78 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: 15/06/2018Apralan Solubile polvere per soluzione orale per Suini, Polli da … -
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Referral: Bleomycin
bleomycin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2008, EC decision date: 12/03/2009, Last updated: 31/03/2009 -
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Referral: Nuflor Swine Once
florfenicol, associated names: PigFlor Once, Article 33
Status: European Commission final decision, opinion/position date: 07/02/2013, EC decision date: 16/05/2013, Last updated: 14/06/2013Netherlands NUFLOR Suini One, 450 mg/ml soluzione iniettabile per suini florfenicol … -
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Referral: Toltrazuril
toltrazuril, Article 35
Status: European Commission final decision, opinion/position date: 16/07/2008, EC decision date: 26/09/2008, Last updated: 26/07/2008coccidiosis Italy Baycox soluzione 2.5% Bayer S.p.A. Viale … -
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Referral: Doramectin
doramectin, Article 35
Status: European Commission final decision, opinion/position date: 12/06/2013, EC decision date: 06/09/2013, Last updated: 18/10/2013 -
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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: Catophos 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names
Butafosfan, Cyanocobalamin, Article 33 opinion/position date: 15/02/2023, EC decision date: 03/04/2023, Last updated: 25/04/2023 -
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Referral: Vey Tosal 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names
Butafosfan, Cyanocobalamin, Article 33 opinion/position date: 15/02/2023, EC decision date: 03/04/2023, Last updated: 25/04/2023 -
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Referral: Colistin oral
colistin, Article 35
Status: European Commission final decision, opinion/position date: 11/12/2014, EC decision date: 16/03/2015, Last updated: 13/04/2015 -
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Referral: Quinolones
enrofloxacin, marbofloxacin, danofloxacin mesilate, danofloxacin, flumequine, amoxicillin, difloxacin hydrochloride, oxolinic acid, Colistin sulfate, Amoxicillin trihydrate, difloxacin, bromhexine, oxytetracycline hydrochloride, Article 35
Status: European Commission final decision, opinion/position date: 09/03/2010, EC decision date: 01/07/2010, Last updated: 16/07/2010 -
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Orphan designation: ciclosporin for: Treatment of atopic keratoconjunctivitis
Date of designation: 24/07/2009, Positive, Last updated: 11/09/2009 -
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Orphan designation: Octreotide chloride for: Treatment of acromegaly
Date of designation: 12/06/2009, Positive, Last updated: 30/05/2018 -
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Orphan designation: Dexamethasone phosphate for: Treatment of corneal graft rejection
Date of designation: 15/05/2009, Withdrawn, Last updated: 21/10/2016 -
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Orphan designation: carmustine for: Treatment of glioma
Date of designation: 05/03/2002, Withdrawn, Last updated: 17/10/2013γλοιώματος Italian Carmustina (soluzione iniettabile per via intratumorale … -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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News: Hydroxyethyl-starch solutions for infusion recommended for suspension from the market
CMDh, Last updated: 26/07/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/05/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/01/2022 to 13/01/2022, Last updated: 07/10/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 June 2013
European Medicines Agency, London, UK, from 10/06/2013 to 13/06/2013, Last updated: 02/07/2012nutrition, combination - NUMETA G13%E and NUMETA G16%E EMULSION FOR INFUSION … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 September 2013
European Medicines Agency, London, UK, from 02/09/2013 to 05/09/2013, Last updated: 02/07/2012 -
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Pharmacovigilance in the paediatric population workshop
European Medicines Agency, London, UK, 28/04/2014, Last updated: 16/05/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August - 1 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 29/08/2022 to 01/09/2022, Last updated: 02/09/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018
European Medicines Agency, London, UK, from 11/06/2018 to 14/06/2018, Last updated: 10/08/2018 -
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Paediatric Committee (PDCO): 7-9 August 2013
European Medicines Agency, London, UK, from 07/08/2013 to 09/08/2013, Last updated: 21/12/2010 -
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EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP): meeting with all eligible organisations
European Medicines Agency, London, UK, 11/12/2013, Last updated: 07/02/2014