Browse AusPARs by sponsor

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 sponsor is the person or company responsible for applying to the TGA to have their medicine included in the Australian Register of Therapeutic Goods.

Please be aware that the AusPAR contains the 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

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
A Menarini Australia Pty Ltd Anakinra Kineret PM-2013-04579-1-3 Major variation (extension of indications) 30/10/15
A Menarini Australia Pty Ltd Febuxostat (FBX) Adenuric PM-2012-03425-1-3 New chemical entity 08/01/15
A Menarini Australia Pty Ltd Avanafil Spedra PM-2014-02782-1-3 New chemical entity 27/10/16
A Menarini Australia Pty Ltd Aclidinium bromide Bretaris Genuair PM-2012-04170-1-5 New chemical entity 08/09/14
A. Menarini Australia Pty Ltd Fentanyl citrate Abstral PM-2011-03151-3-1 Major variation (new dosage form) 30/10/13
Abbott Australasia Pty Ltd Fenofibrate Lipidil PM-2012-02387-3-5 Extension of indications 14/04/14
Abbott Australasia Pty Ltd Pitavastatin Livalo PM-2010-02898-3-3 New chemical entity 02/09/13
Abbott Australasia Pty Ltd Leuprorelin acetate Lucrin Depot / Lucrin XL Depot PM-2009-00544-3-4 New strength, New route of administration 30/07/10
Abbott Australasia Pty Ltd (AbbVie Pty Ltd) Adalimumab Humira PM-2012-02255-3-3 Extension of indications 22/01/14
Abbott Products Pty Ltd Pancreatic extract Creon Micro PM-2009-02729-3-1 New formulation 28/09/10
Abbott Products Pty Ltd Omega-3-acid ethyl esters 90 Omacor PM-2008-3043-3 New chemical entity 28/07/10
AbbVie Pty Ltd Adalimumab (rch) Humira PM-2012-01954-3-1 Extension of indications 25/10/13
AbbVie Pty Ltd Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir (as sodium salt) Viekira Pak PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
AbbVie Pty Ltd Dasabuvir (as sodium salt) and Paritaprevir / Ritonavir / Ombitasvir Viekira Pak PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
AbbVie Pty Ltd Adalimumab (rch) Humira PM-2014-01048-1-3 Extension of indications 10/12/15
AbbVie Pty Ltd Adalimumab Humira PM-2015-01149-1-3 Extension of indications 20/03/17
AbbVie Pty Ltd Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin Viekira Pak-RBV PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
AbbVie Pty Ltd Ritonavir / Paritaprevir / Ombitasvir and Dasabuvir (as sodium salt) and Ribavirin Viekira Pak-RBV PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
AbbVie Pty Ltd Adalimumab (rch) Humira PM–2014-04326-1-4 Major variation; extension of indications 12/07/16
AbbVie Pty Ltd Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir (as sodium salt) and Ribavirin Viekira Pak-RBV PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
AbbVie Pty Ltd Adalimumab Humira PM-2013-01154-1-1 Extension of indications, New strength 05/08/14
AbbVie Pty Ltd Dasabuvir (as sodium salt) and Ribavirin and Paritaprevir / Ritonavir / Ombitasvir Viekira Pak-RBV PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
AbbVie Pty Ltd Ribavirin and Dasabuvir (as sodium salt) and Paritaprevir / Ritonavir / Ombitasvir Viekira Pak-RBV PM-2014-01438-1-2 New chemical entity in a fixed dose combination 24/03/17
AbbVie Pty Ltd Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir (as sodium salt) Viekira Pak PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
AbbVie Pty Ltd Ritonavir / Ombitasvir / Paritaprevir and Dasabuvir (as sodium salt) Viekira Pak PM-2014-01436-1-2 New chemical entity in a fixed dose combination 24/03/17
Abraxis BioScience Australia Pty Ltd Nanoparticle albumin-bound (nab) paclitaxel Abraxane PM-2012-01185-3-4 Extension of indications 09/01/14
Abraxis BioScience Australia Pty Ltd Nanoparticle albumin-bound (nab) paclitaxel Abraxane PM-2013-01523-1-4 Extension of indications 17/06/14
Accord Healthcare Pty Ltd Alendronic acid Alendraccord / Alendrocor / Pharmacor Alendronate PM-2009-01135-3-5 New generic 16/02/11
Accord Healthcare Pty Ltd Alendronic acid Pharmacor Alendronate / Alendraccord / Alendrocor PM-2009-01135-3-5 New generic 16/02/11
Actelion Pharmaceuticals Australia Pty Ltd Macitentan Opsumit PM-2012-04112-1-3 New chemical entity 28/04/14
Actelion Pharmaceuticals Australia Pty Ltd Collagenase clostridium histolyticum Xiaflex PM-2012-01472-3-3 New biological entity 18/11/13
Actelion Pharmaceuticals Australia Pty Ltd Miglustat Zavesca PM-2008-3187-1 Extension of indications 09/03/10
Actelion Pharmaceuticals Australia Pty Ltd Collagenase clostridium histolyticum Xiaflex PM-2014-04262-1-3 Extension of indications 02/08/16
Actelion Pharmaceuticals Australia Pty Ltd Bosentan Tracleer PM-2010-02897-3-4 Major variation (extension of indications) 05/09/12
Actelion Pharmaceuticals Pty Ltd Selexipag Uptravi PM-2014-04586-1-3 New chemical entity 08/11/16
AFT Pharmaceuticals Pty Ltd Fomepizole Antizol PM-2015-02803-1-3 New chemical entity 17/08/17
AFT Pharmaceuticals Pty Ltd Diltiazem hydrochloride Ano-Cream PM-2015-01099-1-1 Major variation (new dosage form) 10/05/17
Alcon Laboratories (Australia) Pty Ltd Brinzolamide / Timolol Maleate Azarga PM-2008-3124-5 New fixed combination 19/02/10
Alcon Laboratories (Australia) Pty Ltd Timolol Maleate / Brinzolamide Azarga PM-2008-3124-5 New fixed combination 19/02/10
Alcon Laboratories (Australia) Pty Ltd Nepafenac Ilevro PM-2014-00379-1-2 New chemical entity 23/12/15
Alcon Laboratories Australia Pty Ltd Ocriplasmin Jetrea PM-2012-04123-1-5 New biological entity 10/11/14
Alexion Pharmaceuticals Australia Pty Ltd Asfotase alfa (rch) Strensiq PM-2014-03845-1-3 New chemical entity 01/07/16
Allergan Australia Pty Ltd Brimonidine tartrate Alphagan P / Enidin P PM-2008-03768-3-5 New strength, Change in formulation, New trade names 24/05/10
Allergan Australia Pty Ltd Deoxycholic acid Belkyra PM-2014-04251-1-5 New chemical entity 06/04/17
Allergan Australia Pty Ltd Brimonidine tartrate Enidin P / Alphagan P PM-2008-03768-3-5 New strength, Change in formulation, New trade names 24/05/10
Allergan Australia Pty Ltd Cyclosporin Restasis PM-2009-03746-3-5 Extension of indications, New dosage form 22/11/11
Allergan Australia Pty Ltd Dexamethasone Ozurdex PM-2014-00332-1-5 Extension of indications 25/10/16
Allergan Australia Pty Ltd Bimatoprost Latisse PM-2012-02668-3-5 Extension of indications 18/07/14
Allergan Australia Pty Ltd Dexamethasone Ozurdex PM-2009-00795-3-5 Extension of indications, New dose form, New route of administration 19/10/11
Allergan Australia Pty Ltd Botulinum toxin type A Botox PM-2012-01467-3-3 Major variation (extension of indications) 23/10/13
Allergan Australia Pty Ltd Botulinum toxin type A Botox PM-2009-03219-3-1 Extension of indications 15/06/11
Allergan Australia Pty Ltd Botulinum toxin type A Botox PM-2010-03508-3-3 Extension of indications 06/07/12
Amgen Australia Pty Ltd Panitumumab Vectibix PM-2010-01972-3-4 Major variation (extension of indications) 07/05/12
Amgen Australia Pty Ltd Denosumab Prolia PM-2009-00390-3-5 New biological entity 26/10/10
Amgen Australia Pty Ltd Denosumab Xgeva PM-2010-02051-3-4 New indication, New strength 30/11/11
Amgen Australia Pty Ltd Denosumab Prolia PM-2012-02302-3-5 Extension of indications 28/01/14
Amgen Australia Pty Ltd Denosumab Xgeva PM-2012-04329-1-4 Extension of indications 17/04/14
Amgen Australia Pty Ltd Evolocumab (rch) Repatha PM-2014-03144-1-3 New biological entity 03/05/16
Amgen Australia Pty Ltd Talimogene laherparepvec Imlygic PM-2014-03464-1-4 New biological entity 31/05/16
ARIAD Pharmaceuticals Australia Pty Ltd Ponatinib Iclusig PM-2013-02061-1-4 New chemical entity 16/04/15
Aspen Pharma Pty Ltd Thyroxine sodium Thyroxine Aspen, Aspen Thyroxine, Eltroxin PM-2012-04477-1-5 New generic, New strength 12/06/14
Aspen Pharma Pty Ltd Thyroxine sodium Aspen Thyroxine, Eltroxin, Thyroxine Aspen PM-2012-04477-1-5 New generic, New strength 12/06/14
Aspen Pharma Pty Ltd Thyroxine sodium Eltroxin, Aspen Thyroxine, Thyroxine Aspen PM-2012-04477-1-5 New generic, New strength 12/06/14
Aspen Pharma Pty Ltd Voriconazole Vorcon PM-2015-00409-1-2 New generic medicine 29/06/17
Aspen Pharmacare Australia Pty Ltd Filgrastim Tevagrastim PM-2009-1996-3-4 Similar biological medicinal product 17/10/11
Astellas Pharma Australia Pty Ltd Enzalutamide Xtandi PM-2013-01155-1-4 New chemical entity 24/11/14
Astellas Pharma Australia Pty Ltd Enzalutamide Xtandi PM-2014-03154-1-4 Extension of indications 23/03/16
Astellas Pharma Australia Pty Ltd Micafungin (as sodium) Mycamine PM-2011-04271-3-2 New chemical entity 09/08/13
Astellas Pharma Australia Pty Ltd Mirabegron Betmiga PM-2012-01928-3-3 New chemical entity 09/01/14
AstraZeneca Pty Ltd Ticagrelor Brilinta PM-2015-01532-1-3 New indication, New strength 31/05/17
AstraZeneca Pty Ltd Naloxegol oxalate Movantik PM-2014-03892-1-1 New chemical entity 01/06/16
AstraZeneca Pty Ltd Esomeprazole / Naproxen Vimovo PM 2010-00846-3-3 New fixed combination 09/11/11
AstraZeneca Pty Ltd Ticagrelor Brilinta PM-2009-03523-3-3 New chemical entity 12/07/11
AstraZeneca Pty Ltd Lesinurad Zurampic PM-2014-04708-1-3 New chemical entity 20/09/16
AstraZeneca Pty Ltd Budesonide / Eformoterol fumarate dihydrate Symbicort Turbuhaler 200/6, 400/12 / Symbicort Rapihaler 200/6 PM-2008-1992-5 Extension of indications 20/10/10
AstraZeneca Pty Ltd Naproxen / Esomeprazole Vimovo PM 2010-00846-3-3 New fixed combination 09/11/11
AstraZeneca Pty Ltd Fentanyl (as citrate) Pecfent PM-2013-01123-1-1 Major variation 20/05/14
AstraZeneca Pty Ltd Dapagliflozin / Saxagliptin Qtern PM-2015-02415-1-5 New fixed dose combination 06/10/17
AstraZeneca Pty Ltd Ceftaroline fosamil Zinforo PM-2011-03149-3-2 New chemical entity 22/05/13
AstraZeneca Pty Ltd Budesonide / Eformoterol Symbicort Rapihaler PM-2008-03789-3-5 New strengths, Extension of indications, New dosing range, Other quality changes 26/02/13
AstraZeneca Pty Ltd Vandetanib Caprelsa PM-2011-03002-3-4 New chemical entity 07/08/13
AstraZeneca Pty Ltd Saxagliptin / Dapagliflozin Qtern PM-2015-02415-1-5 New fixed dose combination 06/10/17
AstraZeneca Pty Ltd Quetiapine (as fumarate) Seroquel, Seroquel XR PM-2008-03436-1 Extension of indications 13/04/10
AstraZeneca Pty Ltd Gefitinib Iressa PM-2009-02058-3-4 Extension of indications 29/06/10
AstraZeneca Pty Ltd Ropivacaine Naropin PM-2009-01406-3-1 Extension of indications 23/04/10
AstraZeneca Pty Ltd Eformoterol / Budesonide Symbicort Rapihaler PM-2008-03789-3-5 New strengths, Extension of indications, New dosing range, Other quality changes 26/02/13
AstraZeneca Pty Ltd Dapagliflozin (as propanediol monohydrate) / Metformin hydrochloride (HCl) Xigduo XR 10/500, Xigduo XR 10/1000, Xigduo XR 5/1000 PM-2013-01515-1-5 Fixed dose combination 17/12/14
AstraZeneca Pty Ltd Rosuvastatin Crestor / Visacor PM-2009-01470-3-3 Extension of indications 25/05/11
AstraZeneca Pty Ltd Eformoterol fumarate dihydrate / Budesonide Symbicort Turbuhaler 200/6, 400/12 / Symbicort Rapihaler 200/6 PM-2008-1992-5 Extension of indications 20/10/10
AstraZeneca Pty Ltd Metformin hydrochloride (HCl) / Dapagliflozin (as propanediol monohydrate) Xigduo XR 10/500, Xigduo XR 10/1000, Xigduo XR 5/1000 PM-2013-01515-1-5 Fixed dose combination 17/12/14
AstraZeneca Pty Ltd Rosuvastatin Visacor / Crestor PM-2009-01470-3-3 Extension of indications 25/05/11
AstraZeneca Pty Ltd Aspirin / Esomeprazole Axanum PM-2010-03829-3-3 New fixed combination 09/08/12
AstraZeneca Pty Ltd Esomeprazole / Aspirin Axanum PM-2010-03829-3-3 New fixed combination 09/08/12

