological entity 03/08/10
Fibrin sealant / adhesive / haemostatic agent Tisseel VH/SD Baxter Healthcare Pty Ltd PM-2010-03271-3-4 Extension of indications, Additional method of administration 03/05/12
Fidaxomicin Dificid Specialised Therapeutics Australia Pty Ltd PM-2012-04269-3-2 New chemical entity 26/09/13
Filgrastim Nivestim Hospira Pty Ltd PM-2009-00676-3-4 New chemical entity (biosimilar product) 13/09/10
Filgrastim Tevagrastim Aspen Pharmacare Australia Pty Ltd PM-2009-1996-3-4 Similar biological medicinal product 17/10/11
Filgrastim (rbe) Zarzio Sandoz Pty Ltd PM-2011-03860-3-4 New Similar Biological Medicinal Product 03/10/13
Fingolimod Filosir / Fynefta / Gilenya Novartis Pharmaceuticals Australia Pty Limited PM-2010-00401-3-1 New chemical entity 29/03/11
Fingolimod Fynefta / Filosir / Gilenya Novartis Pharmaceuticals Australia Pty Limited PM-2010-00401-3-1 New chemical entity 29/03/11
Fingolimod Gilenya / Fynefta/ Filosir Novartis Pharmaceuticals Australia Pty Limited PM-2010-00401-3-1 New chemical entity 29/03/11
Fish oil / Olive oil / Soya oil / Medium chain triglycerides SMOFlipid Fresenius Kabi Australia Pty Ltd PM-2008-03674-3-1 New combination 10/06/10
Fluticasone furoate / vilanterol trifenatate Breo Ellipta GlaxoSmithKline Australia Pty Ltd PM-2012-01970-3-5 New chemical entity, New combination 25/06/14
Fluticasone propionate / azelastine hydrochloride Dymista/Dylastine Meda Pharmaceuticals Pty Ltd PM-2012-03466-1-5 New combination of active ingredients 24/07/14
Fluticasone propionate / Eformoterol fumarate dihydrate Flutiform Mundipharma Pty Ltd PM-2010-03251-3-5 New combination of active ingredients 13/06/13
Follitropin alfa (rch) Afolia / Bemfola Finox Biotech Australia Pty Ltd PM-2014-03163-1-5 Biosimilar medicine, Extension of indications 08/04/16
Follitropin alfa (rch) Bemfola / Afolia Finox Biotech Australia Pty Ltd PM-2014-03163-1-5 Biosimilar medicine, Extension of indications 08/04/16
Follitropin alfa (rch) / Lutropin alfa (rch) Pergoveris Merck Serono Australia Pty Ltd PM-2008-1439-5 New fixed combination 11/01/10

G

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Gadobutrol Gadovist 1.0 Bayer Australia Ltd PM-2015-01572-1-2 Major variation 31/01/17
Gadobutrol Gadovist Bayer Australia Ltd PM-2013-04968-1-2 Extension of indications 01/06/15
Gefitinib Iressa AstraZeneca Pty Ltd PM-2009-02058-3-4 Extension of indications 29/06/10
Gliclazide Gliclazide Gppl MR 30 Generic Partners Pty Ltd PM-2015-00426-1-5 New generic medicine 19/07/16
Glucose 42% / SMOFlipid 20% / Aminoven 10% (with or without electrolytes) SmofKabiven / SmofKabiven Electrolyte Free Emulsion Fresenius Kabi Australia Pty Ltd PM-2010-02110-3-1 New fixed combination 15/03/12
Glucose, Lipids and Amino acids, with and without Electrolytes Olimel N5-860E, Olimel N7-960, Olimel N7-960E, Olimel N9-840,Olimel N9-840E, PeriOlimel N4-600E Baxter Healthcare Pty Ltd PM-2012-00805-3-1 New fixed combination 02/10/13
Glycopyrronium (as bromide) Seebri Breezhaler / Tovanor Breezhaler Novartis Pharmaceuticals Australia Pty Limited PM-2011-02800-3-5 New chemical entity 10/07/13
Glycopyrronium (as bromide) Tovanor Breezhaler/Seebri Breezhaler Novartis Pharmaceuticals Australia Pty Limited PM-2011-02800-3-5 New chemical entity 10/07/13
Glycopyrronium bromide / Indacaterol maleate Ultibro Breezhaler 110/50 Novartis Pharmaceuticals Australia Pty Ltd PM-2012-04395-1-5 New combination of active ingredients 23/10/14
Golimumab Simponi Schering-Plough Pty Ltd PM-2008-1811-3 New biological entity 14/12/09
Golimumab (rmc) Simponi and Simponi Smartject Injector Janssen-Cilag Pty Ltd PM-2012-01202-3-3 Extension of indications, Changes to Product Information 16/08/13
Golimumab (rmc) Simponi, Simponi smartject injector Janssen-Cilag Pty Ltd PM-2013-00215-1-1 Major variation (extension of indications) 19/05/14
Gonadotrophin - human menopausal Menopur Ferring Pharmaceuticals Pty Ltd PM-2009-01335-3-5 New chemical entity 12/10/11
Granisetron Sancuso Invida Australia Pty Ltd PM-2009-02620-3-4 New route of administration, New dosage form 21/06/11

H

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Haemophilus type B polysaccharide / hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid Hexaxim Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide Hexaxim Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Hib and group C Meningococcal conjugate vaccine Menitorix GlaxoSmithKline Australia Pty Ltd PM-2009-00817-3-2 New biological entity (new combination vaccine) 02/08/10
Human C1 esterase inhibitor Berinert CSL Limited, Bioplasma Division PM-2008-03232-3-2 New chemical entity 14/01/10
Human fibrinogen RiaSTAP CSL Limited PM-2009-01838-3-4 New chemical entity 13/10/10
Human Fibrinogen / Human Thrombin TachoSil Nycomed Pty Ltd PM-2010-02840-3-4 New fixed combination 31/08/12
Human papillomavirus (Types 6, 11, 16 & 18) quadrivalent recombinant vaccine Gardasil Merck Sharp & Dohme (Australia) Pty Ltd PM-2010-03191-3-2 Extension of indications 07/05/12
Human Papillomavirus 9 valent vaccine Gardasil 9 Merck Sharp & Dohme Australia Pty Ltd PM-2014-01099-1 New biological entity 03/01/17
Human papillomavirus quadrivalent vaccine Gardasil Merck Sharp & Dohme (Australia) Pty Ltd PM-2009-00914-2 Extension of indications 08/10/10
Human papillomavirus vaccine types 16 and 18 (recombinant AS04 adjuvanted) Cervarix GlaxoSmithKline Australia Pty Ltd PM-2014-01893-1-2 Major variation 04/01/16
Human Papillomavirus Vaccine Types 16 and 18 (recombinant, AS04 adjuvanted) Cervarix GlaxoSmithKline Australia Pty Ltd PM-2009-02655-3-2 Major variation (extension of indications) 22/06/11
Human Prothrombin Complex Beriplex P/N CSL Limited, Bioplasma Division PM-2008-2935-4 New chemical entity 15/01/10
Human Thrombin / Human Fibrinogen TachoSil Nycomed Pty Ltd PM-2010-02840-3-4 New fixed combination 31/08/12
Hydrochlorothiazide / Aliskiren (as hemifumarate) Rasilez HCT / Enviage HCT Novartis Pharmaceuticals Australia Pty Limited PM-2008-2072-3 New fixed combination 12/03/10
Hydrochlorothiazide / Aliskiren / Amlodipine Rasilamlo HCT Novartis Pharmaceuticals Australia Pty Limited PM-2010-02677-3-3 New combination of active ingredients 15/06/12
Hydrochlorothiazide / Olmesartan medoxomil / Amlodipine (as besilate) Sevikar HCT Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-01550-3-3 New fixed dose combination 18/11/13
Hydrochlorothiazide / Valsartan / Amlodipine (as besylate) Exforge HCT / Ejocia HCT Novartis Pharmaceuticals Australia Pty Limited PM-2008-03499-3-3 New fixed combination 26/08/10

