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281 results

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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Referral type Article 5(11) referrals (prior to January 2010) Remove Article 5(11) referrals (prior to January 2010) filter Article 13 Remove Article 13 filter Article 107i procedures Remove Article 107i procedures filter Article 31 referrals Remove Article 31 referrals filter Article 33 Remove Article 33 filter Article 29(4) referrals Remove Article 29(4) referrals filter

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Referral: Syner-Kinase and associated names

urokinase, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 28/02/2019, EC decision date: 16/05/2019, Last updated: 03/06/2019
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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: Diotop capsules

diclofenac, omeprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 31/01/2019, Last updated: 15/02/2019
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Referral: Diclofenac Sodium Spray Gel 4%

diclofenac sodium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 18/01/2019, Last updated: 14/02/2019
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Referral: Perlinring and associated names

etonogestrel, ethinylestradiol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/10/2018, EC decision date: 18/12/2018, Last updated: 21/01/2019
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Referral: Paclitaxel Hetero and associated names

paclitaxel, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/10/2018, EC decision date: 11/01/2019, Last updated: 21/01/2019
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Referral: Seresto and its associated name Foresto

imidacloprid, flumethrin, associated names: Foresto, Article 13
Status: European Commission final decision, opinion/position date: 15/02/2018, EC decision date: 25/05/2018, Last updated: 10/07/2018
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Referral: Retinoid-containing medicinal products

acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene, associated names: Targretin, Panretin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/03/2018, EC decision date: 21/06/2018, Last updated: 02/07/2018
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Referral: Valproate and related substances

sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide, associated names: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/03/2018, EC decision date: 31/05/2018, Last updated: 07/06/2018
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Referral: Paracetamol modified-release

paracetamol, associated names: Alvedon, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2017, EC decision date: 19/02/2018, Last updated: 01/03/2018
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Referral: Hydroxyethyl starch solutions for infusion

hydroxyethyl starch, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 12/01/2018
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Referral: Alcover and associated names

sodium oxybate, associated names: n/a, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 26/01/2017, EC decision date: 18/12/2017, Last updated: 12/01/2018
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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: 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: Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets

paracetamol, ibuprofen, associated names: Paracomb, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/05/2017, EC decision date: 07/08/2017, Last updated: 18/08/2017
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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: 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: 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: 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: Diclofenac epolamine 50 mg tablets

diclofenac, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 22/09/2016, Last updated: 10/10/2016
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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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281 results

Referral: Syner-Kinase and associated names

Referral: Metamizole containing medicinal products

Referral: Quinolone- and fluoroquinolone-containing medicinal products

Referral: Diotop capsules

Referral: Diclofenac Sodium Spray Gel 4%

Referral: Perlinring and associated names

Referral: Paclitaxel Hetero and associated names

Referral: Seresto and its associated name Foresto

Referral: Retinoid-containing medicinal products

Referral: Valproate and related substances

Referral: Paracetamol modified-release

Referral: Hydroxyethyl starch solutions for infusion

Referral: Alcover and associated names

Referral: Factor VIII

Referral: Gadolinium-containing contrast agents

Referral: Vancomycin-containing medicines

Referral: Symbioflor 2

Referral: Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets

Referral: Micro Therapeutic Research

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

Referral: Metformin and metformin-containing medicines

Referral: Pharmaceutics International Inc.

Referral: Semler

Referral: Diclofenac epolamine 50 mg tablets

Referral: Alkem