B

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Bausch & Lomb (Australia) Pty Ltd Besifloxacin hydrochloride Besivance PM-2012-02740-3-2 New chemical entity 03/02/14
Bausch & Lomb (Australia) Pty Ltd Loteprednol etabonate Lotemax PM-2012-03141-1-5 New chemical entity 17/04/14
Baxalta Australia Pty Ltd Irinotecan (as sucrosofate) Onivyde PM-2015-03196-1-4 New chemical entity 05/10/17
Baxter Healthcare Pty Ltd Pandemic influenza vaccine Pandemic Influenza Vaccine H5N1 Baxter PM-2008-1961-2 New biological entity 09/12/10
Baxter Healthcare Pty Ltd Split virus / Vero cell derived / Inactivated influenza vaccine Preflucel PM-2010-03274-3-2 New biological entity 06/07/12
Baxter Healthcare Pty Ltd Inactivated influenza vaccine / Split virus / Vero cell derived Preflucel PM-2010-03274-3-2 New biological entity 06/07/12
Baxter Healthcare Pty Ltd 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 PM-2012-00805-3-1 New fixed combination 02/10/13
Baxter Healthcare Pty Ltd Vero cell derived / Inactivated influenza vaccine / Split virus Preflucel PM-2010-03274-3-2 New biological entity 06/07/12
Baxter Healthcare Pty Ltd 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 PM-2012-00805-3-1 New fixed combination 02/10/13
Baxter Healthcare Pty Ltd Fibrin adhesive/sealant Artiss PM-2010-03599-3-4 Extension of indications 09/02/12
Baxter Healthcare Pty Ltd 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 PM-2012-00805-3-1 New fixed combination 02/10/13
Baxter Healthcare Pty Ltd Nonacog gamma Rixubis PM-2012-03758-1-4 New biological entity 14/04/14
Baxter Healthcare Pty Ltd 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 PM-2012-00805-3-1 New fixed combination 02/10/13
Baxter Healthcare Pty Ltd Fibrin sealant Tisseel VH/SD PM-2009-00290-3-4 Extension of indications 06/04/10
Baxter Healthcare Pty Ltd Fibrin sealant Artiss PM-2009-01572-3-4 New biological entity 03/08/10
Baxter Healthcare Pty Ltd Fibrin sealant / adhesive / haemostatic agent Tisseel VH/SD PM-2010-03271-3-4 Extension of indications, Additional method of administration 03/05/12
Bayer Australia Limited Rivaroxaban Xarelto PM-2010-03901-3-3 Extension of indications 13/09/12
Bayer Australia Limited Radium (223Ra) dichloride Xofigo PM-2013-00738-1-2 New chemical entity 10/07/14
Bayer Australia Limited Rivaroxaban Xarelto PM-2012-01179-3-3 Extension of indications 02/10/13
Bayer Australia Limited Aflibercept Eylea PM-2010-03802-3-5 New chemical entity 30/07/12
Bayer Australia Limited Rivaroxaban Xarelto PM-2011-03916-3-3 Extension of indications, New strength 11/11/13
Bayer Australia Limited Regorafenib Stivarga PM-2012-02342-3-4 New chemical entity 07/02/14
Bayer Australia Limited Vardenafil Levitra PM-2009-02689-3-3 New dosage form, Change in dosage instructions 12/01/11
Bayer Australia Limited Aflibercept (rch) Eylea PM-2012-03146-3-5 Extension of indications, Changes to Product Information 04/08/14
Bayer Australia Limited Riociguat Adempas PM-2013-00307-1-3 New chemical entity 12/06/14
Bayer Australia Limited Dienogest Visanne PM-2009-00539-3-5 Extension of indications 21/09/10
Bayer Australia Limited Dienogest / Oestradiol valerate Qlaira PM-2009-02910-3-5 Extension of indications 28/03/11
Bayer Australia Limited Levonorgestrel Jaydess PM-2012-01933-3-5 Major variation (new strength, new indication, modified deliver system) 05/02/14
Bayer Australia Limited Oestradiol valerate / Dienogest Qlaira PM-2009-02910-3-5 Extension of indications 28/03/11
Bayer Australia Ltd Gadobutrol Gadovist 1.0 PM-2015-01572-1-2 Major variation 31/01/17
Bayer Australia Ltd Drospirenone and ethinyloestradiol (as betadex clathrate) YAZFlex PM-2010-03613-3-5 Change in dosage regimen 14/10/14
Bayer Australia Ltd Ethinyloestradiol (as betadex clathrate) and Drospirenone YAZFlex PM-2010-03613-3-5 Change in dosage regimen 14/10/14
Bayer Australia Ltd Sorafenib Nexavar PM-2013-02057-1-4 Extension of indications, Changes to Product Information 06/08/14
Bayer Australia Ltd Gadobutrol Gadovist PM-2013-04968-1-2 Extension of indications 01/06/15
Bayer Australia Ltd Regorafenib Stivarga PM-2013-04954-1-4 Extension of indications 19/11/15
Bayer Australia Ltd Aflibercept Eylea PM-2013-04198-1-1 Extension of indications 21/07/15
Besins Healthcare Australia Pty Ltd Progesterone Prometrium / Utrogestan PM-2014-03908-1-5 Extension of indications 01/06/17
Besins Healthcare Australia Pty Ltd Progesterone Utrogestan / Prometrium PM-2014-03908-1-5 Extension of indications 01/06/17
Biogen Australia Pty Ltd Daclizumab Zinbryta PM-2015-01556-1 New chemical entity 04/05/17
Biogen Idec Australia Pty Ltd Dimethyl fumarate Tecfidera PM-2012-00808-3-1 New chemical entity 22/10/13
Biogen Idec Australia Pty Ltd Fampridine Fampyra PM-2010-00524-3-1 New chemical entity 15/06/11
Biogen Idec Australia Pty Ltd Efmoroctocog alfa (rhu) Eloctate PM-2013-01157-1-4 New biological entity 17/03/15
Biogen Idec Australia Pty Ltd Eftrenonacog alfa Alprolix PM-2013-00745-1-4 New biological entity 03/11/14
Biogen Idec Australia Pty Ltd Peginterferon beta 1a (rch) Plegridy PM-2013-02425-1-1 Biological medicine 05/02/15
BioMarin Pharmaceutical Australia Pty Ltd Elosulfase alfa (rch) Vimizim PM-2013-02807-1-3 New chemical entity 08/04/15
Biotech Regulatory Solutions Catumaxomab Removab PM-2010-03132-3-4 New chemical entity 11/03/14
Boehringer Ingelheim Pty Limited Linagliptin Trajenta PM-2012-01168-3-5 Extension of indications 26/09/13
Boehringer Ingelheim Pty Limited Linagliptin / Metformin HCl Trajentamet PM-2011-03536-3-5 New fixed combination 26/09/13
Boehringer Ingelheim Pty Limited Telmisartan Micardis / Pritor PM-2009-00165-3-3 Extension of indications 22/04/10
Boehringer Ingelheim Pty Limited Afatinib (as dimaleate) Giotrif PM-2012-02708-3-4 New chemical entity 14/04/14
Boehringer Ingelheim Pty Limited Telmisartan Pritor / Micardis PM-2009-00165-3-3 Extension of indications 22/04/10
Boehringer Ingelheim Pty Limited Tiotropium bromide Spiriva Respimat / Favint Respimat PM-2014-00350-1-5 Extension of indications 25/11/16
Boehringer Ingelheim Pty Limited Telmisartan / Amlodipine Twynsta PM-2009-03138-3-3 New fixed dose combination 14/02/11
Boehringer Ingelheim Pty Limited Nevirapine Viramune XR PM-2010-03093-3-2 New dosage form 19/03/12
Boehringer Ingelheim Pty Limited Alteplase Actilyse PM-2009-02729-3-1 Extension of indications 28/09/10
Boehringer Ingelheim Pty Limited Olodaterol (as hydrochloride) Striverdi Respimat PM-2012-01920-3-5 New chemical entity 27/03/14
Boehringer Ingelheim Pty Limited Metformin HCl / Linagliptin Trajentamet PM-2011-03536-3-5 New fixed combination 26/09/13
Boehringer Ingelheim Pty Limited Dabigatran etexilate mesilate Pradaxa PM-2010-00120-3-3 Extension of indications, New strength, Changes to currently approved strengths 24/05/11
Boehringer Ingelheim Pty Limited Amlodipine / Telmisartan Twynsta PM-2009-03138-3-3 New fixed dose combination 14/02/11
Boehringer Ingelheim Pty Ltd Nintedanib esilate Ofev / Vargatef PM-2014-01847-1-4 New chemical entity 08/02/16
Boehringer Ingelheim Pty Ltd Nintedanib esilate Vargatef / Ofev PM-2014-01847-1-4 New chemical entity 08/02/16
Boehringer Ingelheim Pty Ltd Idarucizumab Praxbind PM-2015-00707-1-3 New biological medicine 25/10/16
Boehringer Ingelheim Pty Ltd Empagliflozin Jardiance PM-2013-00674-1-5 New chemical entity 27/01/15
Boehringer Ingelheim Pty Ltd Dabigatran etexilate Pradaxa PM-2013-02038-1-3 Major variation (extension of indications) 04/01/16
Boehringer Ingleheim (Australia) Pty Ltd Linagliptin Trajenta PM-2010-02400-3-5 New chemical entity 12/12/11
Bristol-Myers Squibb / AstraZeneca Saxagliptin Onglyza PM-2010-03800-3-5 Major variation (new strength, new patient group, change in dosage) 25/06/12
Bristol-Myers Squibb Australia Pty Ltd Apixaban Eliquis PM-2014-00349-1-3 Extension of indications 11/11/15
Bristol-Myers Squibb Australia Pty Ltd Nivolumab Opdivo PM-2014-03852-1-4 New chemical entity 23/08/16
Bristol-Myers Squibb Australia Pty Ltd Dapagliflozin propanediol monohydrate Empliciti / Forxiga / Appebb / AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin / Edistride PM-2010-03812-35 New chemical entity 14/01/13
Bristol-Myers Squibb Australia Pty Ltd Saxagliptin (as hydrochloride) Onglyza PM-2011-01174-3-5 Extension of indications 13/03/13
Bristol-Myers Squibb Australia Pty Ltd Dapagliflozin propanediol monohydrate Forxiga / Appebb / AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin / Edistride / Empliciti PM-2010-03812-35 New chemical entity 14/01/13
Bristol-Myers Squibb Australia Pty Ltd Saxagliptin / Metformin hydrochloride Kombiglyze PM-2012-00296-3-5 New fixed dose combination 15/10/13
Bristol-Myers Squibb Australia Pty Ltd Belatacept Nulojix PM-2010-03075-3-2 New chemical entity 30/07/12
Bristol-Myers Squibb Australia Pty Ltd Dapagliflozin propanediol monohydrate BMS-AZ Dapagliflozin / Edistride / Empliciti / Forxiga / Appebb / AZ Dapagliflozin / BMS Dapagliflozin PM-2010-03812-35 New chemical entity 14/01/13
Bristol-Myers Squibb Australia Pty Ltd Ipilimumab (rch) Yervoy/ Winglore PM-2013-04125-1-4 Major variation (new indication) 06/02/17
Bristol-Myers Squibb Australia Pty Ltd Ipilimumab Winglore / Yervoy PM-2010-02212-3-4 New biological entity 10/08/11
Bristol-Myers Squibb Australia Pty Ltd Ipilimumab Yervoy / Winglore PM-2010-02212-3-4 New biological entity 10/08/11
Bristol-Myers Squibb Australia Pty Ltd Metformin hydrochloride / Saxagliptin Kombiglyze PM-2012-00296-3-5 New fixed dose combination 15/10/13
Bristol-Myers Squibb Australia Pty Ltd Asunaprevir Sunvepra PM- 2014-00648-1-2 New chemical entity 14/12/15
Bristol-Myers Squibb Australia Pty Ltd Ipilimumab (rch) Winglore/Yervoy PM-2013-04125-1-4 Major variation (new indication) 06/02/17
Bristol-Myers Squibb Australia Pty Ltd Saxagliptin hydrochloride Onglyza PM-2008-03469-3-5 New chemical entity 13/04/11
Bristol-Myers Squibb Australia Pty Ltd Daclatasvir dihydrochloride Daklinza PM-2014-00647-1-2 New chemical entity 14/12/15
Bristol-Myers Squibb Australia Pty Ltd Dasatinib Sprycel PM-2010-01583-3-4 Major variation (extension of indications) 11/07/11
Bristol-Myers Squibb Australia Pty Ltd Apixaban Eliquis PM-2010-01492-3-3 New chemical entity 20/09/11
Bristol-Myers Squibb Australia Pty Ltd Apixaban Eliquis PM-2011-03165-3-3 Extension of indications 21/06/13
Bristol-Myers Squibb Australia Pty Ltd Abatacept (rch) Orencia PM-2010-03115-3-3 Major variation (new dosage form, new route of administration) 26/04/12
Bristol-Myers Squibb Australia Pty Ltd Abatacept (rch) Orencia PM-2008-03683-3-3 Extension of indications 04/03/10
Bristol-Myers Squibb Australia Pty Ltd Dapagliflozin propanediol monohydrate Appebb / AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin / Edistride / Empliciti / Forxiga PM-2010-03812-35 New chemical entity 14/01/13
Bristol-Myers Squibb Australia Pty Ltd Abatacept (rch) Orencia PM-2010-00413-3-3 Extension of indications 15/06/11
Bristol-Myers Squibb Australia Pty Ltd Atazanavir Reyataz PM-2012-01034-3-2 Major variation (change in paediatric dosage regimen, PI updates) 21/10/13
Bristol-Myers Squibb Australia Pty Ltd Dapagliflozin propanediol monohydrate AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin / Edistride / Empliciti / Forxiga / Appebb PM-2010-03812-35 New chemical entity 14/01/13
Bristol-Myers Squibb Australia Pty Ltd Dapagliflozin propanediol monohydrate Edistride / Empliciti / Forxiga / Appebb / AZ Dapagliflozin / BMS Dapagliflozin / BMS-AZ Dapagliflozin PM-2010-03812-35 New chemical entity 14/01/13
Bristol-Myers Squibb Australia Pty Ltd / Sanofi-Aventis Australia Pty Ltd Clopidogrel / Aspirin DuoCover / CoPlavix PM-2010-00534-3-4 / 2010-00535-3-3 Extension of indications 28/07/11
Bristol-Myers Squibb Australia Pty Ltd / Sanofi-Aventis Australia Pty Ltd Aspirin / Clopidogrel DuoCover / CoPlavix PM-2010-00534-3-4 / 2010-00535-3-3 Extension of indications 28/07/11
Bristol-Myers Squibb Pharmaceuticals Pty Ltd Aripiprazole Abilify PM-2010-00571-3-1 Extension of indications 03/03/11

