42 results
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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Date of designation: 15/05/2009, Withdrawn, Last updated: 21/10/2016 -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Date of designation: 05/03/2002, Withdrawn, Last updated: 17/10/2013γλοιώματος Italian Carmustina (soluzione iniettabile per via intratumorale … -
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Outcomes of imposed non-interventional post-authorisation safety studies
Last updated: 27/06/2022 -
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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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Public data from Article 57 database
Last updated: 30/06/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 March 2017
European Medicines Agency, London, UK, from 20/03/2017 to 23/03/2017, Last updated: 20/03/2017 -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 12/09/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 18-21 April 2017
European Medicines Agency, London, UK, from 18/04/2017 to 21/04/2017, Last updated: 06/01/2014 -
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Guidance documents
Last updated: 19/07/2022 -
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CHMP: meeting archive 2016-2018
Last updated: 26/02/2020