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141 results
Medicine
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Article 6(12) referrals (prior to January 2010) Remove Article 6(12) referrals (prior to January 2010) filter
Article 6(13) referrals (prior to January 2010) Remove Article 6(13) referrals (prior to January 2010) filter
Article 31 referrals Remove Article 31 referrals filter
Article 107 procedures (prior to July 2012) Remove Article 107 procedures (prior to July 2012) filter
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Referral: Semler
Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 22/09/2016, Last updated: 17/11/2016 -
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Referral: Alkem
Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2016, EC decision date: 08/09/2016, Last updated: 07/10/2016 -
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Referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease
beclometasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 28/04/2016, EC decision date: 29/06/2016, Last updated: 15/07/2016 -
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Referral: Ambroxol and bromhexine-containing medicines
ambroxol, bromhexine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/11/2015, EC decision date: 14/01/2016, Last updated: 05/02/2016 -
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Referral: Adrenaline auto-injectors
adrenaline (epinephrine), Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/06/2015, EC decision date: 14/08/2015, Last updated: 26/08/2015 -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015 -
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Referral: Polymyxin-containing medicines
colistimethate sodium, associated names: Colobreathe, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 16/12/2014, Last updated: 05/01/2015 -
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Referral: Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum
bromocriptine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/08/2014, EC decision date: 30/10/2014, Last updated: 08/12/2014 -
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Referral: Emergency contraceptives
levonorgestrel, ulipristal acetate, associated names: Norlevo, Levonelle/Postinor and Levodonna, ellaOne, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/07/2014, EC decision date: 30/09/2014, Last updated: 24/10/2014 -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014 -
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Referral: Diacerein-containing medicines for oral administration
diacerein, associated names: Zondar, Article 31 referrals
Status: European Commission final decision, EC decision date: 04/09/2014, Last updated: 19/09/2014 -
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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, Last updated: 11/09/2014 -
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Referral: Domperidone-containing medicines
domperidone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 01/09/2014, Last updated: 11/09/2014 -
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Referral: Caustinerf arsenical and Yranicid arsenical
ephedrine hydrochloride, lidocaine, arsenous anhydride, Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/04/2014, EC decision date: 11/07/2014, Last updated: 06/08/2014 -
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Referral: Zolpidem-containing medicines
zolpidem, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 23/06/2014, Last updated: 04/08/2014 -
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Referral: Ketoconazole-containing medicines
ketoconazole, associated names: Nizoral, Fungoral, Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/07/2013, EC decision date: 11/10/2013, Last updated: 13/06/2014 -
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Referral: Methysergide-containing medicines
methysergide, associated names: Deseril, Desernil, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/02/2014, EC decision date: 28/04/2014, Last updated: 27/05/2014 -
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Referral: Substances related to nicotinic acid
acipimox, associated names: Olbetam, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/12/2013, EC decision date: 20/02/2014, Last updated: 13/03/2014 -
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Referral: Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines
monovalent and multivalent measles, mumps, rubella and varicella vaccines (live), 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: Intravenous nicardipine medicines
nicardipine, associated names: Cardene IV, Loxen, Nicardipine Aguettant, Nicardipine Arrow, Rydene, Vasonase, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/10/2013, EC decision date: 20/12/2013, Last updated: 12/03/2014 -
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Referral: Thiocolchicoside-containing medicines
thiocolchicoside, associated names: Muscoril and Coltramyl, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/11/2013, EC decision date: 17/01/2014, Last updated: 06/03/2014 -
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Referral: Ergot derivatives
dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline, dihydroergocryptine, caffeine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 27/09/2013, Last updated: 17/02/2014 -
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Referral: Metoclopramide-containing medicines
metoclopramide, associated names: Maxolon, Primperan, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/10/2013, EC decision date: 20/12/2013, Last updated: 06/02/2014 -
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Referral: Combined hormonal contraceptives
desogestrel, gestodene, norgestimate, etonogestrel, drospirenone, dienogest, chlormadinone, nomegestrol, norelgestromin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/01/2014, Last updated: 31/01/2014 -
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Referral: Diclofenac-containing medicines
diclofenac, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 25/09/2013, Last updated: 27/11/2013