C

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Cedarglen Investments Pty Ltd C1 esterase inhibitor Cinryze PM-2010-03159-3-2 New chemical entity 29/07/13
Celgene Australia Pty Ltd Romidepsin Istodax PM-2012-01446-3-4 New chemical entity 20/11/13
Celgene Australia Pty Ltd Pomalidomide Pomalyst PM-2013-02037-1-4 New chemical entity 13/10/14
Celgene Pty Ltd Azacitidine Vidaza PM-2012-00341-3-4 Major variation (route of administration) 20/08/13
Celgene Pty Ltd Apremilast Otezla PM-2013-04920-1-3 New chemical entity 22/10/15
Celgene Pty Ltd Lenalidomide Revlimid PM-2014-02792-1-4 Extension of indications, New strength 05/02/16
Commercial Eyes Pty Ltd Lurasidone hydrochloride Latuda PM-2012-04452-1-1 New chemical entity 20/06/14
Commercial Eyes Pty Ltd Melatonin Circadin PM-2008-2125-1 New chemical entity 28/11/09
Commercial Eyes Pty Ltd Alprostadil Proshaeos PM-2014-03512-1-3 Major variation 09/06/16
CSL Behring (Australia) Pty Ltd Albutrepenonacog alfa (rch) Idelvion PM-2015-01850-1-4 New biological entity 26/09/17
CSL Behring Ltd Normal human immunoglobulin Hizentra PM-2013-00301-2-2 New biological entity 25/06/14
CSL Bioplasma Ltd Immunoglobulin - normal (human) Intragam 10 NF PM-2009-01544-3-2 Extension of indications, New dosage 18/10/11
CSL Limited Tapentadol Palexia SR PM-2009-02489-3-1 New chemical entity 28/02/11
CSL Limited Human fibrinogen RiaSTAP PM-2009-01838-3-4 New chemical entity 13/10/10
CSL Limited Immunoglobulin - normal (human) Evogam PM-2010-01887-3-2 Major variations (new strength, new route of administration, change in manufacture and tradename) 07/05/12
CSL Limited Albumin (human) Albunate 5 / Albunate 20 / Albunate 25 PM-2014-01051-1-5 New biological medicine 02/05/17
CSL Limited Albumin (human) Albunate 20 / Albunate 25 / Albunate 5 PM-2014-01051-1-5 New biological medicine 02/05/17
CSL Limited Albumin (human) Albunate 25, Albunate 5 and Albunate 20 PM-2014-01051-1-5 New biological medicine 02/05/17
CSL Limited Albumin (human) Albumex 20 / Albumex 5 / Albumex 4 PM-2010-02082-3-5 Extension of indications 27/07/11
CSL Limited Tapentadol Palexia IR PM-2009-02488-3-1 New chemical entity 17/11/10
CSL Limited, Bioplasma Division Human C1 esterase inhibitor Berinert PM-2008-03232-3-2 New chemical entity 14/01/10
CSL Limited, Bioplasma Division Human Prothrombin Complex Beriplex P/N PM-2008-2935-4 New chemical entity 15/01/10

D

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Delpharm Consultants Pty Limited Remestemcel-L ex vivo adult human mesenchymal stem cells Prochymal PM-2011-01529-3-2 New biological entity 05/03/15

E

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Eisai Australia Pty Ltd Eribulin mesilate Halaven PM-2011-01624-3-4 New chemical entity 17/05/13
Eisai Australia Pty Ltd Lenvatinib mesilate Lenvima PM-2014-04321-1-4 New chemical entity 30/08/16
Eisai Australia Pty Ltd/Commercial Eyes Pty Ltd Perampanel (as hemisesquihydrate) Fycompa PM-2013-00324-1-1 New chemical entity 14/10/14
Eli Lilly Australia Ptd Ltd Dulaglutide rch Trulicity PM-2013-03639-1-5 New chemical entity 27/07/15
Eli Lilly Australia Pty Ltd Teriparatide Forteo PM-2009-02138-3-5 Major variation (extension of treatment duration) 07/09/10
Eli Lilly Australia Pty Ltd Somatropin Humatrope PM-2010-00615-3-5 Extension of indications 15/01/13
Eli Lilly Australia Pty Ltd Ixekizumab Taltz PM-2015-01878-1-4 New chemical entity 08/05/17
Eli Lilly Australia Pty Ltd Duloxetine Cymbalta PM-2010-03270-3-1 Extension of indications 06/09/12
Eli Lilly Australia Pty Ltd Insulin glargine Abasria / Abasria KwikPen PM-2013-02802-1-5 Biosimilar (Insulin analogue) 20/08/15
Eli Lilly Australia Pty Ltd Exenatide Byetta / Bydureon PM-2010-02389-3-5 Extension of indications, New dosage form 05/02/13
Eli Lilly Australia Pty Ltd Exenatide Byetta PM-2011-01931-3-5 Major variation (extension of indications) 03/06/13
Eli Lilly Australia Pty Ltd Tadalafil Adcirca PM-2010-01829-3-3 Extension of indications, Additional trade name 20/09/11
Eli Lilly Australia Pty Ltd Tadalafil Cialis PM-2011-03166-3-3 Extension of indications 22/07/13
Emerge Health Pty Ltd Carglumic acid Carbaglu PM-2013-02751-1-3 New chemical entity 02/09/15
ERA Consulting (Australia) Pty Ltd Fentanyl (as citrate) PecFent PM-2011-00911-3-1 Major variation (new dosage form) 19/03/13
ERA Consulting (Australia) Pty Ltd Ulipristal acetate EllaOne PM-2013-04154-1-5 New chemical entity 04/09/15

F

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Ferring Pharmaceuticals Pty Ltd Terlipressin acetate Glypressin PM-2010-03182-3-3 New chemical entity 26/11/12
Ferring Pharmaceuticals Pty Ltd Somatropin Zomacton PM-2008-2954-5 Major variation (new strength, new mode of administration) 01/12/10
Ferring Pharmaceuticals Pty Ltd Budesonide Cortiment PM-2014-04155-1-1 Major variation (new dosage form and new indication) 11/01/16
Ferring Pharmaceuticals Pty Ltd Progesterone Endometrin Pessaries PM-2011-02023-3-5 Major variation (new strength) 12/06/13
Ferring Pharmaceuticals Pty Ltd Degarelix Firmagon PM-2008-2254-4 New chemical entity 16/02/10
Ferring Pharmaceuticals Pty Ltd Triptorelin acetate Decapeptyl PM-2013-04578-1-5 New chemical entity 24/08/15
Ferring Pharmaceuticals Pty Ltd Misoprostol Misodel/ Misopess PM-2012-03740-1-5 Major variation (extension of indication, new dose form, new route of administration) 23/04/14
Ferring Pharmaceuticals Pty Ltd Gonadotrophin - human menopausal Menopur PM-2009-01335-3-5 New chemical entity 12/10/11
Finox Biotech Australia Pty Ltd Follitropin alfa (rch) Afolia / Bemfola PM-2014-03163-1-5 Biosimilar medicine, Extension of indications 08/04/16
Finox Biotech Australia Pty Ltd Follitropin alfa (rch) Bemfola / Afolia PM-2014-03163-1-5 Biosimilar medicine, Extension of indications 08/04/16
Fresenius Kabi Australia Pty Ltd Glucose 42% / SMOFlipid 20% / Aminoven 10% (with or without electrolytes) SmofKabiven / SmofKabiven Electrolyte Free Emulsion PM-2010-02110-3-1 New fixed combination 15/03/12
Fresenius Kabi Australia Pty Ltd Olive oil / Fish oil / Soya oil / Medium chain triglycerides SMOFlipid PM-2008-03674-3-1 New combination 10/06/10
Fresenius Kabi Australia Pty Ltd Soya oil / Medium chain triglycerides / Olive oil / Fish oil SMOFlipid PM-2008-03674-3-1 New combination 10/06/10
Fresenius Kabi Australia Pty Ltd Fish oil / Olive oil / Soya oil / Medium chain triglycerides SMOFlipid PM-2008-03674-3-1 New combination 10/06/10
Fresenius Kabi Australia Pty Ltd Nine trace elements including chromic chloride Addaven PM-2015-01467-1-1 New chemical entity 23/03/17
Fresenius Kabi Australia Pty Ltd SMOFlipid 20% / Aminoven 10% (with or without electrolytes) / glucose 42% SmofKabiven / SmofKabiven Electrolyte Free Emulsion PM-2010-02110-3-1 New fixed combination 15/03/12
Fresenius Kabi Australia Pty Ltd Medium chain triglycerides / Olive oil / Fish oil / Soya oil SMOFlipid PM-2008-03674-3-1 New combination 10/06/10
Fresenius Kabi Australia Pty Ltd Aminoven 10% (with or without electrolytes) / SMOFlipid 20% / glucose 42% SmofKabiven / SmofKabiven Electrolyte Free Emulsion PM-2010-02110-3-1 New fixed combination 15/03/12

