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87 results
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Referral: Factor VIII
associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, Last updated: 05/12/2017 -
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Referral: Gadolinium-containing contrast agents
gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide, gadoxetic acid, associated names: Optimark, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/07/2017, EC decision date: 23/11/2017, Last updated: 04/12/2017 -
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Referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions
methylprednisolone, Article 31 referrals
Status: CMDh final position, opinion/position date: 31/07/2017, Last updated: 04/09/2017 -
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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: Fusafungine containing medicinal products for oromucosal and nasal use
fusafungine, Article 31 referrals
Status: CMDh final position, opinion/position date: 31/03/2016, Last updated: 14/04/2016 -
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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: Ibuprofen- and dexibuprofen-containing medicines
ibuprofen, dexibuprofen, Article 31 referrals
Status: CMDh final position, opinion/position date: 20/05/2015, Last updated: 14/07/2015 -
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Referral: Hydroxyzine
hydroxyzine, associated names: Atarax, Article 31 referrals
Status: CMDh final position, opinion/position date: 25/03/2015, Last updated: 08/06/2015 -
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Referral: Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients
Article 31 referrals
Status: CMDh final position, opinion/position date: 22/04/2015, Last updated: 18/05/2015 -
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Referral: Valproate and related substances
sodium valproate, valproic acid, valproate semisodium, valpromide, associated names: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel, Article 31 referrals
Status: CMDh final position, opinion/position date: 19/11/2014, Last updated: 29/01/2015 -
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Referral: Testosterone-containing medicines
testosterone, Article 31 referrals
Status: CMDh final position, opinion/position date: 19/11/2014, Last updated: 08/01/2015 -
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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: 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: 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: Methadone medicinal products for oral use containing povidone
methadone, Article 107i procedures
Status: CMDh final position, opinion/position date: 23/07/2014, Last updated: 04/08/2014 -
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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: 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: Hydroxyethyl starch solutions for infusion
hydroxyethyl starch, Article 107i procedures
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 06/03/2014 -
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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 -
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Referral: Flupirtine-containing medicines
flupirtine, Article 107i procedures
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 05/09/2013, Last updated: 21/11/2013 -
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Referral: Short-acting beta-agonists
terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol, isoxsuprine, Article 31 referrals
Status: CMDh final position, opinion/position date: 23/10/2013, Last updated: 07/11/2013 -
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Referral: Numeta G13%E and Numeta G16%E emulsion for infusion
Article 107i procedures
Status: CMDh final position, opinion/position date: 18/09/2013, Last updated: 27/09/2013 -
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Referral: Cyproterone- and ethinylestradiol-containing medicines
cyproterone, ethinyl estradiol, associated names: Acnemine, Acneson, Chloe, Clairette, Cyprest, Cyprodiol, Diane 35, Dianette, Feminil, Minerva, Zyrona, Article 107i procedures
Status: European Commission final decision, opinion/position date: 29/05/2013, EC decision date: 25/07/2013, Last updated: 05/08/2013