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541 results
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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: 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: Zinbryta
daclizumab, associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, opinion/position date: 09/11/2017, EC decision date: 08/01/2018, 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: Zanil and associated names, and generic products thereof
oxyclozanide, associated names: Zanil Suspension, Zanil Fluke Drench, Zanil Fluke Drench 34 mg/ml Oral Suspension, Article 35
Status: European Commission final decision, opinion/position date: 13/07/2017, EC decision date: 28/09/2017, Last updated: 25/10/2017 -
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Referral: Moxidectin-containing veterinary medicines used in cattle, sheep and horses
moxidectin, associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 11/05/2017, Last updated: 24/10/2017 -
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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: Zinc oxide
zinc oxide, Article 35
Status: European Commission final decision, opinion/position date: 16/03/2017, EC decision date: 26/06/2017, Last updated: 14/08/2017 -
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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: Methylprednisolone injection for cattle
methylprednisolone hydrogen succinate, Article 35
Status: European Commission final decision, opinion/position date: 16/03/2017, EC decision date: 20/06/2017, Last updated: 04/08/2017 -
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Referral: Tylosin injection for mastitis
tylosin, Article 35
Status: European Commission final decision, opinion/position date: 16/03/2017, EC decision date: 10/07/2017, Last updated: 31/07/2017 -
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Referral: Cardioxane
dexrazoxane, Article 13 referrals
Status: European Commission final decision, opinion/position date: 19/07/2017, EC decision date: 19/07/2017, Last updated: 26/07/2017 -
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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: SGLT2 inhibitors (previously canagliflozin)
canagliflozin, empagliflozin, dapagliflozin, metformin, associated names: Xigduo, Ebymect, Edistride, Synjardy, Forxiga, Jardiance, Vokanamet, Invokana, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 04/05/2017, Last updated: 08/05/2017