G

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Galderma Australia Pty Ltd Clobetasol propionate Clobex PM-2011-01596-3-5 New chemical entity 22/05/13
Galderma Australia Pty Ltd Doxycycline monohydrate Oracea PM-2010-03584-3-4 Extension of indications, New presentation 06/06/13
Galderma Australia Pty Ltd Brimonidine (as tartrate) Mirvaso PM-2013-01459-1-5 New indication, New dosage form, New formulation, New strength 23/01/15
Galderma Australia Pty Ltd Ivermectin Soolantra / Vastreka PM-2014-01877-1-2 Major variation (new dose form, new indications) 09/12/15
Galderma Australia Pty Ltd Ivermectin Vastreka / Soolantra PM-2014-01877-1-2 Major variation (new dose form, new indications) 09/12/15
GE Healthcare Australia Pty Ltd Iodixanol Visipaque PM-2009-00811-3-2 Extension of indications 14/05/10
Generic Partners Sevelamer hydrochloride Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / GenRx Sevelamer / Terry White Chemists Sevelamer PM-2013-00742-1-3 New generic 31/07/17
Generic Partners Sevelamer hydrochloride Phosligand / Sevelamer GPPL / Sevelamer GxP / Seveligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / GenRx Sevelamer / Terry White Chemists Sevelame PM-2013-00742-1-3 New generic 31/07/17
Generic Partners Sevelamer hydrochloride Chemmart Sevelamer / Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / GenRx Sevelamer / Terry White Chemists Sevelamer PM-2013-00742-1-3 New generic 31/07/17
Generic Partners Sevelamer hydrochloride GenRx Sevelamer / Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / Terry White Chemists Sevelame PM-2013-00742-1-3 New generic 31/07/17
Generic Partners Sevelamer hydrochloride Terry White Chemists Sevelame / Sevelamer GPPL / Sevelamer GxP / Seveligand / Phosligand / APO-Sevelamer / APOTEX-Sevelamer / Chemmart Sevelamer / GenRx Sevelamer PM-2013-00742-1-3 New generic 31/07/17
Generic Partners Pty Ltd Gliclazide Gliclazide Gppl MR 30 PM-2015-00426-1-5 New generic medicine 19/07/16
Genzyme Australasia Pty Ltd Plerixafor Mozobil SM-2008-03602-4 New chemical entity 23/07/10
Gilead Sciences Pty Ltd Tenofovir disoproxil fumarate / Emtricitabine Truvada PM-2015-00411-1-2 Extension of indications 10/11/16
Gilead Sciences Pty Ltd Aztreonam Cayston PM-2007-3666-2 New dosage form 02/02/10
Gilead Sciences Pty Ltd Emtricitabine / Tenofovir disoproxil fumarate Truvada PM-2015-00411-1-2 Extension of indications 10/11/16
Gilead Sciences Pty Ltd Adefovir dipivoxil Hepsera PM-2009-00296-3-2 Extension of indications 29/04/10
Gilead Sciences Pty Ltd Cobicistat Tybost PM-2012-02160-3-2 New chemical entity 16/12/13
Gilead Sciences Pty Ltd Sofosbuvir Sovaldi PM-2013-01283-1-2 New chemical entity 05/08/14
Gilead Sciences Pty Ltd Tenofovir disoproxil fumarate / emtricitabine / rilpivirine Eviplera PM-2010-02853-3-2 New chemical entity 27/03/12
Gilead Sciences Pty Ltd Tenofovir disoproxil fumarate / emtricitabine / rilpivirine Eviplera PM-2013-01524-1-2 Extension of indications 15/07/14
Gilead Sciences Pty Ltd Ledipasvir / Sofosbuvir Harvoni PM-2014-00469-1-2 New chemical entity 08/10/15
Gilead Sciences Pty Ltd Elvitegravir / Cobicistat / Emtricitabine / Tenofovir alafenamide (as fumarate) Genvoya PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Gilead Sciences Pty Ltd Emtricitabine / Tenofovir disoproxil fumarate / rilpivirine Eviplera PM-2010-02853-3-2 New chemical entity 27/03/12
Gilead Sciences Pty Ltd Emtricitabine / rilpivirine / tenofovir disoproxil fumarate Eviplera PM-2013-01524-1-2 Extension of indications 15/07/14
Gilead Sciences Pty Ltd Sofosbuvir / Ledipasvir Harvoni PM-2014-00469-1-2 New chemical entity 08/10/15
Gilead Sciences Pty Ltd Cobicistat / Emtricitabine / Tenofovir alafenamide (as fumarate) / Elvitegravir Genvoya PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Gilead Sciences Pty Ltd Rilpivirine / Tenofovir disoproxil fumarate / emtricitabine Eviplera PM-2010-02853-3-2 New chemical entity 27/03/12
Gilead Sciences Pty Ltd Rilpivirine / Tenofovir disoproxil fumarate / emtricitabine Eviplera PM-2013-01524-1-2 Extension of indications 15/07/14
Gilead Sciences Pty Ltd Emtricitabine / Tenofovir alafenamide (as fumarate) Descovy PM-2015-01283-1-3 New fixed dose combination 20/12/16
Gilead Sciences Pty Ltd Emtricitabine / Tenofovir alafenamide (as fumarate) / Elvitegravir / Cobicistat Genvoya PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Gilead Sciences Pty Ltd Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir / Cobicistat Stribild PM-2011-03533-3-2 New fixed dose combination 05/08/13
Gilead Sciences Pty Ltd Cobicistat / Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir Stribild PM-2011-03533-3-2 New fixed dose combination 05/08/13
Gilead Sciences Pty Ltd Tenofovir alafenamide (as fumarate) / Emtricitabine Descovy PM-2015-01283-1-3 New fixed dose combination 20/12/16
Gilead Sciences Pty Ltd Tenofovir alafenamide (as fumarate) / Elvitegravir / Cobicistat / Emtricitabine Genvoya PM-2014-04011-1-2 New chemical entity, New fixed dose combination 28/06/16
Gilead Sciences Pty Ltd Elvitegravir / Tenofovir disoproxil fumarate / Emtricitabine / Cobicistat Stribild PM-2011-03533-3-2 New fixed dose combination 05/08/13
Gilead Sciences Pty Ltd Emtricitabine / Tenofovir disoproxil fumarate/ Elvitegravir / Cobicistat Stribild PM-2011-03533-3-2 New fixed dose combination 05/08/13
Gilead Sciences Pty Ltd Tenofovir disoproxil fumarate Viread PM-2012-01178-3-2 Extension of indications 14/10/13
Gilead Sciences Pty Ltd Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir / Cobicistat Stribild PM-2014-01079-1-2 Extension of indications 01/06/17
Gilead Sciences Pty Ltd Emtricitabine / Elvitegravir / Cobicistat / Tenofovir disoproxil fumarate Stribild PM-2014-01079-1-2 Extension of indications 01/06/17
Gilead Sciences Pty Ltd Elvitegravir Vitekta PM-2012-02159-3-2 New chemical entity 16/12/13
Gilead Sciences Pty Ltd Emtricitabine Emtriva PM-2012-02513-3-2 Major variation (extension of indications) 12/06/14
Gilead Sciences Pty Ltd Idelalisab Zydelig PM-2013-04151-1-4 New chemical entity 14/07/15
Gilead Sciences Pty Ltd Elvitegravir / Cobicistat / Tenofovir disoproxil fumarate / Emtricitabine Stribild PM-2014-01079-1-2 Extension of indications 01/06/17
Gilead Sciences Pty Ltd Cobicistat / Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir Stribild PM-2014-01079-1-2 Extension of indications 01/06/17
GlaxoSmithKline Australia Pty Ltd Ofatumumab Arzerra PM-2009-02159-3-4 New biological entity 15/12/10
GlaxoSmithKline Australia Pty Ltd Hib and group C Meningococcal conjugate vaccine Menitorix PM-2009-00817-3-2 New biological entity (new combination vaccine) 02/08/10
GlaxoSmithKline Australia Pty Ltd Ambrisentan Volibris PM-2014-04323-1-3 Extension of indications 06/07/17
GlaxoSmithKline Australia Pty Ltd Belimumab Benlysta PM-2010-01980-3-2 New biological entity 31/10/12
GlaxoSmithKline Australia Pty Ltd Pneumococcal polysaccharide conjugate vaccine, 10-valent adsorbed Synflorix PM-2010-02793-3-2 Major variation (extension of indications) 22/10/12
GlaxoSmithKline Australia Pty Ltd Mepolizumab (rch) Nucala PM-2014-03872-1-5 New biological entity 08/03/17
GlaxoSmithKline Australia Pty Ltd Meningococcal conjugate vaccine Group C and Hib Menitorix PM-2009-00817-3-2 New biological entity (new combination vaccine) 02/08/10
GlaxoSmithKline Australia Pty Ltd Meningococcal (groups A,C,W-135,Y) polysaccharide tetanus toxoid conjugate vaccine Nimenrix PM-2012-01958-3-2 New chemical entity 04/12/13
GlaxoSmithKline Australia Pty Ltd Pandemrix Pandemic H1N1 influenza vaccine PM-2009-03526-3-2 Major variation 20/10/10
GlaxoSmithKline Australia Pty Ltd Vilanterol trifenatate and Umeclidinium bromide Anoro Ellipta PM-2013-00332-1-5 New fixed dose combination 08/04/15
GlaxoSmithKline Australia Pty Ltd Remifentanil (as hydrochloride) Ultiva PM-2011-00909-3-1 Major variation (new mode of administration) 29/01/13
GlaxoSmithKline Australia Pty Ltd Umeclidinium bromide and Vilanterol trifenatate Anoro Ellipta PM-2013-00332-1-5 New fixed dose combination 08/04/15
GlaxoSmithKline Australia Pty Ltd Retapamulin Altargo PM-2012-01489-3-2 New chemical entity 11/11/13
GlaxoSmithKline Australia Pty Ltd Dutasteride Avodart PM-2009-02236-3-3 Extension of indications 22/09/10
GlaxoSmithKline Australia Pty Ltd Pazopanib hydrochloride Votrient PM-2009-01084-4 New chemical entity 01/09/10
GlaxoSmithKline Australia Pty Ltd Human Papillomavirus Vaccine Types 16 and 18 (recombinant, AS04 adjuvanted) Cervarix PM-2009-02655-3-2 Major variation (extension of indications) 22/06/11
GlaxoSmithKline Australia Pty Ltd Retigabine Trobalt PM-2011-04248-3-1 New chemical entity 17/10/13
GlaxoSmithKline Australia Pty Ltd Dutasteride / Tamsulosin Duodart PM-2009-01559-3-3 New fixed dose combination 20/10/10
GlaxoSmithKline Australia Pty Ltd Pazopanib hydrochloride Votrient PM-2011-01972-3-4 Extension of indications 25/02/13
GlaxoSmithKline Australia Pty Ltd Purified antigen fractions of inactivated split virion A/Indonesia/05/2005 (H5N1) AS03 adjuvanted Prepandrix PM‐2013‐04610‐1‐2 New biological entity 23/12/15
GlaxoSmithKline Australia Pty Ltd Influenza virus haemagglutinin inactivated split influenza vaccine Fluarix Tetra PM-2012-02287-3-2 New chemical/biological entity 06/02/14
GlaxoSmithKline Australia Pty Ltd Dabrafenib mesilate Tafinlar PM-2012-02231-3-4 New chemical entity 09/01/14
GlaxoSmithKline Australia Pty Ltd Human papillomavirus vaccine types 16 and 18 (recombinant AS04 adjuvanted) Cervarix PM-2014-01893-1-2 Major variation 04/01/16
GlaxoSmithKline Australia Pty Ltd Influenza virus haemagglutinin (Type A/California/7/2009 (H1N1)v-like strain adjuvanted to ASO3) Pandemrix H1N1 pandemic influenza vaccine PM-2010-02995-3-2 Major variation (change in patient group, dosing schedule) 12/02/13
GlaxoSmithKline Australia Pty Ltd Eltrombopag olamine Revolade SM- 2009-00082-3-4 New chemical entity 26/10/10
GlaxoSmithKline Australia Pty Ltd Fluticasone furoate / vilanterol trifenatate Breo Ellipta PM-2012-01970-3-5 New chemical entity, New combination 25/06/14
GlaxoSmithKline Australia Pty Ltd Umeclidinium bromide Incruse Ellipta PM-2013-01505-1-5 New chemical entity 09/07/15
GlaxoSmithKline Australia Pty Ltd Lapatinib Tykerb PM-2009-01276-3-4 Extension of indications 17/06/10
GlaxoSmithKline Australia Pty Ltd Trametinib (as dimethyl sulfoxide) Mekinist PM-2012-04134-1-4 New chemical entity 17/03/14
GlaxoSmithKline Australia Pty Ltd Eltrombopag olamine Revolade PM-2012-01934-3-2 Major variation (extension of indications) 03/12/13
GlaxoSmithKline Australia Pty Ltd Vilanterol trifenatate / fluticasone furoate Breo Ellipta PM-2012-01970-3-5 New chemical entity, New combination 25/06/14
GlaxoSmithKline Australia Pty Ltd Lapatinib Tykerb PM-2011-00908-3-4 Extension of indications 12/11/12
GlaxoSmithKline Australia Pty Ltd Tamsulosin / Dutasteride Duodart PM-2009-01559-3-3 New fixed dose combination 20/10/10
Grifols Australia Pty Ltd IVIg Flebogamma 10% DIF PM-2010-03276-3-2 Major variation (new strength) 03/09/13
Grunenthal Pty Ltd Tramadol hydrochloride / Paracetamol Zaldiar PM-2010-3272-3-1 New fixed combination 13/09/12
Grunenthal Pty Ltd Paracetamol / Tramadol hydrochloride Zaldiar PM-2010-3272-3-1 New fixed combination 13/09/12
GSK Australia Pty Ltd Pandemic influenza vaccine Arepanrix H5N1 PM-2009-03131-3-2 New biological entity 01/02/11

H

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Helex-A Pty Ltd Allergen pollen extract of 5 grasses Oralair Sublingual Tablets PM-2009-03500-3-2 New route of administration, New dosage form 15/06/11
Hospira Pty Ltd Filgrastim Nivestim PM-2009-00676-3-4 New chemical entity (biosimilar product) 13/09/10

I

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Ikaria Australia Pty Ltd Terlipressin Lucassin PM-2010-02975-3-1 New chemical entity 27/08/13
Ikaria Australia Pty Ltd Nitric oxide INOmax PM-2014-01399-1-3 Major variation (new indication) 15/05/17
Invida Australia Pty Ltd Granisetron Sancuso PM-2009-02620-3-4 New route of administration, New dosage form 21/06/11
Invida Australia Pty Ltd Indomethacin Indocid PDA PM-2009-03539-3-3 Major variation (change in dosage and patient population) 18/03/11

i

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
iNova Pharmaceuticals (Australia) Pty Ltd Rupatadine Rupafin PM-2009-03232-3-5 New chemical entity 18/05/11

J

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
JACE Pharma Pty Ltd Ceftobiprole medocaril sodium Zevtera PM-2014-03155-1-2 New chemical entity 08/02/16
Janssen Cilag Pty Ltd Golimumab (rmc) Simponi PM-2015-01879-1-3 Extension of indications 19/06/17
Janssen-Cilag Pty Ltd Paliperidone palmitate Invega Sustenna PM-2009-00926-3-1 New salt of a previously approved active ingredient 20/07/10
Janssen-Cilag Pty Ltd Canagliflozin (as hemihydrate) Invokana / Prominad PM-2012-02210-3-5 New chemical entity 03/03/14
Janssen-Cilag Pty Ltd Telaprevir Incivo PM-2010-03576-3-2 New chemical entity 26/10/12
Janssen-Cilag Pty Ltd Bendamustine hydrochloride Ribomustin PM-2013-01517-1-4 New chemical entity 06/01/15
Janssen-Cilag Pty Ltd Canagliflozin (as hemihydrate) Prominad / Invokana PM-2012-02210-3-5 New chemical entity 03/03/14
Janssen-Cilag Pty Ltd Dapoxetine Priligy PM-2007-3614-3 New chemical entity 23/11/10
Janssen-Cilag Pty Ltd Simeprevir (as sodium) Olysio / Janssen Simeprevir PM-2013-01557-1-2 New chemical entity 27/10/14
Janssen-Cilag Pty Ltd Bortezomib Velcade PM-2014-03463-1-4 Extension of indications 26/02/16
Janssen-Cilag Pty Ltd Prucalopride Resotrans PM-2010-03060-3-1 New chemical entity 23/11/11
Janssen-Cilag Pty Ltd Infliximab Remicade PM-2011-00196-3-1 Extension of indications 17/12/12
Janssen-Cilag Pty Ltd Bortezomib Velcade PM-2010-03250-3-4 Extension of indications 30/11/11
Janssen-Cilag Pty Ltd Trabectedin Yondelis PM-2009-01976-3-4 New chemical entity 09/11/10
Janssen-Cilag Pty Ltd Ibrutinib Imbruvica PM-2014-02780-1-4 New chemical entity 02/02/16
Janssen-Cilag Pty Ltd Tacrolimus Prograf-XL PM-2008-03783-3-2 New dosage form 06/05/10
Janssen-Cilag Pty Ltd Simeprevir (as sodium) Janssen Simeprevir / Olysio PM-2013-01557-1-2 New chemical entity 27/10/14
Janssen-Cilag Pty Ltd Bortezomib Velcade PM-2011-00854-3-4 Major variation (route of administration) 16/01/13
Janssen-Cilag Pty Ltd Rilpivirine Edurant PM-2010-03030-3-2 New chemical entity 27/03/12
Janssen-Cilag Pty Ltd Golimumab (rmc) Simponi and Simponi Smartject Injector PM-2012-01202-3-3 Extension of indications, Changes to Product Information 16/08/13
Janssen-Cilag Pty Ltd Ustekinumab Stelara PM-2013-04148-1-3 Extension of indications 09/07/15
Janssen-Cilag Pty Ltd Risperidone Risperdal Consta PM-2008-03495-3-1 Extension of indications 18/06/10
Janssen-Cilag Pty Ltd Golimumab (rmc) Simponi, Simponi smartject injector PM-2013-00215-1-1 Major variation (extension of indications) 19/05/14
Janssen-Cilag Pty Ltd Paliperidone Invega PM-2009-00515-3-1 Extension of indications 14/12/09
Janssen-Cilag Pty Ltd Abiraterone acetate Zytiga PM-2010-03604-3-4 New chemical entity 04/10/12
Janssen-Cilag Pty Ltd Abiraterone acetate Zytiga PM-2012-02706-3-4 Extension of indications 22/01/14
Janssen-Cilag Pty Ltd Paliperidone Invega PM-2011-02378-3-1 Extension of indications 20/05/13
Johnson & Johnson Medical Pty Ltd Fibrin haemostatic agent/sealant Evicel PM-2009-03561-3-4 New chemical entity 11/12/12