I

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Ibrutinib Imbruvica Janssen-Cilag Pty Ltd PM-2014-02780-1-4 New chemical entity 02/02/16
Ibuprofen Caldolor Phebra Pty Ltd PM-2010-02393-3-1 Major variation (new dosage form, new route of administration) 02/01/13
Icatibant Firazyr Shire Australia Pty Ltd SM-2009-00755-3-2 New chemical entity 07/06/10
Idarucizumab Praxbind Boehringer Ingelheim Pty Ltd PM-2015-00707-1-3 New biological medicine 25/10/16
Idelalisab Zydelig Gilead Sciences Pty Ltd PM-2013-04151-1-4 New chemical entity 14/07/15
Iloperidone Fanapt Kendle R & D Pty Ltd PM-2010-02772-3 New chemical entity 18/06/12
Imatinib Glivec Novartis Pharmaceuticals Australia Pty Limited PM-2012-02722-3-4 Extension of indications 22/01/14
Imatinib (as mesylate) Glivec Novartis Pharmaceuticals Australia Pty Limited PM-2011-02797-3-4 Major variation (extension of duration of treatment) 04/06/13
Immunoglobulin - normal (human) Intratect Link Medical Products Pty Ltd PM-2009-02495-3-2 New chemical entity 03/02/11
Immunoglobulin - normal (human) Intragam 10 NF CSL Bioplasma Ltd PM-2009-01544-3-2 Extension of indications, New dosage 18/10/11
Immunoglobulin - normal (human) Gamunex Talecris Biotherapeutics Pty Ltd PM-2010-01870-3 -201870-3-2 Extension of indications, New route of administration 13/12/11
Immunoglobulin - normal (human) Evogam CSL Limited PM-2010-01887-3-2 Major variations (new strength, new route of administration, change in manufacture and tradename) 07/05/12
Inactivated influenza vaccine / Split virus / Vero cell derived Preflucel Baxter Healthcare Pty Ltd PM-2010-03274-3-2 New biological entity 06/07/12
Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B) Optaflu Novartis Vaccines & Diagnostics Pty Ltd PM-2013-04969-1-2 New chemical entity 24/08/15
Indacaterol Arbeela Breezhaler / Onbrez Breezhaler Novartis Pharmaceuticals Australia Pty Limited PM-2009-00350-3-5 New chemical entity 27/10/10
Indacaterol Onbrez Breezhaler / Arbeela Breezhaler Novartis Pharmaceuticals Australia Pty Limited PM-2009-00350-3-5 New chemical entity 27/10/10
Indacaterol maleate / Glycopyrronium bromide Ultibro Breezhaler 110/50 Novartis Pharmaceuticals Australia Pty Ltd PM-2012-04395-1-5 New combination of active ingredients 23/10/14
Indomethacin Indocid PDA Invida Australia Pty Ltd PM-2009-03539-3-3 Major variation (change in dosage and patient population) 18/03/11
Infliximab Remicade Janssen-Cilag Pty Ltd PM-2011-00196-3-1 Extension of indications 17/12/12
Influenza virus haemagglutinin (Type A/California/7/2009 (H1N1)v-like strain adjuvanted to ASO3) Pandemrix H1N1 pandemic influenza vaccine GlaxoSmithKline Australia Pty Ltd PM-2010-02995-3-2 Major variation (change in patient group, dosing schedule) 12/02/13
Influenza Virus Haemagglutinin H1N1, H3N2, B Victoria lineage, B Yamagata lineage FluQuadri, FluQuadri Junior Sanofi-Aventis Australia Pty Ltd PM-2013-02401-1-2 New biological entity 06/02/15
Influenza Virus Haemagglutinin H5N1 Aflunov / Prepandemic H5N1 adjuvanted Influenza Vaccine 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
Influenza Virus Haemagglutinin H5N1 Prepandemic H5N1 adjuvanted Influenza Vaccine / Aflunov 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
Influenza virus haemagglutinin inactivated split influenza vaccine Fluarix Tetra GlaxoSmithKline Australia Pty Ltd PM-2012-02287-3-2 New chemical/biological entity 06/02/14
Ingenol mebutate Picato 0.015% and 0.05% gel LEO Pharma Pty Ltd PM-2011-02307-3-5 New chemical entity 06/06/13
Insulin detemir (rys) Levemir Novo Nordisk Pharmaceuticals Pty Ltd PM-2012-02256-3-5 Major variation (change in patient group/pregnancy category) 28/03/14
Insulin glargine Abasria / Abasria KwikPen Eli Lilly Australia Pty Ltd PM-2013-02802-1-5 Biosimilar (Insulin analogue) 20/08/15
Insulin glargine (rbe) Toujeo / Edomlus / Lambeto Sanofi Aventis Australia Pty Ltd PM-2014-00670-1-5 New strength 06/01/17
Insulin glargine (rbe) Edomlus / Lambeto /Toujeo Sanofi Aventis Australia Pty Ltd PM-2014-00670-1-5 New strength 06/01/17
Insulin glargine (rbe) Lambeto /Toujeo / Edomlus Sanofi Aventis Australia Pty Ltd PM-2014-00670-1-5 New strength 06/01/17
Interferon beta-1a Rebif Merck Serono Australia Pty Ltd PM-2012-00320-3-1 Extension of indications 10/10/13
Iodixanol Visipaque GE Healthcare Australia Pty Ltd PM-2009-00811-3-2 Extension of indications 14/05/10
Ipilimumab Winglore / Yervoy Bristol-Myers Squibb Australia Pty Ltd PM-2010-02212-3-4 New biological entity 10/08/11
Ipilimumab Yervoy / Winglore Bristol-Myers Squibb Australia Pty Ltd PM-2010-02212-3-4 New biological entity 10/08/11
Ipilimumab (rch) Yervoy/ Winglore Bristol-Myers Squibb Australia Pty Ltd PM-2013-04125-1-4 Major variation (new indication) 06/02/17
Ipilimumab (rch) Winglore/Yervoy Bristol-Myers Squibb Australia Pty Ltd PM-2013-04125-1-4 Major variation (new indication) 06/02/17
Ivabradine Coralan Servier Laboratories (Aust) Pty Ltd PM-2008-2832-3 Extension of indications 03/09/10
Ivabradine Coralan Servier Laboratories (Aust) Pty Ltd PM-2010-03269-3-3 Major variation (extension of indications) 31/10/12
Ivacaftor Kalydeco Vertex Pharmaceuticals Australia Pty Ltd PM-2012-01491-3-5 New chemical entity 29/11/13
Ivacaftor Kalydeco Vertex Pharmaceuticals Australia PM-2015-00399-1-5 Extension of indications 05/01/17
Ivacaftor / Lumacaftor Orkambi 200/125 Vertex Pharmaceuticals Australia Pty Ltd PM-2015-00424-1-5 New chemical entity in a fixed dose combination 08/09/16
Ivermectin Stromectol Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-01113-3-2 Extension of indications 30/10/13
Ivermectin Soolantra / Vastreka Galderma Australia Pty Ltd PM-2014-01877-1-2 Major variation (new dose form, new indications) 09/12/15
Ivermectin Vastreka / Soolantra Galderma Australia Pty Ltd PM-2014-01877-1-2 Major variation (new dose form, new indications) 09/12/15
IVIg Flebogamma 10% DIF Grifols Australia Pty Ltd PM-2010-03276-3-2 Major variation (new strength) 03/09/13
Ixekizumab Taltz Eli Lilly Australia Pty Ltd PM-2015-01878-1-4 New chemical entity 08/05/17

J

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Japanese Encephalitis Chimeric Virus Imojev Sanofi Pasteur Pty Ltd PM-2009-01554-3-2 New chemical entity 16/08/10
Japanese Encephalitis Vaccine (live, attenuated) Imojev Sanofi-Aventis Australia Pty Ltd PM-2012-02264-3-2 Major variation 03/02/14

