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69 results
Medicine
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Referral: Methotrexate containing medicinal products
methotrexate, associated names: Nordimet, Jylamvo, Ledertrexate, Maxtrex, Metex, Metoject, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/08/2019, EC decision date: 21/10/2019, Last updated: 31/10/2019 -
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Referral: Lartruvo
olaratumab, associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019 -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan and olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 02/04/2019, Last updated: 20/08/2019 -
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Referral: Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction
Omega-3 fatty acid ethyl esters, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2018, EC decision date: 06/06/2019, Last updated: 13/06/2019 -
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Referral: Metamizole containing medicinal products
metamizole, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2018, EC decision date: 20/03/2019, Last updated: 28/03/2019 -
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Referral: Quinolone- and fluoroquinolone-containing medicinal products
nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin, associated names: Quinsair, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 11/03/2019, Last updated: 19/03/2019 -
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Referral: Dienogest/ethinylestradiol-containing medicinal products indicated in acne
dienogest / ethinylestradiol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/01/2017, EC decision date: 22/03/2017, -
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Referral: Linoladiol N and Linoladiol HN
estradiol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/04/2014, EC decision date: 19/08/2014, -
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Referral: Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines
Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines, associated names: Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R. Vax, Rouvax, Trivivac, Varilrix, Varivax, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2012, EC decision date: 27/06/2013, Last updated: 12/03/2014 -
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Referral: Baxter dialysis solutions
Baxter dialysis solutions, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/10/2011, EC decision date: 16/12/2011, -
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Referral: Octagam
human normal immunoglobulin, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 23/09/2010, EC decision date: 04/10/2010, -
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Referral: Antifibrinolytic medicines
aprotinin, aminocaproic acid, tranexamic acid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/06/2012, -
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Referral: Calcitonin
calcitonin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 13/02/2013, -
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Referral: Tolperisone
Tolperisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/10/2012, EC decision date: 21/01/2013, -
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Referral: Orlistat
orlistat, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/02/2012, EC decision date: 24/04/2012, -
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Referral: Trimetazidine
Trimetazidine, associated names: Vastarel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/06/2012, EC decision date: 03/09/2012, -
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Referral: Buflomedil
buflomedil, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 17/11/2011, EC decision date: 13/02/2012, -
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Referral: Meprobamate
meprobamate, associated names: Equanil and other trade names, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 19/01/2012, EC decision date: 30/03/2012, -
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Referral: Somatropin
somatropin, associated names: Genotropin, Humatrope, Maxomat, Norditropin, Saizen, Zomacton, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 15/12/2011, EC decision date: 27/02/2012, -
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Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 20/01/2012, -
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Referral: Terpenic derivatives
camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needle, eucalyptus and turpentine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/11/2011, EC decision date: 20/01/2012, -
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Referral: Pholcodine
Pholcodine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/12/2011, EC decision date: 17/02/2012, -
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Referral: Dexrazoxane
dexrazoxane, associated names: Cardioxane, Cyrdanax, Dexrazoxane Cyathus, Enaxozar, Procard, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 13/09/2011, Last updated: 16/01/2012 -
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Referral: Bufexamac
bufexamac, associated names: Parfenac, Bufal, Calmaderm, Fansamac, Mastu S, Parfenoide, Proctosan, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 22/04/2010, EC decision date: 27/07/2010, -
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Referral: Ketoprofen topical
ketoprofen, associated names: Fastum, Ketum, Orudis, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 22/07/2010, EC decision date: 29/11/2010,