K

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Kendle Australia Pty Ltd Clevidipine Cleviprex PM-2008-3132-3 New chemical entity 12/04/10
Kendle R & D Pty Ltd Iloperidone Fanapt PM-2010-02772-3 New chemical entity 18/06/12

L

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
LEO Pharma Pty Ltd Betamethasone / Calcipotriol (as dipropionate) Daivobet 50/500 PM-2011-04144-3-5 Extension of indications 09/08/13
LEO Pharma Pty Ltd Calcipotriol / Betamethasone (as dipropionate) Daivobet 50/500 PM-2011-04144-3-5 Extension of indications 09/08/13
LEO Pharma Pty Ltd Ingenol mebutate Picato 0.015% and 0.05% gel PM-2011-02307-3-5 New chemical entity 06/06/13
Link Medical Products Pty Ltd Methotrexate TREXJECT IN PM-2014-01050-1-3 Major variation (new presentation, new route of administration) 07/06/17
Link Medical Products Pty Ltd Immunoglobulin - normal (human) Intratect PM-2009-02495-3-2 New chemical entity 03/02/11
Link Medical Products Pty Ltd Methotrexate TREXJECT PM-2014-01050-1-3 Major variation (new presentation, new route of administration) 07/06/17
Link Medical Products Pty Ltd Cyclizine lactate Valoid PM-2010-03573-3-1 New chemical entity 15/01/13
Lundbeck (Australia) Pty Ltd Aripiprazole monohydrate Abilify maintena PM-2013-01100-1-1 Major variation (new strength, new dosage form) 25/11/14
Lundbeck Australia Pty Ltd Rasagiline Azilect PM-2010-00798-3-1 New chemical entity 08/02/12
Lundbeck Australia Pty Ltd Vortioxetine hydrobromide Brintellix PM-2012-03463-1-1 New chemical entity 08/07/14
Lundbeck Australia Pty Ltd Nalmefene (as hydrochloride dihydrate) Selincro PM-2013-02690-1-1 New chemical entity 09/08/16

M

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Mayne Pharma International Pty Ltd Ephedrine Hydrochloride Ephedrine Hydrochloride MYX PM-2015-01131-1-3 Major variation (new strength) 22/06/17
Meda Pharmaceuticals Pty Ltd Fluticasone propionate / azelastine hydrochloride Dymista/Dylastine PM-2012-03466-1-5 New combination of active ingredients 24/07/14
Meda Pharmaceuticals Pty Ltd Azelastine hydrochloride / fluticasone propionate Dymista / Dylastine PM-2012-03466-1-5 New combination of active ingredients 24/07/14
Merck Serono Australia Pty Ltd Interferon beta-1a Rebif PM-2012-00320-3-1 Extension of indications 10/10/13
Merck Serono Australia Pty Ltd Follitropin alfa (rch) / Lutropin alfa (rch) Pergoveris PM-2008-1439-5 New fixed combination 11/01/10
Merck Serono Australia Pty Ltd Cetuximab Erbitux PM-2008-03405-3-4 Extension of indications 15/01/10
Merck Serono Australia Pty Ltd Cetuximab Erbitux PM-2009-02587-4 Extension of indications 19/10/11
Merck Serono Australia Pty Ltd Lutropin alfa (rch) / Follitropin alfa (rch) Pergoveris PM-2008-1439-5 New fixed combination 11/01/10
Merck Serono Australia Pty Ltd Cetuximab Erbitux PM-2012-00340-3-4 Major variation (review of indications, changes to Product Information) 01/10/13
Merck Serono Australia Pty Ltd Cladribine Movectro PM-2009-02909-3-1 Extension of indications, New dose form, New route of administration 06/07/11
Merck Serono Australia Pty Ltd Sapropterin dihydrochloride Kuvan PM-2009-02891-3-3 New chemical entity 21/10/10
Merck Sharp & Dohme (Australia) Pty Limited Ezetimibe / Atorvastatin Atozet / Zeteze PM-2015-04334-1-3 Extension of indications 11/07/17
Merck Sharp & Dohme (Australia) Pty Limited Ezetimibe and ezetimibe / simvastatin Ezetrol / Vytorin PM-2015-01525-1-3 Extension of indications 26/06/17
Merck Sharp & Dohme (Australia) Pty Ltd Ezetimibe and rosuvastatin (as calcium) Ezalo Composite Pack / Rosuzet Composite Pack PM-2012-03419-1-3 New combination of active ingredients 05/03/14
Merck Sharp & Dohme (Australia) Pty Ltd Rosuvastatin (as calcium) and ezetimibe Rosuzet Composite Pack / Ezalo Composite Pack PM-2012-03419-1-3 New combination of active ingredients 05/03/14
Merck Sharp & Dohme (Australia) Pty Ltd Tafluprost/Timolol Taptiqom 15/5 PM-2013-03652-1-5 New fixed dose combination 28/07/15
Merck Sharp & Dohme (Australia) Pty Ltd Amlodipine (as besilate) / Hydrochlorothiazide / Olmesartan medoxomil Sevikar HCT PM-2012-01550-3-3 New fixed dose combination 18/11/13
Merck Sharp & Dohme (Australia) Pty Ltd Timolol/Tafluprost Taptiqom 15/5 PM-2013-03652-1-5 New fixed dose combination 28/07/15
Merck Sharp & Dohme (Australia) Pty Ltd Hydrochlorothiazide / Olmesartan medoxomil / Amlodipine (as besilate) Sevikar HCT PM-2012-01550-3-3 New fixed dose combination 18/11/13
Merck Sharp & Dohme (Australia) Pty Ltd Olmesartan medoxomil / Amlodipine (as besilate) / Hydrochlorothiazide Sevikar HCT PM-2012-01550-3-3 New fixed dose combination 18/11/13
Merck Sharp & Dohme (Australia) Pty Ltd Human papillomavirus quadrivalent vaccine Gardasil PM-2009-00914-2 Extension of indications 08/10/10
Merck Sharp & Dohme (Australia) Pty Ltd Olmesartan medoxomil Olmetec PM-2011-01941-3-3 Major variation (new dosage form, increase in patient group) 26/02/13
Merck Sharp & Dohme (Australia) Pty Ltd Ivermectin Stromectol PM-2012-01113-3-2 Extension of indications 30/10/13
Merck Sharp & Dohme (Australia) Pty Ltd Simvastatin / Ezetimibe Vytorin PM-2011-01219-3-1 Extension of indications 28/02/13
Merck Sharp & Dohme (Australia) Pty Ltd Human papillomavirus (Types 6, 11, 16 & 18) quadrivalent recombinant vaccine Gardasil PM-2010-03191-3-2 Extension of indications 07/05/12
Merck Sharp & Dohme (Australia) Pty Ltd Aprepitant Emend PM-2011-00237-3-4 Major variation (new dosage regimen, new dosage) 12/11/12
Merck Sharp & Dohme (Australia) Pty Ltd Pembrolizumab (rch) Keytruda PM-2014-01928-1-4 New biological chemical entity 14/10/16
Merck Sharp & Dohme (Australia) Pty Ltd Ezetimibe / Rosuvastatin (as calcium) Ezalo, Rosuzet PM-2013-02434-1-3 New fixed dose combination 29/01/15
Merck Sharp & Dohme (Australia) Pty Ltd Sitagliptin / Metformin Janumet PM-2011-01226-3-5 Extension of indications 14/01/13
Merck Sharp & Dohme (Australia) Pty Ltd Nomegestrol acetate / Oestradiol Zoely PM-2010-00254-3-5 New chemical entity 04/10/11
Merck Sharp & Dohme (Australia) Pty Ltd Boceprevir Victrelis PM-2010-03273-3-2 New chemical entity 23/04/12
Merck Sharp & Dohme (Australia) Pty Ltd Raltegravir Isentress PM-2011-03107-3-2 New dosage form 03/06/13
Merck Sharp & Dohme (Australia) Pty Ltd Ezetimibe / Rosuvastatin (as calcium) Rosuzet, Ezalo PM-2013-02434-1-3 New fixed dose combination 29/01/15
Merck Sharp & Dohme (Australia) Pty Ltd Metformin / Sitagliptin Janumet PM-2011-01226-3-5 Extension of indications 14/01/13
Merck Sharp & Dohme (Australia) Pty Ltd Rosuvastatin (as calcium) / Ezetimibe Ezalo, Rosuzet PM-2013-02434-1-3 New fixed dose combination 29/01/15
Merck Sharp & Dohme (Australia) Pty Ltd Vernakalant Brinavess PM-2010-01025-3-3 New chemical entity 12/11/12
Merck Sharp & Dohme (Australia) Pty Ltd Sitagliptin / Simvastatin Juvicor / Xelezor / Tesozor PM-2011-02796-3-5 New fixed combination 06/06/13
Merck Sharp & Dohme (Australia) Pty Ltd Rosuvastatin (as calcium) / Ezetimibe Rosuzet, Ezalo PM-2013-02434-1-3 New fixed dose combination 29/01/15
Merck Sharp & Dohme (Australia) Pty Ltd Sitagliptin / Simvastatin Tesozor / Juvicor / Xelezor PM-2011-02796-3-5 New fixed combination 06/06/13
Merck Sharp & Dohme (Australia) Pty Ltd Ezetimibe + atorvastatin as calcium Atozet Composite Pack/Zeteze Composite Pack PM-2011-04091-3-3 New fixed dose combination 28/05/13
Merck Sharp & Dohme (Australia) Pty Ltd Sitagliptin / Simvastatin Xelezor / Tesozor / Juvicor PM-2011-02796-3-5 New fixed combination 06/06/13
Merck Sharp & Dohme (Australia) Pty Ltd Ezetimibe + atorvastatin as calcium Zeteze Composite Pack/Atozet Composite Pack PM-2011-04091-3-3 New fixed dose combination 28/05/13
Merck Sharp & Dohme (Australia) Pty Ltd Oestradiol / Nomegestrol acetate Zoely PM-2010-00254-3-5 New chemical entity 04/10/11
Merck Sharp & Dohme (Australia) Pty Ltd Tafluprost Saflutan PM-2009-3896-5 New chemical entity 03/05/12
Merck Sharp & Dohme (Australia) Pty Ltd Ezetimibe Ezetrol PM-2011-01220-3-3 Extension of indications 28/02/13
Merck Sharp & Dohme (Australia) Pty Ltd Ezetimibe/ Simvastatin Vytorin PM-2011-01219-3-1 Extension of indications 28/02/13
Merck Sharp & Dohme Australia Pty Ltd Ceftolozane (as sulfate) / Tazobactam (as sodium salt) Zerbaxa PM-2014-03153-1-2 New chemical entity 27/01/16
Merck Sharp & Dohme Australia Pty Ltd Tazobactam (as sodium salt) / Ceftolozane (as sulfate) Zerbaxa PM-2014-03153-1-2 New chemical entity 27/01/16
Merck Sharp & Dohme Australia Pty Ltd Ezetimibe / Atorvastatin Atozet, Zeteze PM-2013-03231-1-3 New combination of active ingredients 07/08/15
Merck Sharp & Dohme Australia Pty Ltd Atorvastatin / Ezetimibe Atozet, Zeteze PM-2013-03231-1-3 New combination of active ingredients 07/08/15
Merck Sharp & Dohme Australia Pty Ltd Human Papillomavirus 9 valent vaccine Gardasil 9 PM-2014-01099-1 New biological entity 03/01/17
Merck Sharp and Dohme Australia Pty Ltd Suvorexant Belsomra PM-2013-00325-1-1 New chemical entity 11/03/15
Merck Sharp and Dohme Australia Pty Ltd Grazoprevir / Elbasvir Zepatier PM-2015-02428-1-2 New chemical entity 15/05/17
Merck Sharp and Dohme Australia Pty Ltd Elbasvir / Grazoprevir Zepatier PM-2015-02428-1-2 New chemical entity 15/05/17
Merz Australia Pty Ltd Botulinum toxin type A Xeomin PM-2012-04159-1-1 10 New chemical entity 10/09/15
MS Health Mifepristone Mifepristone Linepharma PM-2010-02694-3-5 New chemical entity 02/10/12
MS Health Misoprostol GyMiso PM-2011-01625-3-5 Extension of indications 02/10/12
MS Health Pty Ltd Mifepristone / misoprostol MS-2 Step PM-2013-01037-1-5 New combination of active ingredients 13/10/14
MS Health Pty Ltd Misoprostol / mifepristone MS-2 Step PM-2013-01037-1-5 New combination of active ingredients 13/10/14
MSD (Australia) Pty Limited Sitagliptin (as phosphate monohydrate) Januvia PM 2011-01224-3-5 Extension of indications 20/12/12
Mundipharma Pty Ltd Naloxone hydrochloride / Oxycodone hydrochloride Targin PM-2008-2938-1 New fixed combination 04/05/10
Mundipharma Pty Ltd Pralatrexate Folotyn PM-2011-03153-3-4 New chemical entity 22/08/13
Mundipharma Pty Ltd Prednisone Lodotra PM 2011-00520-3-3 Major variation (new dosage form) 13/06/13
Mundipharma Pty Ltd Buprenorphine Transtec PM-2014-03891-1-1 Major variation (new indication, dose form and dose regimen) 13/12/16
Mundipharma Pty Ltd Oxycodone / Naloxone Targin PM-2015-1090-1-1 Extension of indications, Major variation 07/06/17
Mundipharma Pty Ltd Fluticasone propionate / Eformoterol fumarate dihydrate Flutiform PM-2010-03251-3-5 New combination of active ingredients 13/06/13
Mundipharma Pty Ltd Naloxone / Oxycodone Targin PM-2015-1090-1-1 Extension of indications, Major variation 07/06/17
Mundipharma Pty Ltd Eformoterol fumarate dihydrate / Fluticasone propionate Flutiform PM-2010-03251-3-5 New combination of active ingredients 13/06/13
Mundipharma Pty Ltd Oxycodone hydrochloride / Naloxone hydrochloride Targin PM-2008-2938-1 New fixed combination 04/05/10

