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26 results
Medicine
Referrals Remove Referrals filter
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
Referral type
Article 5(11) referrals (prior to January 2010) Remove Article 5(11) referrals (prior to January 2010) filter
Article 29 paediatrics Remove Article 29 paediatrics filter
Article 13 referrals Remove Article 13 referrals filter
Article 36 referrals (prior to July 2012) Remove Article 36 referrals (prior to July 2012) filter
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Referral: Basiron AC and associated names
benzoyl peroxide, Article 13 referrals
Status: European Commission final decision, opinion/position date: 28/03/2019, EC decision date: 04/07/2019, Last updated: 19/07/2019 -
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Referral: Cardioxane
dexrazoxane, Article 13 referrals
Status: European Commission final decision, opinion/position date: 19/07/2017, EC decision date: 19/07/2017, Last updated: 26/07/2017 -
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Referral: Levonelle 1500 microgram tablets and associated names
levonorgestrel, Article 13 referrals
Status: European Commission final decision, opinion/position date: 26/05/2016, EC decision date: 01/08/2016, Last updated: 09/08/2016 -
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Referral: Oxynal Targin and associated names
oxycodone hydrochloride, naloxone hydrochloride, Article 13 referrals
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 22/12/2014, Last updated: 27/01/2015 -
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Referral: Crestor and associated names
rosuvastatin, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 30/06/2014, Last updated: 01/08/2014 -
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Referral: Vivaglobin
human normal immunoglobulin, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 16/02/2012, EC decision date: 07/05/2012, Last updated: 18/11/2013 -
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Referral: Kantos Master
beclometasone dipropionate, formoterol fumarate, associated names: Kantos, Formodual, Foster, Inuxair, Innovair and associated names, Article 13 referrals
Status: European Commission final decision, opinion/position date: 17/01/2013, EC decision date: 10/04/2013, Last updated: 02/05/2013 -
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Referral: Preflucel
influenza vaccine, purified antigen, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 10/12/2012, Last updated: 20/07/2012 -
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Referral: Norditropin
somatropin, associated names: Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx, Article 13 referrals
Status: European Commission final decision, opinion/position date: 15/12/2011, EC decision date: 06/03/2012, Last updated: 19/04/2012 -
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Referral: Novimp
goserelin, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 16/09/2011, Last updated: 06/02/2012 -
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Referral: Goserelin Cell Pharm
goserelin, associated names: Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 16/09/2011, Last updated: 06/02/2012 -
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Referral: Novosis Goserelin
goserelin, associated names: Goserelin Novosis, Gosacin, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 16/09/2011, Last updated: 06/02/2012 -
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Referral: Cozaar
irbesartan, associated names: Loortan, Loortan Cardio Start, Cozaar Startpakkle, Cardopal Start, Lorzaar, Lorzaar start, Lorzaar Protect, Pinzaar, Lorzaar Varipharmstart, Lortaan, Neo-Lotan, Losaprex, Cozaar IC, Lortaar IC, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 23/10/2008, EC decision date: 22/01/2009, Last updated: 13/01/2012 -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011 -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011 -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011 -
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Referral: Xalatan
latanoprost, associated names: Latanoprost Pharmacia & Upjohn, Xalatan 50 mikrogramov/ml kaplijice za oko, raztopina, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 22/07/2010, EC decision date: 15/10/2010, Last updated: 08/12/2010 -
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Referral: Diovan
valsartan, associated names: Angiosan, Diovane, Tareg, Cordinate, Provas, Dalzad, Rixil, Kalpress Cardio, Diovan Cardio, Miten Cardio, Valsartan Novartis, Kalpress, Miten, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 15/12/2009, EC decision date: 19/04/2010, Last updated: 31/05/2010 -
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Referral: Diovan
valsartan, associated names: Angiosan, Diovane, Tareg, Cordinate, Provas, Dalzad, Rixil, Kalpress Cardio, Diovan Cardio, Miten Cardio, Valsartan Novartis, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 15/12/2009, EC decision date: 19/04/2010, Last updated: 31/05/2010 -
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Referral: Arimidex
anastrozole, Article 29 paediatrics
Status: European Commission final decision, EC decision date: 06/11/2009, Last updated: 28/05/2010 -
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Referral: Belanette
drospirenone, ethinyl estradiol, Article 5(11) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 14/12/2007, EC decision date: 17/06/2008, Last updated: 03/07/2008 -
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Referral: Yasminelle
drospirenone, ethinylestradiol, Article 5(11) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 14/12/2007, EC decision date: 17/06/2008, Last updated: 03/07/2008 -
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Referral: Gadograf, Gadovist
gadobutrol, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 17/11/2006, EC decision date: 13/04/2007, Last updated: 09/11/2007 -
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Referral: Cerivastatin
cerivastatin, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 21/03/2002, EC decision date: 22/08/2002, Last updated: 20/12/2002 -
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Referral: Bupropion hydrochloride
bupropion, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 25/07/2002, EC decision date: 25/10/2002, Last updated: 06/12/2002