L

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Lamivudine / Dolutegravir sodium / Abacavir sulfate Triumeq ViiV Healthcare Pty Ltd PM-2013-04112-1-2 New fixed dose combination 19/05/15
Lanthanum carbonate Fosrenol Shire Australia Pty Ltd PM-2010-01654-3-3 Extension of indications 14/02/12
Lapatinib Tykerb GlaxoSmithKline Australia Pty Ltd PM-2009-01276-3-4 Extension of indications 17/06/10
Lapatinib Tykerb GlaxoSmithKline Australia Pty Ltd PM-2011-00908-3-4 Extension of indications 12/11/12
Ledipasvir / Sofosbuvir Harvoni Gilead Sciences Pty Ltd PM-2014-00469-1-2 New chemical entity 08/10/15
Lenalidomide Revlimid Celgene Pty Ltd PM-2014-02792-1-4 Extension of indications, New strength 05/02/16
Lenvatinib mesilate Lenvima Eisai Australia Pty Ltd PM-2014-04321-1-4 New chemical entity 30/08/16
Lesinurad Zurampic AstraZeneca Pty Ltd PM-2014-04708-1-3 New chemical entity 20/09/16
Leuprorelin acetate Lucrin Depot / Lucrin XL Depot Abbott Australasia Pty Ltd PM-2009-00544-3-4 New strength, New route of administration 30/07/10
Levomilnacipran (as hydrochloride) Fetzima Pierre Fabre Australia Pty Ltd PM-2014-04276-1-1 New chemical entity 13/12/16
Levonorgestrel Jaydess Bayer Australia Limited PM-2012-01933-3-5 Major variation (new strength, new indication, modified deliver system) 05/02/14
Levonorgestrel / ethinyloestradiol Seasonique Teva Pharma Australia Pty Ltd PM-2015-00767-1-5 Major variation (change in dosage amount and regimen) 09/12/16
Linagliptin Trajenta Boehringer Ingelheim Pty Limited PM-2012-01168-3-5 Extension of indications 26/09/13
Linagliptin Trajenta Boehringer Ingleheim (Australia) Pty Ltd PM-2010-02400-3-5 New chemical entity 12/12/11
Linagliptin / Metformin HCl Trajentamet Boehringer Ingelheim Pty Limited PM-2011-03536-3-5 New fixed combination 26/09/13
Lipegfilgrastim (rbe) Lonquex Teva Pharma Australia Pty Ltd PM- 2014-03142-1-4 New chemical entity 23/02/16
Lipids, Amino acids and Glucose, with and without Electrolytes Olimel N5-860E, Olimel N7-960, Olimel N7-960E, Olimel N9-840,Olimel N9-840E, PeriOlimel N4-600E Baxter Healthcare Pty Ltd PM-2012-00805-3-1 New fixed combination 02/10/13
Liraglutide Saxenda Novo Nordisk Pharmaceuticals Pty Ltd PM-2014-01472-1-5 Extension of indications 23/03/16
Liraglutide (rys) Victoza Novo Nordisk Pharmaceuticals Pty Ltd PM-2008-2113-5 New biological entity 22/11/10
Lisdexamfetamine dimesilate Vyvanse Shire Australia Pty Ltd PM-2012-01494-3-1 New chemical entity 23/10/13
Lixisenatide 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 Sanofi-Aventis Australia Pty Ltd PM-2011-03163-3-5 New chemical entity 20/08/13
Loteprednol etabonate Lotemax Bausch & Lomb (Australia) Pty Ltd PM-2012-03141-1-5 New chemical entity 17/04/14
Lumacaftor / ivacaftor Orkambi 200/125 Vertex Pharmaceuticals Australia Pty Ltd PM-2015-00424-1-5 New chemical entity in a fixed dose combination 08/09/16
Lurasidone hydrochloride Latuda Commercial Eyes Pty Ltd PM-2012-04452-1-1 New chemical entity 20/06/14
Lutropin alfa (rch) / Follitropin alfa (rch) Pergoveris Merck Serono Australia Pty Ltd PM-2008-1439-5 New fixed combination 11/01/10

M

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Macitentan Opsumit Actelion Pharmaceuticals Australia Pty Ltd PM-2012-04112-1-3 New chemical entity 28/04/14
Mannitol Bronchitol Pharmaxis Ltd PM-2009-03748-3-5 Extension of indications 29/03/11
Maraviroc Celsentri ViiV Healthcare Pty Ltd PM-2010-02896-3-2 Major variation (extension of indications) 12/05/13
Medium chain triglycerides / Olive oil / Fish oil / Soya oil SMOFlipid Fresenius Kabi Australia Pty Ltd PM-2008-03674-3-1 New combination 10/06/10
Medroxyprogesterone acetate Sayana Pfizer Australia Pty Ltd PM-2009-03498-3-5 Major variation (route of administration) 27/07/11
Melatonin Circadin Commercial Eyes Pty Ltd PM-2008-2125-1 New chemical entity 28/11/09
Melatonin Circadin RAD Data Australia Pty Ltd PM-2010-01756-3-1 Extension of indications 18/01/11
Meningococcal (groups A,C,W-135,Y) polysaccharide tetanus toxoid conjugate vaccine Nimenrix GlaxoSmithKline Australia Pty Ltd PM-2012-01958-3-2 New chemical entity 04/12/13
Meningococcal conjugate vaccine Group C and Hib Menitorix GlaxoSmithKline Australia Pty Ltd PM-2009-00817-3-2 New biological entity (new combination vaccine) 02/08/10
Meningococcal conjugated vaccine Menveo Novartis Vaccines and Diagnostics Pty Ltd SM-2009-00001-3-2 New chemical entity 20/05/10
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine - Groups A, C, Y and W-135 Menactra Sanofi Pasteur Pty Ltd PM-2010-00277-3-5 New chemical entity 31/08/11
Mepolizumab (rch) Nucala GlaxoSmithKline Australia Pty Ltd PM-2014-03872-1-5 New biological entity 08/03/17
Metformin / Sitagliptin Janumet Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01226-3-5 Extension of indications 14/01/13
Metformin HCl / Linagliptin Trajentamet Boehringer Ingelheim Pty Limited PM-2011-03536-3-5 New fixed combination 26/09/13
Metformin hydrochloride (HCl) / Dapagliflozin (as propanediol monohydrate) Xigduo XR 10/500, Xigduo XR 10/1000, Xigduo XR 5/1000 AstraZeneca Pty Ltd PM-2013-01515-1-5 Fixed dose combination 17/12/14
Metformin hydrochloride / Saxagliptin Kombiglyze Bristol-Myers Squibb Australia Pty Ltd PM-2012-00296-3-5 New fixed dose combination 15/10/13
Metformin hydrochloride / Vildagliptin Galvumet / Sobrea Novartis Pharmaceuticals Australia Pty Limited PM-2009-00972-3-5 New fixed combination 07/12/10
MF59C.1 adjuvanted / Trivalent seasonal influenza vaccine, inactivated Fluad Paediatric Novartis Vaccines and Diagnostics Pty Ltd PM-2010-03905-3-2 New biological entity 04/10/12
Micafungin (as sodium) Mycamine Astellas Pharma Australia Pty Ltd PM-2011-04271-3-2 New chemical entity 09/08/13
Mifepristone Mifepristone Linepharma MS Health PM-2010-02694-3-5 New chemical entity 02/10/12
Mifepristone / misoprostol MS-2 Step MS Health Pty Ltd PM-2013-01037-1-5 New combination of active ingredients 13/10/14
Miglustat Zavesca Actelion Pharmaceuticals Australia Pty Ltd PM-2008-3187-1 Extension of indications 09/03/10
Milnacipran hydrochloride Joncia Pierre Fabre Medicament Australia Pty Ltd PM-2011-02708-3-1 New chemical entity 24/01/12
Mirabegron Betmiga Astellas Pharma Australia Pty Ltd PM-2012-01928-3-3 New chemical entity 09/01/14
Misoprostol GyMiso MS Health PM-2011-01625-3-5 Extension of indications 02/10/12
Misoprostol Misodel/ Misopess Ferring Pharmaceuticals Pty Ltd PM-2012-03740-1-5 Major variation (extension of indication, new dose form, new route of administration) 23/04/14
Misoprostol / mifepristone MS-2 Step MS Health Pty Ltd PM-2013-01037-1-5 New combination of active ingredients 13/10/14
Multi-Component Meningococcal B vaccine Bexsero Novartis Vaccines and Diagnostics Pty Ltd PM-2011-02486-3-2 New chemical entity 31/10/13
Mycophenolate sodium Myfortic Novartis Pharmaceuticals Australia Pty Limited PM-2010-01235-3-2 Major variation (extension of indications) 17/05/13

