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250 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 30 referrals Remove Article 30 referrals filter Article 34 Remove Article 34 filter

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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: Fortekor

benazepril hydrochloride, Article 34
Status: European Commission final decision, opinion/position date: 10/11/2011, EC decision date: 06/02/2012, Last updated: 11/03/2019
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Referral: Scandonest and associated names

mepivacaine, associated names: Biocaine, Scandicaine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 31/05/2018, EC decision date: 02/08/2018, Last updated: 07/08/2018
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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: Girolan and its associated name Apralan

apramycin sulfate, associated names: Apralan, Article 34
Status: European Commission final decision, Last updated: 15/06/2018
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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: Flupirtine-containing medicinal products

flupirtine, Article 31 referrals
Status: CMDh final position, opinion/position date: 21/03/2018, Last updated: 04/05/2018
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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: 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: Lincocin and its associated names

lincomycin, Article 34
Status: European Commission final decision, opinion/position date: 13/07/2017, EC decision date: 05/10/2017, Last updated: 14/11/2017
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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: 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: Denagard 45%

tiamulin hydrogen fumarate, associated names: Tiamutin 45%, Denagard 450 mg/g, Denagard vet 450 mg/g, Article 34
Status: European Commission final decision, opinion/position date: 12/04/2017, EC decision date: 14/07/2017, Last updated: 11/08/2017
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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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250 results

Referral: Quinolone- and fluoroquinolone-containing medicinal products

Referral: Fortekor

Referral: Scandonest and associated names

Referral: Seresto and its associated name Foresto

Referral: Retinoid-containing medicinal products

Referral: Girolan and its associated name Apralan

Referral: Valproate and related substances

Referral: Flupirtine-containing medicinal products

Referral: Paracetamol modified-release

Referral: Hydroxyethyl starch solutions for infusion

Referral: Factor VIII

Referral: Gadolinium-containing contrast agents

Referral: Vancomycin-containing medicines

Referral: Lincocin and its associated names

Referral: Symbioflor 2

Referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions

Referral: Denagard 45%

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