N

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Norgine Pty Ltd Rifaximin Xifaxan PM-2014-00379-1-2 Extension of indications 13/10/15
Norgine Pty Ltd Rifaximin Xifaxan PM-2011-00501-3-1 New chemical entity 19/11/12
Novartis Australia Pty Ltd Zoledronic acid Aclasta / Osteovan PM-2010-01920-3-5 Major variation 31/08/11
Novartis Australia Pty Ltd Omalizumab (rch) Xolair PM-2014-03868-1-5 Extension of indications 22/06/16
Novartis Australia Pty Ltd Zoledronic acid Osteovan / Aclasta PM-2010-01920-3-5 Major variation 31/08/11
Novartis Australia Pty Ltd Ruxolitinib Jakavi PM-2012-01504-3-4 New chemical entity 21/01/14
Novartis Pharmaceutical Australia Pty Ltd Secukinumab Cosentyx / Zafrez PM-2013-04153-1-4 New chemical entity 16/09/15
Novartis Pharmaceutical Australia Pty Ltd Secukinumab Zafrez / Cosentyx PM-2013-04153-1-4 New chemical entity 16/09/15
Novartis Pharmaceuticals Australia Pty Limited Mycophenolate sodium Myfortic PM-2010-01235-3-2 Major variation (extension of indications) 17/05/13
Novartis Pharmaceuticals Australia Pty Limited Aliskiren (as hemifumarate) / Hydrochlorothiazide Rasilez HCT / Enviage HCT PM-2008-2072-3 New fixed combination 12/03/10
Novartis Pharmaceuticals Australia Pty Limited Imatinib (as mesylate) Glivec PM-2011-02797-3-4 Major variation (extension of duration of treatment) 04/06/13
Novartis Pharmaceuticals Australia Pty Limited Nabiximols Sativex PM-2011-00150-3-1 New chemical entity 27/09/13
Novartis Pharmaceuticals Australia Pty Limited Aliskiren / Amlodipine Rasilamlo PM-2010-00719-3-3 New fixed combination 05/08/11
Novartis Pharmaceuticals Australia Pty Limited Imatinib Glivec PM-2012-02722-3-4 Extension of indications 22/01/14
Novartis Pharmaceuticals Australia Pty Limited Amlodipine (as besylate) / Valsartan / Hydrochlorothiazide Ejocia HCT / Exforge HCT PM-2008-03499-3-3 New fixed combination 26/08/10
Novartis Pharmaceuticals Australia Pty Limited Aliskiren / Amlodipine / Hydrochlorothiazide Rasilamlo HCT PM-2010-02677-3-3 New combination of active ingredients 15/06/12
Novartis Pharmaceuticals Australia Pty Limited Fingolimod Filosir / Fynefta / Gilenya PM-2010-00401-3-1 New chemical entity 29/03/11
Novartis Pharmaceuticals Australia Pty Limited Amlodipine (as besylate) / Valsartan / Hydrochlorothiazide Exforge HCT / Ejocia HCT PM-2008-03499-3-3 New fixed combination 26/08/10
Novartis Pharmaceuticals Australia Pty Limited Fingolimod Fynefta / Filosir / Gilenya PM-2010-00401-3-1 New chemical entity 29/03/11
Novartis Pharmaceuticals Australia Pty Limited Valsartan / Amlodipine Exforge/Ejocia 10/320; Exforge/Ejocia 5/320 PM-2009-01168-3-3 Major variation (new strength) 26/07/10
Novartis Pharmaceuticals Australia Pty Limited Fingolimod Gilenya / Fynefta/ Filosir PM-2010-00401-3-1 New chemical entity 29/03/11
Novartis Pharmaceuticals Australia Pty Limited Tobramycin inhalation powder TOBI Podhaler PM-2011-00135-3-2 New dosage form 26/10/12
Novartis Pharmaceuticals Australia Pty Limited Deferasirox Exjade PM-2012-03063-1-4 Extension of indications 06/03/14
Novartis Pharmaceuticals Australia Pty Limited Valsartan / Amlodipine (as besylate) / Hydrochlorothiazide Exforge HCT / Ejocia HCT PM-2008-03499-3-3 New fixed combination 26/08/10
Novartis Pharmaceuticals Australia Pty Limited Indacaterol Arbeela Breezhaler / Onbrez Breezhaler PM-2009-00350-3-5 New chemical entity 27/10/10
Novartis Pharmaceuticals Australia Pty Limited Pasireotide (as diaspartate) Signifor PM-2014-02743-3-5 New chemical entity 27/03/14
Novartis Pharmaceuticals Australia Pty Limited Everolimus Afinitor PM-2011-01215-3-4 Extension of indications 26/02/13
Novartis Pharmaceuticals Australia Pty Limited Nilotinib Tasigna PM-2010-01053-3-4 Extension of indications, New strength 04/10/11
Novartis Pharmaceuticals Australia Pty Limited Indacaterol Onbrez Breezhaler / Arbeela Breezhaler PM-2009-00350-3-5 New chemical entity 27/10/10
Novartis Pharmaceuticals Australia Pty Limited Metformin hydrochloride / Vildagliptin Galvumet / Sobrea PM-2009-00972-3-5 New fixed combination 07/12/10
Novartis Pharmaceuticals Australia Pty Limited Everolimus Certican PM-2011-03534-3-2 Extension of indications, New dosage recommendations, Changes to Product Information 21/05/13
Novartis Pharmaceuticals Australia Pty Limited Everolimus Afinitor PM-2012-00337-3-4 Extension of indications 22/08/13
Novartis Pharmaceuticals Australia Pty Limited Glycopyrronium (as bromide) Seebri Breezhaler / Tovanor Breezhaler PM-2011-02800-3-5 New chemical entity 10/07/13
Novartis Pharmaceuticals Australia Pty Limited Hydrochlorothiazide / Aliskiren (as hemifumarate) Rasilez HCT / Enviage HCT PM-2008-2072-3 New fixed combination 12/03/10
Novartis Pharmaceuticals Australia Pty Limited Ranibizumab Lucentis PM-2010-02527-3-5 Extension of indications 09/11/11
Novartis Pharmaceuticals Australia Pty Limited Glycopyrronium (as bromide) Tovanor Breezhaler/Seebri Breezhaler PM-2011-02800-3-5 New chemical entity 10/07/13
Novartis Pharmaceuticals Australia Pty Limited Hydrochlorothiazide / Valsartan / Amlodipine (as besylate) Exforge HCT / Ejocia HCT PM-2008-03499-3-3 New fixed combination 26/08/10
Novartis Pharmaceuticals Australia Pty Limited Ranibizumab Lucentis PM-2010-03258-3-5 Extension of indications, Changes to Product Information 01/12/11
Novartis Pharmaceuticals Australia Pty Limited Vildagliptin Galvus / Xiliarx PM-2009-00158-3-5 New chemical entity 23/02/10
Novartis Pharmaceuticals Australia Pty Limited Octreotide Sandostatin LAR PM-2010-03092-3-4 Extension of indications 14/02/12
Novartis Pharmaceuticals Australia Pty Limited Hydrochlorothiazide / Aliskiren / Amlodipine Rasilamlo HCT PM-2010-02677-3-3 New combination of active ingredients 15/06/12
Novartis Pharmaceuticals Australia Pty Limited Amlodipine / Valsartan Exforge/Ejocia 5/320 / Exforge/Ejocia 10/320 PM-2009-01168-3-3 Major variation (new strength) 26/07/10
Novartis Pharmaceuticals Australia Pty Limited Vildagliptin Xiliarx / Galvus PM-2009-00158-3-5 New chemical entity 23/02/10
Novartis Pharmaceuticals Australia Pty Limited Vildagliptin / Metformin hydrochloride Galvumet / Sobrea PM-2009-00972-3-5 New fixed combination 07/12/10
Novartis Pharmaceuticals Australia Pty Limited Amlodipine / Aliskiren Rasilamlo PM-2010-00719-3-3 New fixed combination 05/08/11
Novartis Pharmaceuticals Australia Pty Limited Vildagliptin / Metformin hydrochloride Sobrea / Galvumet PM-2009-00972-3-5 New fixed combination 07/12/10
Novartis Pharmaceuticals Australia Pty Limited Aliskiren (as hemifumarate) / Hydrochlorothiazide Enviage HCT / Rasilez HCT PM-2008-2072-3 New fixed combination 12/03/10
Novartis Pharmaceuticals Australia Pty Limited Amlodipine / Aliskiren / Hydrochlorothiazide Rasilamlo HCT PM-2010-02677-3-3 New combination of active ingredients 15/06/12
Novartis Pharmaceuticals Australia Pty Ltd Ranibizumab Lucentis PM-2013-00985-1-5 Extension of indications 14/10/14
Novartis Pharmaceuticals Australia Pty Ltd Secukinumab Cosentyx / Zafrez PM-2015-00766-1-3 / 2015-00777-1-3 Extension of indications 25/10/16
Novartis Pharmaceuticals Australia Pty Ltd Secukinumab Zafrez / Cosentyx PM-2015-00766-1-3 / 2015-00777-1-3 Extension of indications 25/10/16
Novartis Pharmaceuticals Australia Pty Ltd Indacaterol maleate / Glycopyrronium bromide Ultibro Breezhaler 110/50 PM-2012-04395-1-5 New combination of active ingredients 23/10/14
Novartis Pharmaceuticals Australia Pty Ltd Sacubitril / Valsartan salt complex Entresto / Novartis sacubitril/valsartan PM-2015-00001-1-3 New combination product 23/09/16
Novartis Pharmaceuticals Australia Pty Ltd Valsartan salt complex / Sacubitril Entresto / Novartis sacubitril/valsartan PM-2015-00001-1-3 New combination product 23/09/16
Novartis Pharmaceuticals Australia Pty Ltd Canakinumab Ilaris PM-2013-01501-1-3 Extension of indications 25/11/14
Novartis Pharmaceuticals Australia Pty Ltd Glycopyrronium bromide / Indacaterol maleate Ultibro Breezhaler 110/50 PM-2012-04395-1-5 New combination of active ingredients 23/10/14
Novartis Pharmaceuticals Australia Pty Ltd Eltrombopag Revolade PM-2014-04303-1-4 Extension of indications 30/03/16
Novartis Pharmaceuticals Pty Ltd Omalizumab (rch) Xolair PM-2013-03254-1-4 Major variation (extension of indications) 21/07/15
Novartis Vaccines & Diagnostics Pty Ltd Inactivated influenza virus vaccine (containing 15 μg haemagglutinin of virus Types A H1N1+ A H3N2 + B) Optaflu PM-2013-04969-1-2 New chemical entity 24/08/15
Novartis Vaccines and Diagnostics Pty Ltd Trivalent seasonal influenza vaccine, inactivated / MF59C.1 adjuvanted Fluad Paediatric PM-2010-03905-3-2 New biological entity 04/10/12
Novartis Vaccines and Diagnostics Pty Ltd MF59C.1 adjuvanted / Trivalent seasonal influenza vaccine, inactivated Fluad Paediatric PM-2010-03905-3-2 New biological entity 04/10/12
Novartis Vaccines and Diagnostics Pty Ltd Multi-Component Meningococcal B vaccine Bexsero PM-2011-02486-3-2 New chemical entity 31/10/13
Novartis Vaccines and Diagnostics Pty Ltd Meningococcal conjugated vaccine Menveo SM-2009-00001-3-2 New chemical entity 20/05/10
Novartis Vaccines and Diagnostics Pty Ltd Influenza Virus Haemagglutinin H5N1 Aflunov / Prepandemic H5N1 adjuvanted Influenza Vaccine PM-2009-03929-3-2 New biosimilar medicine similar to other pandemic and seasonal influenza vaccines 06/07/11
Novartis Vaccines and Diagnostics Pty Ltd Influenza Virus Haemagglutinin H5N1 Prepandemic H5N1 adjuvanted Influenza Vaccine / Aflunov PM-2009-03929-3-2 New biosimilar medicine similar to other pandemic and seasonal influenza vaccines 06/07/11
Novo Nordisk Pharmaceuticals Pty Ltd Turoctocog alfa (rch) NovoEight PM-2012-03754-1-4 New chemical entity 07/05/14
Novo Nordisk Pharmaceuticals Pty Ltd Liraglutide (rys) Victoza PM-2008-2113-5 New biological entity 22/11/10
Novo Nordisk Pharmaceuticals Pty Ltd Catridecacog (rys) NovoThirteen PM-2012-02713-3-4 New chemical (biological) entity 10/04/14
Novo Nordisk Pharmaceuticals Pty Ltd Liraglutide Saxenda PM-2014-01472-1-5 Extension of indications 23/03/16
Novo Nordisk Pharmaceuticals Pty Ltd Norethisterone acetate / Oestradiol Kliovance Low PM-2010-00087-5-3 New strength 18/01/12
Novo Nordisk Pharmaceuticals Pty Ltd Oestradiol / Norethisterone acetate Kliovance Low PM-2010-00087-5-3 New strength 18/01/12
Novo Nordisk Pharmaceuticals Pty Ltd Insulin detemir (rys) Levemir PM-2012-02256-3-5 Major variation (change in patient group/pregnancy category) 28/03/14
Nycomed Pty Ltd Human Fibrinogen / Human Thrombin TachoSil PM-2010-02840-3-4 New fixed combination 31/08/12
Nycomed Pty Ltd Human Thrombin / Human Fibrinogen TachoSil PM-2010-02840-3-4 New fixed combination 31/08/12
Nycomed Pty Ltd Roflumilast Dalveza / Daxas / Xevex PM-2009-02915-3-5 New chemical entity 20/12/11
Nycomed Pty Ltd Roflumilast Daxas / Xevex / Dalveza PM-2009-02915-3-5 New chemical entity 20/12/11
Nycomed Pty Ltd Roflumilast Xevex / Daxas / Dalveza PM-2009-02915-3-5 New chemical entity 20/12/11
Nycomed Pty Ltd Ciclesonide Omnaris PM-2009-03337-3-5 Extension of indications, New dose form, New route of administration 18/01/12

