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229 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 6(12) referrals (prior to January 2010) Remove Article 6(12) referrals (prior to January 2010) filter Article 30 referrals Remove Article 30 referrals filter Article 31 referrals Remove Article 31 referrals filter Article 29 paediatrics Remove Article 29 paediatrics filter

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List item

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: Vancomycin-containing medicines

vancomycin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/05/2017, EC decision date: 21/09/2017, Last updated: 17/11/2017
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Referral: Symbioflor 2

escherichia coli bacteria (cells and autolysate), associated names: Symbioflor E. Coli, Symbioflor® 2, Symbioflor Escherichia, Article 31 referrals
Status: European Commission final decision, EC decision date: 22/06/2017, Last updated: 07/09/2017
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Referral: Vepesid

etoposide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2017, EC decision date: 26/06/2017, Last updated: 14/07/2017
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Referral: Etopophos

etoposide phosphate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2017, EC decision date: 26/06/2017, Last updated: 14/07/2017
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Referral: Micro Therapeutic Research

Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/03/2017, EC decision date: 23/06/2017, Last updated: 10/07/2017
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Referral: Saroten and associated names

amitriptyline, associated names: Saroten Retard, Redomex, Redomex Diffucaps, Saroten Tabs, Saroten retard Tabs, Saroten 2ml, Sarotex, Sarotex Retard, Sarotex Retard 25, Sarotex Retard 50, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 08/05/2017, Last updated: 06/06/2017
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Referral: Haldol Decanoate and associated names

haloperidol decanoate, associated names: Haldol Decanoat, Haldol Decanoas, Serenase Dekanoat, Serenase Depot, Haldol - Janssen Decanoat Depot, Haldol Decanoato, Haldol Depot, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 28/04/2017, Last updated: 11/05/2017
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Referral: Haldol and associated names

haloperidol, associated names: Aloperidin, Haldol-Janssen, Serenase, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 28/04/2017, Last updated: 05/05/2017
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Referral: Dienogest/ethinylestradiol-containing medicinal products indicated in acne

dienogest, ethinyl estradiol, 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: Lovenox and associated names

enoxaparin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 09/03/2017, 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.

sodium phenylbutyrate, progesterone, dutasteride, colecalciferol, 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: Clenil and associated names

beclometasone dipropionate, associated names: Becloneb, Beclospin and Sanasthmax, Article 30 referrals
Status: European Commission final decision, opinion/position date: 15/09/2016, EC decision date: 11/11/2016, Last updated: 18/11/2016
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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: Durogesic and associated names

fentanyl, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 22/09/2016, Last updated: 19/10/2016
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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: Novantrone and associated names

mitoxantrone, associated names: Elsep, Ralenova, Article 30 referrals
Status: European Commission final decision, opinion/position date: 28/04/2016, EC decision date: 24/06/2016, Last updated: 05/07/2016
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Referral: Cymevene

ganciclovir, associated names: Cymevan, Citovirax, Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 28/04/2016, Last updated: 21/06/2016
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Referral: Amoxil

amoxicillin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/06/2015, EC decision date: 20/08/2015, Last updated: 19/05/2016
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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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229 results

Referral: Factor VIII

Referral: Gadolinium-containing contrast agents

Referral: Vancomycin-containing medicines

Referral: Symbioflor 2

Referral: Vepesid

Referral: Etopophos

Referral: Micro Therapeutic Research

Referral: Saroten and associated names

Referral: Haldol Decanoate and associated names

Referral: Haldol and associated names

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

Referral: Lovenox and associated names

Referral: Metformin and metformin-containing medicines

Referral: Pharmaceutics International Inc.

Referral: Clenil and associated names

Referral: Semler

Referral: Durogesic and associated names

Referral: Alkem

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

Referral: Novantrone and associated names

Referral: Cymevene

Referral: Amoxil

Referral: Ambroxol and bromhexine-containing medicines

Referral: Adrenaline auto-injectors

Referral: GVK Biosciences