N

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Nabiximols Sativex Novartis Pharmaceuticals Australia Pty Limited PM-2011-00150-3-1 New chemical entity 27/09/13
Nalmefene (as hydrochloride dihydrate) Selincro Lundbeck Australia Pty Ltd PM-2013-02690-1-1 New chemical entity 09/08/16
Naloxegol oxalate Movantik AstraZeneca Pty Ltd PM-2014-03892-1-1 New chemical entity 01/06/16
Naloxone / Buprenorphine Suboxone Sublingual Film Reckitt Benckiser (Australia) Pty Ltd PM-2009-01902-3-1 New dose form 07/12/10
Naloxone hydrochloride / Oxycodone hydrochloride Targin Mundipharma Pty Ltd PM-2008-2938-1 New fixed combination 04/05/10
Nanoparticle albumin-bound (nab) paclitaxel Abraxane Abraxis BioScience Australia Pty Ltd PM-2012-01185-3-4 Extension of indications 09/01/14
Nanoparticle albumin-bound (nab) paclitaxel Abraxane Abraxis BioScience Australia Pty Ltd PM-2013-01523-1-4 Extension of indications 17/06/14
Naproxen / Esomeprazole Vimovo AstraZeneca Pty Ltd PM 2010-00846-3-3 New fixed combination 09/11/11
Nepafenac Ilevro Alcon Laboratories (Australia) Pty Ltd PM-2014-00379-1-2 New chemical entity 23/12/15
Netupitant / Palonosetron (as hydrochloride) Akynzeo Specialised Therapeutics Australia Pty Ltd PM-2014-00341-1-4 New chemical entity, New fixed dose combination 28/10/16
Nevirapine Viramune XR Boehringer Ingelheim Pty Limited PM-2010-03093-3-2 New dosage form 19/03/12
Nilotinib Tasigna Novartis Pharmaceuticals Australia Pty Limited PM-2010-01053-3-4 Extension of indications, New strength 04/10/11
Nine trace elements including chromic chloride Addaven Fresenius Kabi Australia Pty Ltd PM-2015-01467-1-1 New chemical entity 23/03/17
Nintedanib esilate Ofev / Vargatef Boehringer Ingelheim Pty Ltd PM-2014-01847-1-4 New chemical entity 08/02/16
Nintedanib esilate Vargatef / Ofev Boehringer Ingelheim Pty Ltd PM-2014-01847-1-4 New chemical entity 08/02/16
Nitisinone Orfadin Orphan Australia Pty Ltd PM-2009-02266-3-3 New chemical entity 15/10/10
Nivolumab Opdivo Bristol-Myers Squibb Australia Pty Ltd PM-2014-03852-1-4 New chemical entity 23/08/16
Nomegestrol acetate / Oestradiol Zoely Merck Sharp & Dohme (Australia) Pty Ltd PM-2010-00254-3-5 New chemical entity 04/10/11
Nonacog gamma Rixubis Baxter Healthcare Pty Ltd PM-2012-03758-1-4 New biological entity 14/04/14
Norethisterone acetate / Oestradiol Kliovance Low Novo Nordisk Pharmaceuticals Pty Ltd PM-2010-00087-5-3 New strength 18/01/12
Normal human immunoglobulin Hizentra CSL Behring Ltd PM-2013-00301-2-2 New biological entity 25/06/14

O

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Obinutuzumab Gazyva Roche Products Pty Ltd PM-2013-01148-1-4 New biological entity 26/08/14
Ocriplasmin Jetrea Alcon Laboratories Australia Pty Ltd PM-2012-04123-1-5 New biological entity 10/11/14
Octreotide Sandostatin LAR Novartis Pharmaceuticals Australia Pty Limited PM-2010-03092-3-4 Extension of indications 14/02/12
Oestradiol / Nomegestrol acetate Zoely Merck Sharp & Dohme (Australia) Pty Ltd PM-2010-00254-3-5 New chemical entity 04/10/11
Oestradiol / Norethisterone acetate Kliovance Low Novo Nordisk Pharmaceuticals Pty Ltd PM-2010-00087-5-3 New strength 18/01/12
Oestradiol valerate / Dienogest Qlaira Bayer Australia Limited PM-2009-02910-3-5 Extension of indications 28/03/11
Ofatumumab Arzerra GlaxoSmithKline Australia Pty Ltd PM-2009-02159-3-4 New biological entity 15/12/10
Olive oil / Fish oil / Soya oil / Medium chain triglycerides SMOFlipid Fresenius Kabi Australia Pty Ltd PM-2008-03674-3-1 New combination 10/06/10
Olmesartan medoxomil Olmetec Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01941-3-3 Major variation (new dosage form, increase in patient group) 26/02/13
Olmesartan medoxomil / Amlodipine (as besilate) / Hydrochlorothiazide Sevikar HCT Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-01550-3-3 New fixed dose combination 18/11/13
Olmesartan medoxomil / Amlodipine besylate Sevikar Schering-Plough Pty Ltd PM-2008-03320-3-3 New fixed dose combination 21/09/10
Olodaterol (as hydrochloride) Striverdi Respimat Boehringer Ingelheim Pty Limited PM-2012-01920-3-5 New chemical entity 27/03/14
Omalizumab (rch) Xolair Novartis Pharmaceuticals Pty Ltd PM-2013-03254-1-4 Major variation (extension of indications) 21/07/15
Omalizumab (rch) Xolair Novartis Australia Pty Ltd PM-2014-03868-1-5 Extension of indications 22/06/16
Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir (as sodium salt) Viekira Pak AbbVie Pty Ltd PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir (as sodium salt) and Ribavirin Viekira Pak-RBV AbbVie Pty Ltd PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
Omega-3-acid ethyl esters 90 Omacor Abbott Products Pty Ltd PM-2008-3043-3 New chemical entity 28/07/10
Oseltamivir phosphate Tamiflu Roche Products Pty Ltd PM-2010-00616-3-2 Major variation (extension of indications/new population) 27/07/11
Oxaliplatin / Capecitabine Eloxatin / Oxaliplatin Dakota / Winthrop Oxaliplatin / Xeloda Sanofi-Aventis Australia Pty Ltd/Roche Products Pty Ltd PM-2010-00909-4/ 2010-02795-4 Major variation (extension of indications, new dosage) 23/03/11
Oxaliplatin / Capecitabine Oxaliplatin Dakota / Eloxatin / Winthrop Oxaliplatin / Xeloda Sanofi-Aventis Australia Pty Ltd/Roche Products Pty Ltd PM-2010-00909-4/ 2010-02795-4 Major variation (extension of indications, new dosage) 23/03/11
Oxaliplatin / Capecitabine Winthrop Oxaliplatin / Eloxatin / Oxaliplatin Dakota / Xeloda Sanofi-Aventis Australia Pty Ltd/Roche Products Pty Ltd PM-2010-00909-4/ 2010-02795-4 Major variation (extension of indications, new dosage) 23/03/11
Oxycodone hydrochloride / Naloxone hydrochloride Targin Mundipharma Pty Ltd PM-2008-2938-1 New fixed combination 04/05/10