O

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Octapharma Australia Pty Ltd Simoctocog alfa rhu Nuwiq PM-2013-02226-1-4 New biological entity 07/06/16
Orphan Australia Pty Ltd Ursodeoxycholic acid Urso / Ursofalk PM-2008-03582-3-1 Extension of indications, Change of dosage 28/07/10
Orphan Australia Pty Ltd Fentanyl citrate Fentora PM-2013-03632-1-1 New dose form, New route of administration 22/04/15
Orphan Australia Pty Ltd Anagrelide hydrochloride Thromboreductin PM-2009-03102-3-4 Orphan drug 07/05/12
Orphan Australia Pty Ltd Budesonide Budenofalk PM-2010-03268-3-1 Major variation (new dose form, new indications) 22/10/12
Orphan Australia Pty Ltd Deferiprone Ferriprox PM-2010-00539-3-4 Extension of indications, Increase in dosage, Changes to Product Information 04/10/11
Orphan Australia Pty Ltd Nitisinone Orfadin PM-2009-02266-3-3 New chemical entity 15/10/10
Orphan Australia Pty Ltd Tolvaptan Samsca PM-2010-02939-3-5 New chemical entity 04/10/12

P

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Pfizer Australia Pty Ltd Tofacitinib (as citrate) Xeljanz PM-2012-00788-3-3 New chemical entity 06/03/15
Pfizer Australia Pty Ltd Pneumococcal Polysaccharide Conjugate Vaccine 13 valent Prevenar 13 PM-2010-03262-3-2 Extension of indications, Changes to Product Information 13/12/11
Pfizer Australia Pty Ltd Somatropin Genotropin PM-2008-2730-5 Product information change 09/03/10
Pfizer Australia Pty Ltd Etanercept Enbrel PM-2013-04552-1-3 Extension of indications 23/09/15
Pfizer Australia Pty Ltd Docetaxel Docetaxel-PF PM-2011-01623-3-4 New generic 13/05/13
Pfizer Australia Pty Ltd Voriconazole Vfend PM-2011-03524-3-2 Extension of indications 21/05/13
Pfizer Australia Pty Ltd Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed Prevenar 13 PM-2012-02211-3-2 Extension of indications, Changes to Product Information 07/02/14
Pfizer Australia Pty Ltd Ziprasidone mesilate Zeldox IM PM-2008-1737-1 New dosage form 18/12/09
Pfizer Australia Pty Ltd Taliglucerase alfa rpc Elelyso PM-2013-00303-1-3 New biological entity 14/10/14
Pfizer Australia Pty Ltd Sildenafil Revatio PM-2010-00912-3-3 Extension of indications, Major variation 12/10/11
Pfizer Australia Pty Ltd Etanercept Enbrel PM-2010-03845-3-4 Extension of indications 19/03/12
Pfizer Australia Pty Ltd Sildenafil Revatio PM-2010-00820-3-3 Extension of indications 19/10/11
Pfizer Australia Pty Ltd Etanercept (rch) Enbrel PM-2012-04135-1-3 Extension of indications 24/03/14
Pfizer Australia Pty Ltd Crizotinib Xalkori PM-2011-02752-3-4 New chemical entity 12/03/14
Pfizer Australia Pty Ltd Celecoxib Celebrex PM-2009-01564-3-1 Extension of indications 23/06/10
Pfizer Australia Pty Ltd Sunitinib Sutent PM-2010-01205-4 Extension of indications, New dosage 29/06/11
Pfizer Australia Pty Ltd Dalteparin Fragmin PM-2009-00586-3-3 Extension of indications 27/05/10
Pfizer Australia Pty Ltd Tranexamic acid Cyklokapron PM-2009-00587 Extension of indications, New dosage form 10/09/10
Pfizer Australia Pty Ltd Eplerenone Inspra PM-2011-04066-3-3 Extension of indications 01/10/13
Pfizer Australia Pty Ltd Axitinib Inlyta PM-2011-00876-3-4 New chemical entity 12/02/13
Pfizer Australia Pty Ltd Medroxyprogesterone acetate Sayana PM-2009-03498-3-5 Major variation (route of administration) 27/07/11
Pfizer Australia Pty Ltd Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed Prevenar 13 PM-2013-01480-1-3 Extension of indications 17/09/14
Pharmaxis Ltd Mannitol Bronchitol PM-2009-03748-3-5 Extension of indications 29/03/11
Phebra Pty Ltd Colistimethate sodium Tadim PM-2009-02764-3-2 New dose form, New route of administration 13/01/11
Phebra Pty Ltd Arsenic trioxide Phenasen PM-2014-02385-1-4 Extension of indications 16/12/15
Phebra Pty Ltd Caffeine citrate Cafnea PM-2008-2175-5 New chemical entity 17/03/10
Phebra Pty Ltd Ibuprofen Caldolor PM-2010-02393-3-1 Major variation (new dosage form, new route of administration) 02/01/13
Phebra Pty Ltd Digoxin-specific antibody fragment F(Ab) (Ovine) DigiFab PM-2012-03387-1-3 New biological entity 05/05/14
Pierre Fabre Australia Pty Ltd Levomilnacipran (as hydrochloride) Fetzima PM-2014-04276-1-1 New chemical entity 13/12/16
Pierre Fabre Medicament Australia Pty Ltd Vinorelbine Navelbine PM-2010-03252-3-4 Extension of indications 30/05/12
Pierre Fabre Medicament Australia Pty Ltd Milnacipran hydrochloride Joncia PM-2011-02708-3-1 New chemical entity 24/01/12
Pierre Fabre Medicament Australia Pty Ltd Vinflunine ditartrate Javlor PM-2009-03102-3-4 New chemical entity 07/02/11

R

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
RAD Data Australia Pty Ltd Melatonin Circadin PM-2010-01756-3-1 Extension of indications 18/01/11
Reckitt Benckiser (Australia) Pty Ltd Naloxone / Buprenorphine Suboxone Sublingual Film PM-2009-01902-3-1 New dose form 07/12/10
Reckitt Benckiser (Australia) Pty Ltd Buprenorphine / Naloxone Suboxone Sublingual Film PM-2009-01902-3-1 New dose form 07/12/10
Roche Australia Pty Ltd Ribavirin / Peginterferon alfa-2a Pegasys RBV / Pegasys / Copegus PM-2010-00382/00415/00416-3-2 Major variation 15/06/11
Roche Australia Pty Ltd Peginterferon alfa-2a / Ribavirin Copegus / Pegasys RBV / Pegasys PM-2010-00382/00415/00416-3-2 Major variation 15/06/11
Roche Australia Pty Ltd Peginterferon alfa-2a / Ribavirin Pegasys RBV / Pegasys / Copegus PM-2010-00382/00415/00416-3-2 Major variation 15/06/11
Roche Products Australia Pty Ltd Bevacizumab Avastin PM-2013-00709-1-4 Major variation (extension of indications) 03/11/14
Roche Products Pty Limited Rituximab MabThera SC PM-2012-04453-1-4 New dose form 04/09/14
Roche Products Pty Limited Pertuzumab Perjeta PM-2014-04259-1-4 Extension of indications 16/06/16
Roche Products Pty Ltd Rituximab MabThera PM-2010-01845-3-4 New dosage regimen 09/12/11
Roche Products Pty Ltd Vismodegib Erivedge PM-2012-00329-3-4 New chemical entity 13/09/13
Roche Products Pty Ltd Erlotinib Tarceva PM-2009-00835-3-4 Extension of indications 09/11/10
Roche Products Pty Ltd Rituximab MabThera PM-2012-00331-3-3 Extension of indications 13/08/13
Roche Products Pty Ltd Rituximab MabThera PM-2014-04709-1-4 Major variation 09/02/17
Roche Products Pty Ltd Erlotinib Tarceva PM-2011-01993-3-4 Extension of indications 07/01/13
Roche Products Pty Ltd Obinutuzumab Gazyva PM-2013-01148-1-4 New biological entity 26/08/14
Roche Products Pty Ltd Trastuzumab Herceptin PM-2013-04600-1-4 New route of administration 03/08/15
Roche Products Pty Ltd Tocilizumab (rch) Actemra PM-2013-02398-1-3 Major variation (extension of indications) 13/01/15
Roche Products Pty Ltd Tocilizumab (rch) Actemra PM-2014-04309-1-3 Major variation (new dosage form, new dose, new strength and new route of administration) 29/09/16
Roche Products Pty Ltd Bevacizumab Avastin PM-2009-00515-3-1 Extension of indications 14/12/09
Roche Products Pty Ltd Bevacizumab (rch) Avastin PM-2014-01871-1-4 Major variation (new indication) 10/05/17
Roche Products Pty Ltd Bevacizumab Avastin PM-2010-3786-3-4 Extension of indications 06/08/12
Roche Products Pty Ltd Tocilizumab Actemra PM-2009-03295-3-3 Extension of indications 13/01/11
Roche Products Pty Ltd Bevacizumab (recombinant humanised) Avastin PM-2011-02308-3-4 Extension of indications 07/03/13
Roche Products Pty Ltd Tocilizumab Actemra PM-2010-03070-3-3 Extension of indications 06/12/11
Roche Products Pty Ltd Bevacizumab injection Avastin PM-2012-02716-3-4 Major variation (dosage) 31/03/14
Roche Products Pty Ltd Tocilizumab Actemra PM-2012-01905-3-3 Extension of indications 06/02/14
Roche Products Pty Ltd Oseltamivir phosphate Tamiflu PM-2010-00616-3-2 Major variation (extension of indications/new population) 27/07/11
Roche Products Pty Ltd Vemurafenib Zelboraf PM-2011-00795-3-4 New chemical entity 17/12/12
Roche Products Pty Ltd Pertuzumab (rch) Perjeta PM-2012-00311-3-4 New biological entity 01/10/13
Roche Products Pty Ltd Valganciclovir Valcyte PM-2014-01870-1-2 Major variation (dosage) 05/01/16
Roche Products Pty Ltd Pirfenidone Esbriet PM-2015-00413-1-5 New chemical entity 09/08/16
Roche Products Pty Ltd Trastuzumab Herceptin PM-2009-03121 Major variation (extension of indications) 17/09/10
Roche Products Pty Ltd Rituximab MabThera PM-2009-00656-3-4 Extension of indications 19/02/10
Roche Products Pty Ltd Trastuzumab emtansine Kadcyla PM-2012-02734-3-4 New chemical entity 17/03/14
Roche Products Pty Ltd Trastuzumab Herceptin 2011-01528-3-4 Extension of indications 17/12/12
Roche Products Pty Ltd Rituximab MabThera PM-2009-01744-3-3 Extension of indications, Broaden patient population 06/05/10
Roche Products Pty Ltd Rituximab MabThera PM-2013-04906-1-3 New dosing schedule 27/08/15
Roche Products Pty Ltd Bevacizumab Avastin PM-2013-03227-1-4 Extension of indications 11/03/15
Roche Products Pty Ltd / Sanofi-Aventis Australia Pty Ltd Capecitabine / Oxaliplatin Xeloda / Eloxatin / Oxaliplatin Dakota / Winthrop Oxaliplatin PM-2010-00909-4/ 2010-02795-4 Major variation (extension of indications, new dosage) 23/03/11

