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122 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter

Referral type Article 31 referrals Remove Article 31 referrals filter Article 36 referrals (prior to July 2012) Remove Article 36 referrals (prior to July 2012) filter

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Referral status European Commission final decision Remove European Commission final decision filter CMDh final position Remove CMDh final position filter

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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, Last updated: 24/03/2017
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Referral: Intravenous iron-containing medicinal products

ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside, iron sucrose, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 13/09/2013, Last updated: 22/03/2017
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Referral: Metformin and metformin-containing medicines

metformin, associated names: Xigduo, Vipdomet, Velmetia, Synjardy, Ristfor, Komboglyze, Jentadueto, Janumet, Icandra (previously Vildagliptin / metformin hydrochloride Novartis), Glubrava, Eucreas, Efficib, Ebymect, Competact, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/10/2016, EC decision date: 12/12/2016, Last updated: 21/12/2016
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Referral: Pharmaceutics International Inc.

associated names: Ammonaps, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/09/2016, EC decision date: 05/12/2016, Last updated: 14/12/2016
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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

beclomethasone, 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 and 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

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: Ibuprofen- and dexibuprofen-containing medicines

ibuprofen and 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

codeine, 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: 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 and 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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122 results

Referral: Dienogest/ethinylestradiol-containing medicinal products indicated in acne

Referral: Intravenous iron-containing medicinal products

Referral: Metformin and metformin-containing medicines

Referral: Pharmaceutics International Inc.

Referral: Semler

Referral: Alkem

Referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease

Referral: Fusafungine containing medicinal products for oromucosal and nasal use

Referral: Ambroxol and bromhexine-containing medicines

Referral: Adrenaline auto-injectors

Referral: GVK Biosciences

Referral: Ibuprofen- and dexibuprofen-containing medicines

Referral: Hydroxyzine

Referral: Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients

Referral: Valproate and related substances

Referral: Testosterone-containing medicines

Referral: Polymyxin-containing medicines

Referral: Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum

Referral: Emergency contraceptives

Referral: Renin-angiotensin-system (RAS)-acting agents

Referral: Diacerein-containing medicines for oral administration

Referral: Linoladiol N and Linoladiol HN

Referral: Domperidone-containing medicines

Referral: Caustinerf arsenical and Yranicid arsenical

Referral: Zolpidem-containing medicines