P

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Paliperidone Invega Janssen-Cilag Pty Ltd PM-2009-00515-3-1 Extension of indications 14/12/09
Paliperidone Invega Janssen-Cilag Pty Ltd PM-2011-02378-3-1 Extension of indications 20/05/13
Paliperidone palmitate Invega Sustenna Janssen-Cilag Pty Ltd PM-2009-00926-3-1 New salt of a previously approved active ingredient 20/07/10
Palonosetron (as hydrochloride) / Netupitant Akynzeo Specialised Therapeutics Australia Pty Ltd PM-2014-00341-1-4 New chemical entity, New fixed dose combination 28/10/16
Palonosetron hydrochloride Aloxi Specialised Therapeutics Australia Pty Ltd PM-2012-02735-3-4 Major variation (dosage) 07/01/14
Pancreatic extract Creon Micro Abbott Products Pty Ltd PM-2009-02729-3-1 New formulation 28/09/10
Pandemic influenza vaccine Pandemic Influenza Vaccine H5N1 Baxter Baxter Healthcare Pty Ltd PM-2008-1961-2 New biological entity 09/12/10
Pandemic influenza vaccine Arepanrix H5N1 GSK Australia Pty Ltd PM-2009-03131-3-2 New biological entity 01/02/11
Pandemrix Pandemic H1N1 influenza vaccine GlaxoSmithKline Australia Pty Ltd PM-2009-03526-3-2 Major variation 20/10/10
Panitumumab Vectibix Amgen Australia Pty Ltd PM-2010-01972-3-4 Major variation (extension of indications) 07/05/12
Paracetamol / Tramadol hydrochloride Zaldiar Grunenthal Pty Ltd PM-2010-3272-3-1 New fixed combination 13/09/12
Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) Viekira Pak AbbVie Pty Ltd PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin Viekira Pak-RBV AbbVie Pty Ltd PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
Pasireotide (as diaspartate) Signifor Novartis Pharmaceuticals Australia Pty Limited PM-2014-02743-3-5 New chemical entity 27/03/14
Pazopanib hydrochloride Votrient GlaxoSmithKline Australia Pty Ltd PM-2009-01084-4 New chemical entity 01/09/10
Pazopanib hydrochloride Votrient GlaxoSmithKline Australia Pty Ltd PM-2011-01972-3-4 Extension of indications 25/02/13
Peginterferon alfa-2a / Ribavirin Copegus / Pegasys RBV / Pegasys Roche Australia Pty Ltd PM-2010-00382/00415/00416-3-2 Major variation 15/06/11
Peginterferon alfa-2a / Ribavirin Pegasys RBV / Pegasys / Copegus Roche Australia Pty Ltd PM-2010-00382/00415/00416-3-2 Major variation 15/06/11
Peginterferon beta 1a (rch) Plegridy Biogen Idec Australia Pty Ltd PM-2013-02425-1-1 Biological medicine 05/02/15
Pembrolizumab (rch) Keytruda Merck Sharp & Dohme (Australia) Pty Ltd PM-2014-01928-1-4 New biological chemical entity 14/10/16
Perampanel (as hemisesquihydrate) Fycompa Eisai Australia Pty Ltd/Commercial Eyes Pty Ltd PM-2013-00324-1-1 New chemical entity 14/10/14
Perindopril arginine / Amlodipine (as besylate) Coveram Servier Laboratories (Aust) Pty Ltd PM-2008-2262-3 New combination 13/11/09
Pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide / Hepatitis B surface antigen Hexaxim Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Pertuzumab Perjeta Roche Products Pty Limited PM-2014-04259-1-4 Extension of indications 16/06/16
Pertuzumab (rch) Perjeta Roche Products Pty Ltd PM-2012-00311-3-4 New biological entity 01/10/13
Pirfenidone Esbriet Roche Products Pty Ltd PM-2015-00413-1-5 New chemical entity 09/08/16
Pitavastatin Livalo Abbott Australasia Pty Ltd PM-2010-02898-3-3 New chemical entity 02/09/13
Plerixafor Mozobil Genzyme Australasia Pty Ltd SM-2008-03602-4 New chemical entity 23/07/10
Pneumococcal Polysaccharide Conjugate Vaccine Prevenar 13 Wyeth Australia Pty Ltd PM-2009-00110-3-2 New biological entity 13/05/10
Pneumococcal Polysaccharide Conjugate Vaccine 13 valent Prevenar 13 Pfizer Australia Pty Ltd PM-2010-03262-3-2 Extension of indications, Changes to Product Information 13/12/11
Pneumococcal polysaccharide conjugate vaccine, 10-valent adsorbed Synflorix GlaxoSmithKline Australia Pty Ltd PM-2010-02793-3-2 Major variation (extension of indications) 22/10/12
Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed Prevenar 13 Pfizer Australia Pty Ltd PM-2013-01480-1-3 Extension of indications 17/09/14
Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed Prevenar 13 Pfizer Australia Pty Ltd PM-2012-02211-3-2 Extension of indications, Changes to Product Information 07/02/14
Poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide / Hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid Hexaxim Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Pomalidomide Pomalyst Celgene Australia Pty Ltd PM-2013-02037-1-4 New chemical entity 13/10/14
Ponatinib Iclusig ARIAD Pharmaceuticals Australia Pty Ltd PM-2013-02061-1-4 New chemical entity 16/04/15
Pralatrexate Folotyn Mundipharma Pty Ltd PM-2011-03153-3-4 New chemical entity 22/08/13
Prednisone Lodotra Mundipharma Pty Ltd PM 2011-00520-3-3 Major variation (new dosage form) 13/06/13
Progesterone Endometrin Pessaries Ferring Pharmaceuticals Pty Ltd PM-2011-02023-3-5 Major variation (new strength) 12/06/13
Propranolol hydrochloride Hemangiol 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
Prucalopride Resotrans Janssen-Cilag Pty Ltd PM-2010-03060-3-1 New chemical entity 23/11/11
Purified antigen fractions of inactivated split virion A/Indonesia/05/2005 (H5N1) AS03 adjuvanted Prepandrix GlaxoSmithKline Australia Pty Ltd PM‐2013‐04610‐1‐2 New biological entity 23/12/15

Q

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Quetiapine (as fumarate) Seroquel, Seroquel XR AstraZeneca Pty Ltd PM-2008-03436-1 Extension of indications 13/04/10