S

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Samsung Bioepis AU Pty Ltd Etanercept (rch) Brenzys PM-2015-01528-1-3 New biological entity 21/06/17
Sandoz Pty Ltd Filgrastim (rbe) Zarzio PM-2011-03860-3-4 New Similar Biological Medicinal Product 03/10/13
Sanofi Aventis Australia Pty Ltd Poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide / Hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid Hexaxim PM-2013-02800-1-2 New biological entity 12/01/15
Sanofi Aventis Australia Pty Ltd Tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide / Hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus Hexaxim PM-2013-02800-1-2 New biological entity 12/01/15
Sanofi Aventis Australia Pty Ltd Diphtheria toxoid / Haemophilus type B polysaccharide / hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid Hexaxim PM-2013-02800-1-2 New biological entity 12/01/15
Sanofi Aventis Australia Pty Ltd Insulin glargine (rbe) Toujeo / Edomlus / Lambeto PM-2014-00670-1-5 New strength 06/01/17
Sanofi Aventis Australia Pty Ltd Haemophilus type B polysaccharide / hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid Hexaxim PM-2013-02800-1-2 New biological entity 12/01/15
Sanofi Aventis Australia Pty Ltd Insulin glargine (rbe) Edomlus / Lambeto /Toujeo PM-2014-00670-1-5 New strength 06/01/17
Sanofi Aventis Australia Pty Ltd Hepatitis B surface antigen / pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide Hexaxim PM-2013-02800-1-2 New biological entity 12/01/15
Sanofi Aventis Australia Pty Ltd Insulin glargine (rbe) Lambeto /Toujeo / Edomlus PM-2014-00670-1-5 New strength 06/01/17
Sanofi Aventis Australia Pty Ltd Pertussis filamentous haemagglutinin / pertussis toxoid / poliovirus / tetanus protein / tetanus toxoid / Diphtheria toxoid / Haemophilus type B polysaccharide / Hepatitis B surface antigen Hexaxim PM-2013-02800-1-2 New biological entity 12/01/15
Sanofi Pasteur Pty Ltd Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine - Groups A, C, Y and W-135 Menactra PM-2010-00277-3-5 New chemical entity 31/08/11
Sanofi Pasteur Pty Ltd Japanese Encephalitis Chimeric Virus Imojev PM-2009-01554-3-2 New chemical entity 16/08/10
Sanofi-Aventis Australia Pty Ltd Sevelamer carbonate Renvela / Sevelamer Carbonate Winthrop / Sevelamer Carbonate Sanofi PM-2013-04961-1-3 New chemical entity 02/10/15
Sanofi-Aventis Australia Pty Ltd Dronedarone hydrochloride Dronedarone Winthrop / Dronedarone Sanofi / Multaq PM-2008-3045-3 New chemical entity 05/10/10
Sanofi-Aventis Australia Pty Ltd Aflibercept (rch) Aflitiv / Lidaveg / Zaltrap PM-2011-04301-3-4 New biological entity 29/07/13
Sanofi-Aventis Australia Pty Ltd Sevelamer carbonate Sevelamer Carbonate Winthrop / Sevelamer Carbonate Sanofi / Renvela PM-2013-04961-1-3 New chemical entity 02/10/15
Sanofi-Aventis Australia Pty Ltd Dronedarone hydrochloride Multaq / Dronedarone Winthrop / Dronedarone Sanofi PM-2008-3045-3 New chemical entity 05/10/10
Sanofi-Aventis Australia Pty Ltd Aflibercept (rch) Lidaveg / Zaltrap / Aflitiv PM-2011-04301-3-4 New biological entity 29/07/13
Sanofi-Aventis Australia Pty Ltd Eliglustat (as tartrate) Cerdelga / Eliglustat Genzyme PM-2013-03651-1-1 New chemical entity 05/08/15
Sanofi-Aventis Australia Pty Ltd Aflibercept (rch) Zaltrap / Aflitiv / Lidaveg PM-2011-04301-3-4 New biological entity 29/07/13
Sanofi-Aventis Australia Pty Ltd Alirocumab (rch) Praluent (Golyra/Eliriduc) PM-2015-00764-1-3 New biological entity 13/12/16
Sanofi-Aventis Australia Pty Ltd 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 PM-2011-03163-3-5 New chemical entity 20/08/13
Sanofi-Aventis Australia Pty Ltd Eliglustat (as tartrate) Eliglustat Genzyme / Cerdelga PM-2013-03651-1-1 New chemical entity 05/08/15
Sanofi-Aventis Australia Pty Ltd Cabazitaxel Jevtana PM-2010-02565-3-4 New chemical entity 09/02/12
Sanofi-Aventis Australia Pty Ltd Japanese Encephalitis Vaccine (live, attenuated) Imojev PM-2012-02264-3-2 Major variation 03/02/14
Sanofi-Aventis Australia Pty Ltd Alemtuzumab (rch) Lemtrada PM-2012-02297-3-1 New dosage strength, New patient group, New dosage regime 04/02/14
Sanofi-Aventis Australia Pty Ltd Alemtuzumab (rch) Remniq PM-2012-02297-3-1 New dosage strength, New patient group, New dosage regime 04/02/14
Sanofi-Aventis Australia Pty Ltd Teriflunomide Aubagio / Teriflunomide Winthrop / Teriflunomide Sanofi PM-2011-02772-3-1 New chemical entity 21/05/13
Sanofi-Aventis Australia Pty Ltd Influenza Virus Haemagglutinin H1N1, H3N2, B Victoria lineage, B Yamagata lineage FluQuadri, FluQuadri Junior PM-2013-02401-1-2 New biological entity 06/02/15
Sanofi-Aventis Australia Pty Ltd Teriflunomide Teriflunomide Sanofi / Aubagio / Teriflunomide Winthrop PM-2011-02772-3-1 New chemical entity 21/05/13
Sanofi-Aventis Australia Pty Ltd Teriflunomide Teriflunomide Winthrop / Aubagio / Teriflunomide Sanofi PM-2011-02772-3-1 New chemical entity 21/05/13
Sanofi-Aventis Australia Pty Ltd Clobazam Frisium PM-2011-04302-3-1 Extension of indications 03/10/13
Sanofi-Aventis Australia Pty Ltd / Bristol-Myers Squibb Australia Pty Ltd Clopidogrel / Aspirin CoPlavix / DuoCover PM-2010-00534-3-4 / 2010-00535-3-3 Extension of indications 28/07/11
Sanofi-Aventis Australia Pty Ltd / Bristol-Myers Squibb Australia Pty Ltd Aspirin / Clopidogrel CoPlavix / DuoCover PM-2010-00534-3-4 / 2010-00535-3-3 Extension of indications 28/07/11
Sanofi-Aventis Australia Pty Ltd/Roche Products Pty Ltd Oxaliplatin / Capecitabine Eloxatin / Oxaliplatin Dakota / Winthrop Oxaliplatin / Xeloda PM-2010-00909-4/ 2010-02795-4 Major variation (extension of indications, new dosage) 23/03/11
Sanofi-Aventis Australia Pty Ltd/Roche Products Pty Ltd Oxaliplatin / Capecitabine Oxaliplatin Dakota / Eloxatin / Winthrop Oxaliplatin / Xeloda PM-2010-00909-4/ 2010-02795-4 Major variation (extension of indications, new dosage) 23/03/11
Sanofi-Aventis Australia Pty Ltd/Roche Products Pty Ltd Oxaliplatin / Capecitabine Winthrop Oxaliplatin / Eloxatin / Oxaliplatin Dakota / Xeloda PM-2010-00909-4/ 2010-02795-4 Major variation (extension of indications, new dosage) 23/03/11
Schering-Plough Pty Ltd Amlodipine besylate / Olmesartan medoxomil Sevikar PM-2008-03320-3-3 New fixed dose combination 21/09/10
Schering-Plough Pty Ltd Olmesartan medoxomil / Amlodipine besylate Sevikar PM-2008-03320-3-3 New fixed dose combination 21/09/10
Schering-Plough Pty Ltd Corifollitropin alfa Elonva PM-2009-00870-3-5 New chemical entity 21/07/10
Schering-Plough Pty Ltd Asenapine Saphris PM-2009-03233-3-1 New chemical entity 07/03/11
Schering-Plough Pty Ltd Golimumab Simponi PM-2008-1811-3 New biological entity 14/12/09
SciGen Australia Pty Ltd Zonisamide Zonegran PM-2011-03861-3-1 Extension of indications 22/07/13
Seqirus Pty Ltd Inactivated quadrivalent influenza vaccine (split virion) Afluria Quad PM-2015-02796-1-2 New chemical/biological entity 20/07/17
Servier Laboratories (Aust) Pty Ltd Amlodipine (as besylate) / Perindopril arginine Coveram PM-2008-2262-3 New combination 13/11/09
Servier Laboratories (Aust) Pty Ltd Ivabradine Coralan PM-2008-2832-3 Extension of indications 03/09/10
Servier Laboratories (Aust) Pty Ltd Ivabradine Coralan PM-2010-03269-3-3 Major variation (extension of indications) 31/10/12
Servier Laboratories (Aust) Pty Ltd Strontium ranelate Protos PM-2011-00498-3-5 Extension of indications 07/01/13
Servier Laboratories (Aust) Pty Ltd Agomelatine Valdoxan PM-2009-00483-3-1 New chemical entity 21/10/10
Servier Laboratories (Aust) Pty Ltd Perindopril arginine / Amlodipine (as besylate) Coveram PM-2008-2262-3 New combination 13/11/09
Shire Australia Pty Ltd Lisdexamfetamine dimesilate Vyvanse PM-2012-01494-3-1 New chemical entity 23/10/13
Shire Australia Pty Ltd Agalsidase alfa ghu Replagal PM-2009-01140-3-3 New manufacturing process 18/06/10
Shire Australia Pty Ltd Velaglucerase alfa (ghu) VPRIV PM-2010-03810-3-3 New chemical entity (biological) 07/05/12
Shire Australia Pty Ltd Lanthanum carbonate Fosrenol PM-2010-01654-3-3 Extension of indications 14/02/12
Shire Australia Pty Ltd Icatibant Firazyr SM-2009-00755-3-2 New chemical entity 07/06/10
Specialised Therapeutics Australia Pty Ltd Palonosetron hydrochloride Aloxi PM-2012-02735-3-4 Major variation (dosage) 07/01/14
Specialised Therapeutics Australia Pty Ltd Aminolevulinic acid HCl Gliolan PM-2012-03095-1-2 New chemical entity 03/03/14
Specialised Therapeutics Australia Pty Ltd Netupitant / Palonosetron (as hydrochloride) Akynzeo PM-2014-00341-1-4 New chemical entity, New fixed dose combination 28/10/16
Specialised Therapeutics Australia Pty Ltd Palonosetron (as hydrochloride) / Netupitant Akynzeo PM-2014-00341-1-4 New chemical entity, New fixed dose combination 28/10/16
Specialised Therapeutics Australia Pty Ltd Fidaxomicin Dificid PM-2012-04269-3-2 New chemical entity 26/09/13
Stallergenes Australia Pty Ltd American house dust mite / European house dust mite Actair initiation treatment, Actair continuation treatment PM-2014-03871-1-2 Major variation (new dosage form and new route of administration) 09/08/17
Stallergenes Australia Pty Ltd European house dust mite / American house dust mite Actair initiation treatment, Actair continuation treatment PM-2014-03871-1-2 Major variation (new dosage form and new route of administration) 09/08/17

s

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
sponsor Pierre Fabre Medicament Australia Pty Ltd Propranolol hydrochloride Hemangiol PM-2013-01250-1-4 Major variation (extension of indications new dose form and strength) 19/08/15

T

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Takeda Pharmaceuticals Australia Pty Ltd Brentuximab vedotin Adcetris PM-2012-03441-1-4 New chemical entity 19/05/14
Takeda Pharmaceuticals Australia Pty Ltd Vedolizumab (rch) Entyvio / Kynteles PM-2013-01102-1-1 New biological entity 17/11/14
Takeda Pharmaceuticals Australia Pty Ltd Brentuximab vedotin Adcetris PM-2015-01529-1-4 Extension of indications 14/09/17
Takeda Pharmaceuticals Australia Pty Ltd Vedolizumab (rch) Kynteles / Entyvio PM-2013-01102-1-1 New biological entity 17/11/14
Takeda Pharmaceuticals Australia Pty Ltd Alogliptin (as benzoate) Nesina / Vipidia PM-2012-01949-3-5 New chemical entity 09/01/14
Takeda Pharmaceuticals Australia Pty Ltd Alogliptin (as benzoate) Vipidia / Nesina PM-2012-01949-3-5 New chemical entity 09/01/14
Takeda Pharmaceuticals Australia Pty Ltd Fentanyl citrate Instanyl PM-2012-00804-3-1 Major variation (new dose form) 11/11/13
Talecris Biotherapeutics Pty Ltd Immunoglobulin - normal (human) Gamunex PM-2010-01870-3 -201870-3-2 Extension of indications, New route of administration 13/12/11
Teva Pharma Australia Pty Ltd Levonorgestrel / ethinyloestradiol Seasonique PM-2015-00767-1-5 Major variation (change in dosage amount and regimen) 09/12/16
Teva Pharma Australia Pty Ltd Lipegfilgrastim (rbe) Lonquex PM- 2014-03142-1-4 New chemical entity 23/02/16
Teva Pharmaceuticals Australia Pty Ltd Armodafinil Nuvigil PM-2014-01922-1-1 New chemical entity 26/05/16

U

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
UCB Australia Pty Ltd Brivaracetam Briviact PM-2015-01568-1-1 New biological entity 07/03/17
UCB Australia Pty Ltd Certolizumab pegol Cimzia PM-2008-2508-3 New biological entity 22/12/09
UCB Australia Pty Ltd Certolizumab pegol Cimzia PM-2015-01158-1-3 Extension of indications 21/06/17
UCB Australia Pty Ltd Rotigotine Neupro PM-2009-01999-3-1 Extension of indications, New strength 08/10/10
UCB Australia Pty Ltd Certolizumab Cimzia PM-2013-00286-2-3 Extension of indications 15/08/14
UCB Australia Pty Ltd Certolizumab pegol (rbe) Cimzia PM-2013-04590-1-3 Major variation (extension of indications) 02/11/15

V

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Vertex Pharmaceuticals Australia Ivacaftor Kalydeco PM-2015-00399-1-5 Extension of indications 05/01/17
Vertex Pharmaceuticals Australia Pty Ltd Ivacaftor / Lumacaftor Orkambi 200/125 PM-2015-00424-1-5 New chemical entity in a fixed dose combination 08/09/16
Vertex Pharmaceuticals Australia Pty Ltd Lumacaftor / ivacaftor Orkambi 200/125 PM-2015-00424-1-5 New chemical entity in a fixed dose combination 08/09/16
Vertex Pharmaceuticals Australia Pty Ltd Ivacaftor Kalydeco PM-2012-01491-3-5 New chemical entity 29/11/13
Vifor Pharma Pty Ltd Sucroferric oxyhydroxide Velphoro PM-2013-03249-1-3 New chemical entity 19/02/15
Vifor Pharma Pty Ltd Ferric carboxymaltose Ferinject PM-2009-01623-3-4 New chemical entity 24/05/11
Vifor Pharma Pty Ltd Ulipristal acetate Esmya PM-2015-00776-1-5 Extension of indications 19/10/16
ViiV Healthcare Pty Ltd Dolutegravir (as sodium) Tivicay PM-2012-04124-1-2 New chemical entity 19/05/14
ViiV Healthcare Pty Ltd Dolutegravir sodium / Abacavir sulfate / Lamivudine Triumeq PM-2013-04112-1-2 New fixed dose combination 19/05/15
ViiV Healthcare Pty Ltd Abacavir sulfate / Lamivudine / Dolutegravir sodium Triumeq PM-2013-04112-1-2 New fixed dose combination 19/05/15
ViiV Healthcare Pty Ltd Lamivudine / Dolutegravir sodium / Abacavir sulfate Triumeq PM-2013-04112-1-2 New fixed dose combination 19/05/15
ViiV Healthcare Pty Ltd Maraviroc Celsentri PM-2010-02896-3-2 Major variation (extension of indications) 12/05/13

W

Sponsor Active Ingredient Product Name Submission Number Submission Type AusPAR Date
Wyeth Australia Pty Ltd Pneumococcal Polysaccharide Conjugate Vaccine Prevenar 13 PM-2009-00110-3-2 New biological entity 13/05/10
Wyeth Australia Pty Ltd Etanercept Enbrel PM-2008-03723-3-4 Extension of indications 16/02/10