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181 results
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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: 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: 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: 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: 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: 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: Veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs
gentamicin, Article 35
Status: European Commission final decision, opinion/position date: 10/11/2016, EC decision date: 27/02/2017, Last updated: 21/04/2017 -
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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: 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: Veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and, or poultry
lincomycin, spectinomycin, associated names: Please see Annex I, Article 35
Status: European Commission final decision, opinion/position date: 19/05/2016, EC decision date: 22/08/2016, Last updated: 16/09/2016 -
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Referral: Altrenogest
altrenogest, Article 35
Status: European Commission final decision, opinion/position date: 19/05/2016, EC decision date: 29/07/2016, Last updated: 08/09/2016 -
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Referral: Colistin combinations
Colistin sulfate, oxytetracycline hydrochloride, trimethoprim, enrofloxacin, Amoxicillin trihydrate, spiramycin adipate, ampicillin trihydrate, erythromycin estolate, scopolamine, sulfaguanidine, neomycin sulfate, sulfadimethoxine, sulfamethoxypyridazine, doxycycline hyclate, sulfadimidine sodium, chlortetracycline hydrochloride, associated names: Please see Annex I, Article 35
Status: European Commission final decision, opinion/position date: 21/04/2016, EC decision date: 14/07/2016, Last updated: 05/08/2016 -
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Referral: Benzathine benzylpenicillin intended for administration to food-producing species
benzathine benzylpenicillin, associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 15/01/2003, EC decision date: 22/04/2003, Last updated: 26/07/2016