R

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Radium (223Ra) dichloride Xofigo Bayer Australia Limited PM-2013-00738-1-2 New chemical entity 10/07/14
Raltegravir Isentress Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-03107-3-2 New dosage form 03/06/13
Ranibizumab Lucentis Novartis Pharmaceuticals Australia Pty Limited PM-2010-02527-3-5 Extension of indications 09/11/11
Ranibizumab Lucentis Novartis Pharmaceuticals Australia Pty Limited PM-2010-03258-3-5 Extension of indications, Changes to Product Information 01/12/11
Ranibizumab Lucentis Novartis Pharmaceuticals Australia Pty Ltd PM-2013-00985-1-5 Extension of indications 14/10/14
Rasagiline Azilect Lundbeck Australia Pty Ltd PM-2010-00798-3-1 New chemical entity 08/02/12
Regorafenib Stivarga Bayer Australia Ltd PM-2013-04954-1-4 Extension of indications 19/11/15
Regorafenib Stivarga Bayer Australia Limited PM-2012-02342-3-4 New chemical entity 07/02/14
Remestemcel-L ex vivo adult human mesenchymal stem cells Prochymal Delpharm Consultants Pty Limited PM-2011-01529-3-2 New biological entity 05/03/15
Remifentanil (as hydrochloride) Ultiva GlaxoSmithKline Australia Pty Ltd PM-2011-00909-3-1 Major variation (new mode of administration) 29/01/13
Retapamulin Altargo GlaxoSmithKline Australia Pty Ltd PM-2012-01489-3-2 New chemical entity 11/11/13
Retigabine Trobalt GlaxoSmithKline Australia Pty Ltd PM-2011-04248-3-1 New chemical entity 17/10/13
Ribavirin / Peginterferon alfa-2a Pegasys RBV / Pegasys / Copegus Roche Australia Pty Ltd PM-2010-00382/00415/00416-3-2 Major variation 15/06/11
Ribavirin and Dasabuvir (as sodium salt) and Paritaprevir / Ritonavir / Ombitasvir Viekira Pak-RBV AbbVie Pty Ltd PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
Rifaximin Xifaxan Norgine Pty Ltd PM-2014-00379-1-2 Extension of indications 13/10/15
Rifaximin Xifaxan Norgine Pty Ltd PM-2011-00501-3-1 New chemical entity 19/11/12
Rilpivirine Edurant Janssen-Cilag Pty Ltd PM-2010-03030-3-2 New chemical entity 27/03/12
Rilpivirine / Tenofovir disoproxil fumarate / emtricitabine Eviplera Gilead Sciences Pty Ltd PM-2010-02853-3-2 New chemical entity 27/03/12
Rilpivirine / Tenofovir disoproxil fumarate / emtricitabine Eviplera Gilead Sciences Pty Ltd M-2013-01524-1-2 Extension of indications 15/07/14
Riociguat Adempas Bayer Australia Limited PM-2013-00307-1-3 New chemical entity 12/06/14
Risperidone Risperdal Consta Janssen-Cilag Pty Ltd PM-2008-03495-3-1 Extension of indications 18/06/10
Ritonavir / Ombitasvir / Paritaprevir and Dasabuvir (as sodium salt) Viekira Pak AbbVie Pty Ltd PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
Ritonavir / Paritaprevir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin Viekira Pak-RBV AbbVie Pty Ltd PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
Rituximab MabThera Roche Products Pty Ltd PM-2009-01744-3-3 Extension of indications, Broaden patient population 06/05/10
Rituximab MabThera Roche Products Pty Ltd PM-2010-01845-3-4 New dosage regimen 09/12/11
Rituximab MabThera Roche Products Pty Ltd PM-2012-00331-3-3 Extension of indications 13/08/13
Rituximab MabThera Roche Products Pty Ltd PM-2013-04906-1-3 New dosing schedule 27/08/15
Rituximab MabThera SC Roche Products Pty Limited PM-2012-04453-1-4 New dose form 04/09/14
Rituximab MabThera Roche Products Pty Ltd PM-2014-04709-1-4 Major variation 09/02/17
Rituximab MabThera Roche Products Pty Ltd PM-2009-00656-3-4 Extension of indications 19/02/10
Rivaroxaban Xarelto Bayer Australia Limited PM-2010-03901-3-3 Extension of indications 13/09/12
Rivaroxaban Xarelto Bayer Australia Limited PM-2012-01179-3-3 Extension of indications 02/10/13
Rivaroxaban Xarelto Bayer Australia Limited PM-2011-03916-3-3 Extension of indications, New strength 11/11/13
Roflumilast Dalveza / Daxas / Xevex Nycomed Pty Ltd PM-2009-02915-3-5 New chemical entity 20/12/11
Roflumilast Daxas / Xevex / Dalveza Nycomed Pty Ltd PM-2009-02915-3-5 New chemical entity 20/12/11
Roflumilast Xevex / Daxas / Dalveza Nycomed Pty Ltd PM-2009-02915-3-5 New chemical entity 20/12/11
Romidepsin Istodax Celgene Australia Pty Ltd PM-2012-01446-3-4 New chemical entity 20/11/13
Ropivacaine Naropin AstraZeneca Pty Ltd PM-2009-01406-3-1 Extension of indications 23/04/10
Rosuvastatin Crestor / Visacor AstraZeneca Pty Ltd PM-2009-01470-3-3 Extension of indications 25/05/11
Rosuvastatin Visacor / Crestor AstraZeneca Pty Ltd PM-2009-01470-3-3 Extension of indications 25/05/11
Rosuvastatin (as calcium) / Ezetimibe Ezalo, Rosuzet Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-02434-1-3 New fixed dose combination 29/01/15
Rosuvastatin (as calcium) / Ezetimibe Rosuzet, Ezalo Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-02434-1-3 New fixed dose combination 29/01/15
Rosuvastatin (as calcium) and ezetimibe Rosuzet Composite Pack / Ezalo Composite Pack Merck Sharp & Dohme (Australia) Pty Ltd PM-2012-03419-1-3 New combination of active ingredients 05/03/14
Rotigotine Neupro UCB Australia Pty Ltd PM-2009-01999-3-1 Extension of indications, New strength 08/10/10
Rupatadine Rupafin iNova Pharmaceuticals (Australia) Pty Ltd PM-2009-03232-3-5 New chemical entity 18/05/11
Ruxolitinib Jakavi Novartis Australia Pty Ltd PM-2012-01504-3-4 New chemical entity 21/01/14

S

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Sacubitril / Valsartan salt complex Entresto / Novartis sacubitril/valsartan Novartis Pharmaceuticals Australia Pty Ltd PM-2015-00001-1-3 New combination product 23/09/16
Sapropterin dihydrochloride Kuvan Merck Serono Australia Pty Ltd PM-2009-02891-3-3 New chemical entity 21/10/10
Saxagliptin Onglyza Bristol-Myers Squibb / AstraZeneca PM-2010-03800-3-5 Major variation (new strength, new patient group, change in dosage) 25/06/12
Saxagliptin (as hydrochloride) Onglyza Bristol-Myers Squibb Australia Pty Ltd PM-2011-01174-3-5 Extension of indications 13/03/13
Saxagliptin / Metformin hydrochloride Kombiglyze Bristol-Myers Squibb Australia Pty Ltd PM-2012-00296-3-5 New fixed dose combination 15/10/13
Saxagliptin hydrochloride Onglyza Bristol-Myers Squibb Australia Pty Ltd PM-2008-03469-3-5 New chemical entity 13/04/11
Secukinumab Cosentyx / Zafrez Novartis Pharmaceuticals Australia Pty Ltd PM-2015-00766-1-3 / 2015-00777-1-3 Extension of indications 25/10/16
Secukinumab Cosentyx / Zafrez Novartis Pharmaceutical Australia Pty Ltd PM-2013-04153-1-4 New chemical entity 16/09/15
Secukinumab Zafrez / Cosentyx Novartis Pharmaceuticals Australia Pty Ltd PM-2015-00766-1-3 / 2015-00777-1-3 Extension of indications 25/10/16
Secukinumab Zafrez / Cosentyx Novartis Pharmaceutical Australia Pty Ltd PM-2013-04153-1-4 New chemical entity 16/09/15
Selexipag Uptravi Actelion Pharmaceuticals Pty Ltd PM-2014-04586-1-3 New chemical entity 08/11/16
Sevelamer carbonate Renvela / Sevelamer Carbonate Winthrop / Sevelamer Carbonate Sanofi Sanofi-Aventis Australia Pty Ltd PM-2013-04961-1-3 New chemical entity 02/10/15
Sevelamer carbonate Sevelamer Carbonate Winthrop / Sevelamer Carbonate Sanofi / Renvela Sanofi-Aventis Australia Pty Ltd PM-2013-04961-1-3 New chemical entity 02/10/15
Sevelamer hydrochloride Chemmart Sevelamer / Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / GenRx Sevelamer / Terry White Chemists Sevelamer Generic Partners PM-2013-00742-1-3 New generic 05/11/15
Sevelamer hydrochloride GenRx Sevelamer / Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / Terry White Chemists Sevelame Generic Partners PM-2013-00742-1-3 New generic 05/11/15
Sevelamer hydrochloride Terry White Chemists Sevelame / Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / GenRx Sevelamer Generic Partners PM-2013-00742-1-3 New generic 05/11/15
Sevelamer hydrochloride Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / GenRx Sevelamer / Terry White Chemists Sevelamer Generic Partners PM-2013-00742-1-3 New generic 05/11/15
Sevelamer hydrochloride Phosligand / Sevelamer GPPL / Sevelamer GxP / Seveligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / GenRx Sevelamer / Terry White Chemists Sevelame Generic Partners PM-2013-00742-1-3 New generic 05/11/15
Sildenafil Revatio Pfizer Australia Pty Ltd PM-2010-00912-3-3 Extension of indications, Major variation 12/10/11
Sildenafil Revatio Pfizer Australia Pty Ltd PM-2010-00820-3-3 Extension of indications 19/10/11
Simeprevir (as sodium) Janssen Simeprevir / Olysio Janssen-Cilag Pty Ltd PM-2013-01557-1-2 New chemical entity 27/10/14
Simeprevir (as sodium) Olysio / Janssen Simeprevir Janssen-Cilag Pty Ltd PM-2013-01557-1-2 New chemical entity 27/10/14
Simoctocog alfa rhu Nuwiq Octapharma Australia Pty Ltd PM-2013-02226-1-4 New biological entity 07/06/16
Simvastatin / Ezetimibe Vytorin Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01219-3-1 Extension of indications 28/02/13
Sitagliptin (as phosphate monohydrate) Januvia MSD (Australia) Pty Limited PM 2011-01224-3-5 Extension of indications 20/12/12
Sitagliptin / Metformin Janumet Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-01226-3-5 Extension of indications 14/01/13
Sitagliptin / Simvastatin Juvicor / Xelezor / Tesozor Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-02796-3-5 New fixed combination 06/06/13
Sitagliptin / Simvastatin Tesozor / Juvicor / Xelezor Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-02796-3-5 New fixed combination 06/06/13
Sitagliptin / Simvastatin Xelezor / Tesozor / Juvicor Merck Sharp & Dohme (Australia) Pty Ltd PM-2011-02796-3-5 New fixed combination 06/06/13
SMOFlipid 20% / Aminoven 10% (with or without electrolytes) / glucose 42% SmofKabiven / SmofKabiven Electrolyte Free Emulsion Fresenius Kabi Australia Pty Ltd PM-2010-02110-3-1 New fixed combination 15/03/12
Sofosbuvir Sovaldi Gilead Sciences Pty Ltd PM-2013-01283-1-2 New chemical entity 05/08/14
Sofosbuvir / Ledipasvir Harvoni Gilead Sciences Pty Ltd PM-2014-00469-1-2 New chemical entity 08/10/15
Somatropin Genotropin Pfizer Australia Pty Ltd PM-2008-2730-5 Product information change 09/03/10
Somatropin Zomacton Ferring Pharmaceuticals Pty Ltd PM-2008-2954-5 Major variation (new strength, new mode of administration) 01/12/10
Somatropin Humatrope Eli Lilly Australia Pty Ltd PM-2010-00615-3-5 Extension of indications 15/01/13
Sorafenib Nexavar Bayer Australia Ltd PM-2013-02057-1-4 Extension of indications, Changes to Product Information 06/08/14
Soya oil / Medium chain triglycerides / Olive oil / Fish oil SMOFlipid Fresenius Kabi Australia Pty Ltd PM-2008-03674-3-1 New combination 10/06/10
Split virus / Vero cell derived / Inactivated influenza vaccine Preflucel Baxter Healthcare Pty Ltd PM-2010-03274-3-2 New biological entity 06/07/12
Strontium ranelate Protos Servier Laboratories (Aust) Pty Ltd PM-2011-00498-3-5 Extension of indications 07/01/13
Sucroferric oxyhydroxide Velphoro Vifor Pharma Pty Ltd PM-2013-03249-1-3 New chemical entity 19/02/15
Sunitinib Sutent Pfizer Australia Pty Ltd PM-2010-01205-4 Extension of indications, New dosage 29/06/11
Suvorexant Belsomra Merck Sharp and Dohme Australia Pty Ltd PM-2013-00325-1-1 New chemical entity 11/03/15

