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23 results
Medicine
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Periodic safety update report single assessments Remove Periodic safety update report single assessments 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: Seresto and its associated name Foresto
imidacloprid, flumethrin, associated names: Foresto, Article 13
Status: European Commission final decision, opinion/position date: 15/02/2018, EC decision date: 25/05/2018, Last updated: 10/07/2018 -
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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: Resflor solution injectable and associated names
florfenicol, flunixin, Article 13
Status: European Commission final decision, opinion/position date: 07/10/2014, EC decision date: 05/12/2014, Last updated: 09/01/2015 -
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Referral: Vasotop P
ramipril, Article 13
Status: European Commission final decision, opinion/position date: 08/12/2009, EC decision date: 27/04/2010, Last updated: 14/08/2014 -
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Referral: Cobactan DC and its associated names
cefquinome, associated names: Cephaguard DC, Cobactan DC intramam Susp. Ad us. Vet, Cobactan DC suspension intramammaire, Article 13
Status: European Commission final decision, opinion/position date: 20/07/2006, EC decision date: 13/10/2006, Last updated: 12/08/2014 -
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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: Cydectin TriclaMox
moxidectin, triclabendazole, Article 13
Status: European Commission final decision, opinion/position date: 16/07/2013, EC decision date: 25/09/2013, Last updated: 18/10/2013 -
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Referral: Soludox
doxycycline hyclate, Article 13
Status: European Commission final decision, opinion/position date: 12/06/2013, EC decision date: 12/08/2013, Last updated: 24/09/2013 -
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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: 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: 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