T

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Tacrolimus Prograf-XL Janssen-Cilag Pty Ltd PM-2008-03783-3-2 New dosage form 06/05/10
Tadalafil Adcirca Eli Lilly Australia Pty Ltd PM-2010-01829-3-3 Extension of indications, Additional trade name 20/09/11
Tadalafil Cialis Eli Lilly Australia Pty Ltd PM-2011-03166-3-3 Extension of indications 22/07/13
Tafluprost Saflutan Merck Sharp & Dohme (Australia) Pty Ltd PM-2009-3896-5 New chemical entity 03/05/12
Tafluprost/Timolol Taptiqom 15/5 Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-03652-1-5 New fixed dose combination 28/07/15
Taliglucerase alfa rpc Elelyso Pfizer Australia Pty Ltd PM-2013-00303-1-3 New biological entity 14/10/14
Talimogene laherparepvec Imlygic Amgen Australia Pty Ltd PM-2014-03464-1-4 New biological entity 31/05/16
Tamsulosin / Dutasteride Duodart GlaxoSmithKline Australia Pty Ltd PM-2009-01559-3-3 New fixed dose combination 20/10/10
Tapentadol Palexia IR CSL Limited PM-2009-02488-3-1 New chemical entity 17/11/10
Tapentadol Palexia SR CSL Limited PM-2009-02489-3-1 New chemical entity 28/02/11
Tazobactam (as sodium salt) / Ceftolozane (as sulfate) Zerbaxa Merck Sharp & Dohme Australia Pty Ltd PM-2014-03153-1-2 New chemical entity 27/01/16
Telaprevir Incivo Janssen-Cilag Pty Ltd PM-2010-03576-3-2 New chemical entity 26/10/12
Telmisartan Micardis / Pritor Boehringer Ingelheim Pty Limited PM-2009-00165-3-3 Extension of indications 22/04/10
Telmisartan Pritor / Micardis Boehringer Ingelheim Pty Limited PM-2009-00165-3-3 Extension of indications 22/04/10
Telmisartan / Amlodipine Twynsta Boehringer Ingelheim Pty Limited PM-2009-03138-3-3 New fixed dose combination 14/02/11
Tenofovir alafenamide (as fumarate) / Elvitegravir / Cobicistat / Emtricitabine Genvoya Gilead Sciences Pty Ltd PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Tenofovir alafenamide (as fumarate) / Emtricitabine Descovy Gilead Sciences Pty Ltd PM-2015-01283-1-3 New fixed dose combination 20/12/16
Tenofovir disoproxil fumarate Viread Gilead Sciences Pty Ltd PM-2012-01178-3-2 Extension of indications 14/10/13
Tenofovir disoproxil fumarate / Emtricitabine Truvada Gilead Sciences Pty Ltd PM-2015-00411-1-2 Extension of indications 10/11/16
Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir / Cobicistat Stribild Gilead Sciences Pty Ltd PM-2011-03533-3-2 New fixed dose combination 05/08/13
Tenofovir disoproxil fumarate / emtricitabine / rilpivirine Eviplera Gilead Sciences Pty Ltd PM-2010-02853-3-2 New chemical entity 27/03/12
Tenofovir disoproxil fumarate / emtricitabine / rilpivirine Eviplera Gilead Sciences Pty Ltd PM-2013-01524-1-2 Extension of indications 15/07/14
Teriflunomide Teriflunomide Winthrop / Aubagio / Teriflunomide Sanofi Sanofi-Aventis Australia Pty Ltd PM-2011-02772-3-1 New chemical entity 21/05/13
Teriflunomide Aubagio / Teriflunomide Winthrop / Teriflunomide Sanofi Sanofi-Aventis Australia Pty Ltd PM-2011-02772-3-1 New chemical entity 21/05/13
Teriflunomide Teriflunomide Sanofi / Aubagio / Teriflunomide Winthrop Sanofi-Aventis Australia Pty Ltd PM-2011-02772-3-1 New chemical entity 21/05/13
Teriparatide Forteo Eli Lilly Australia Pty Ltd PM-2009-02138-3-5 Major variation (extension of treatment duration) 07/09/10
Terlipressin Lucassin Ikaria Australia Pty Ltd PM-2010-02975-3-1 New chemical entity 27/08/13
Terlipressin acetate Glypressin Ferring Pharmaceuticals Pty Ltd PM-2010-03182-3-3 New chemical entity 26/11/12
Tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide / Hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus Hexaxim Sanofi Aventis Australia Pty Ltd PM-2013-02800-1-2 New biological entity 12/01/15
Thyroxine sodium Thyroxine Aspen, Aspen Thyroxine, Eltroxin Aspen Pharma Pty Ltd PM-2012-04477-1-5 New generic, New strength 12/06/14
Thyroxine sodium Aspen Thyroxine, Eltroxin, Thyroxine Aspen Aspen Pharma Pty Ltd PM-2012-04477-1-5 New generic, New strength 12/06/14
Thyroxine sodium Eltroxin, Aspen Thyroxine, Thyroxine Aspen Aspen Pharma Pty Ltd PM-2012-04477-1-5 New generic, New strength 12/06/14
Ticagrelor Brilinta AstraZeneca Pty Ltd PM-2009-03523-3-3 New chemical entity 12/07/11
Timolol Maleate / Brinzolamide Azarga Alcon Laboratories (Australia) Pty Ltd PM-2008-3124-5 New fixed combination 19/02/10
Timolol/Tafluprost Taptiqom 15/5 Merck Sharp & Dohme (Australia) Pty Ltd PM-2013-03652-1-5 New fixed dose combination 28/07/15
Tiotropium bromide Spiriva Respimat / Favint Respimat Boehringer Ingelheim Pty Limited PM-2014-00350-1-5 Extension of indications 25/11/16
Tobramycin inhalation powder TOBI Podhaler Novartis Pharmaceuticals Australia Pty Limited PM-2011-00135-3-2 New dosage form 26/10/12
Tocilizumab Actemra Roche Products Pty Ltd PM-2009-03295-3-3 Extension of indications 13/01/11
Tocilizumab Actemra Roche Products Pty Ltd PM-2010-03070-3-3 Extension of indications 06/12/11
Tocilizumab Actemra Roche Products Pty Ltd PM-2012-01905-3-3 Extension of indications 06/02/14
Tocilizumab (rch) Actemra Roche Products Pty Ltd PM-2013-02398-1-3 Major variation (extension of indications) 13/01/15
Tocilizumab (rch) Actemra 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
Tofacitinib (as citrate) Xeljanz Pfizer Australia Pty Ltd PM-2012-00788-3-3 New chemical entity 06/03/15
Tolvaptan Samsca Orphan Australia Pty Ltd PM-2010-02939-3-5 New chemical entity 04/10/12
Trabectedin Yondelis Janssen-Cilag Pty Ltd PM-2009-01976-3-4 New chemical entity 09/11/10
Tramadol hydrochloride / Paracetamol Zaldiar Grunenthal Pty Ltd PM-2010-3272-3-1 New fixed combination 13/09/12
Trametinib (as dimethyl sulfoxide) Mekinist GlaxoSmithKline Australia Pty Ltd PM-2012-04134-1-4 New chemical entity 17/03/14
Tranexamic acid Cyklokapron Pfizer Australia Pty Ltd PM-2009-00587 Extension of indications, New dosage form 10/09/10
Trastuzumab Herceptin Roche Products Pty Ltd PM-2009-03121 Major variation (extension of indications) 17/09/10
Trastuzumab Herceptin Roche Products Pty Ltd 2011-01528-3-4 Extension of indications 17/12/12
Trastuzumab Herceptin Roche Products Pty Ltd PM-2013-04600-1-4 New route of administration 03/08/15
Trastuzumab emtansine Kadcyla Roche Products Pty Ltd PM-2012-02734-3-4 New chemical entity 17/03/14
Triptorelin acetate Decapeptyl Ferring Pharmaceuticals Pty Ltd PM-2013-04578-1-5 New chemical entity 24/08/15
Trivalent seasonal influenza vaccine, inactivated / MF59C.1 adjuvanted Fluad Paediatric Novartis Vaccines and Diagnostics Pty Ltd PM-2010-03905-3-2 New biological entity 04/10/12
Turoctocog alfa (rch) NovoEight Novo Nordisk Pharmaceuticals Pty Ltd PM-2012-03754-1-4 New chemical entity 07/05/14

U

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Ulipristal acetate EllaOne ERA Consulting (Australia) Pty Ltd PM-2013-04154-1-5 New chemical entity 04/09/15
Ulipristal acetate Esmya Vifor Pharma Pty Ltd PM-2015-00776-1-5 Extension of indications 19/10/16
Umeclidinium bromide Incruse Ellipta GlaxoSmithKline Australia Pty Ltd PM-2013-01505-1-5 New chemical entity 09/07/15
Umeclidinium bromide and Vilanterol trifenatate Anoro Ellipta GlaxoSmithKline Australia Pty Ltd PM-2013-00332-1-5 New fixed dose combination 08/04/15
Ursodeoxycholic acid Urso / Ursofalk Orphan Australia Pty Ltd PM-2008-03582-3-1 Extension of indications, Change of dosage 28/07/10
Ustekinumab Stelara Janssen-Cilag Pty Ltd PM-2013-04148-1-3 Extension of indications 09/07/15

V

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Valganciclovir Valcyte Roche Products Pty Ltd PM-2014-01870-1-2 Major variation (dosage) 05/01/16
Valsartan / Amlodipine Exforge/Ejocia 10/320; Exforge/Ejocia 5/320 Novartis Pharmaceuticals Australia Pty Limited PM-2009-01168-3-3 Major variation (new strength) 26/07/10
Valsartan / Amlodipine (as besylate) / Hydrochlorothiazide Exforge HCT / Ejocia HCT Novartis Pharmaceuticals Australia Pty Limited PM-2008-03499-3-3 New fixed combination 26/08/10
Valsartan salt complex / Sacubitril Entresto / Novartis sacubitril/valsartan Novartis Pharmaceuticals Australia Pty Ltd PM-2015-00001-1-3 New combination product 23/09/16
Vandetanib Caprelsa AstraZeneca Pty Ltd PM-2011-03002-3-4 New chemical entity 07/08/13
Vardenafil Levitra Bayer Australia Limited PM-2009-02689-3-3 New dosage form, Change in dosage instructions 12/01/11
Vedolizumab (rch) Entyvio / Kynteles Takeda Pharmaceuticals Australia Pty Ltd PM-2013-01102-1-1 New biological entity 17/11/14
Vedolizumab (rch) Kynteles / Entyvio Takeda Pharmaceuticals Australia Pty Ltd PM-2013-01102-1-1 New biological entity 17/11/14
Velaglucerase alfa (ghu) VPRIV Shire Australia Pty Ltd PM-2010-03810-3-3 New chemical entity (biological) 07/05/12
Vemurafenib Zelboraf Roche Products Pty Ltd PM-2011-00795-3-4 New chemical entity 17/12/12
Vernakalant Brinavess Merck Sharp & Dohme (Australia) Pty Ltd PM-2010-01025-3-3 New chemical entity 12/11/12
Vero cell derived / Inactivated influenza vaccine / Split virus Preflucel Baxter Healthcare Pty Ltd PM-2010-03274-3-2 New biological entity 06/07/12
Vilanterol trifenatate / fluticasone furoate Breo Ellipta GlaxoSmithKline Australia Pty Ltd PM-2012-01970-3-5 New chemical entity, New combination 25/06/14
Vilanterol trifenatate and Umeclidinium bromide Anoro Ellipta GlaxoSmithKline Australia Pty Ltd PM-2013-00332-1-5 New fixed dose combination 08/04/15
Vildagliptin Galvus / Xiliarx Novartis Pharmaceuticals Australia Pty Limited PM-2009-00158-3-5 New chemical entity 23/02/10
Vildagliptin Xiliarx / Galvus Novartis Pharmaceuticals Australia Pty Limited PM-2009-00158-3-5 New chemical entity 23/02/10
Vildagliptin / Metformin hydrochloride Galvumet / Sobrea Novartis Pharmaceuticals Australia Pty Limited PM-2009-00972-3-5 New fixed combination 07/12/10
Vildagliptin / Metformin hydrochloride Sobrea / Galvumet Novartis Pharmaceuticals Australia Pty Limited PM-2009-00972-3-5 New fixed combination 07/12/10
Vinflunine ditartrate Javlor Pierre Fabre Medicament Australia Pty Ltd PM-2009-03102-3-4 New chemical entity 07/02/11
Vinorelbine Navelbine Pierre Fabre Medicament Australia Pty Ltd PM-2010-03252-3-4 Extension of indications 30/05/12
Vismodegib Erivedge Roche Products Pty Ltd PM-2012-00329-3-4 New chemical entity 13/09/13
Voriconazole Vfend Pfizer Australia Pty Ltd PM-2011-03524-3-2 Extension of indications 21/05/13
Vortioxetine hydrobromide Brintellix Lundbeck Australia Pty Ltd PM-2012-03463-1-1 New chemical entity 08/07/14

Z

Active Ingredient Product Name Sponsor Submission Number Submission Type AusPAR Date
Ziprasidone mesilate Zeldox IM Pfizer Australia Pty Ltd PM-2008-1737-1 New dosage form 18/12/09
Zoledronic acid Aclasta / Osteovan Novartis Australia Pty Ltd PM-2010-01920-3-5 Major variation 31/08/11
Zoledronic acid Osteovan / Aclasta Novartis Australia Pty Ltd PM-2010-01920-3-5 Major variation 31/08/11
Zonisamide Zonegran SciGen Australia Pty Ltd PM-2011-03861-3-1 Extension of indications 22/07/13