42 results
Keyword Esomeprazolo KRKA Remove keyword
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Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient
associated names: Vectra 3D, Melovem, Article 82
Status: European Commission final decision, opinion/position date: 08/12/2022, EC decision date: 28/03/2023, Last updated: 14/04/2023 -
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Referral: Baytril injectable and generics
enrofloxacin, Article 35
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 01/09/2014, Last updated: 10/12/2014Cattle, pigs Austria Krka d.d. Novo mesto Smarjeska … Calves, pigs, dogs Austria Krka d.d. Novo mesto Smarjeska … -
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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: 16/07/2010intramuscular Austria Krka, d. d., Novo mesto Šmarješka … Turkeys Oral Austria Krka, d. d., Novo mesto Šmarješka … administration Austria Krka, d. d., Novo mesto Šmarješka … -
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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: Veterinary medicines containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys
enrofloxacin, Article 35
Status: European Commission final decision, opinion/position date: 07/11/2013, EC decision date: 28/02/2014, Last updated: 10/04/2014 -
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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: 21/04/2017dogs, cats IM, SC Croatia Krka - Farma d.o.o. Radnička … -
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Referral: Injectable veterinary medicinal products containing vitamin A for use in food producing species
Vitamin A (retinol and its esters), Article 35
Status: European Commission final decision, opinion/position date: 12/05/2021, EC decision date: 18/08/2021, Last updated: 27/09/2021subcutaneous use Croatia Krka - Farma d.o.o. Radnička … -
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Referral: Flukicides for which no maximum residue limit has been established in milk and which are intended for use in ruminants producing milk for human consumption
clorsulon, closantel, nitroxinil, rafoxanide, triclabendazole, Article 35
Status: European Commission final decision, opinion/position date: 14/06/2012, EC decision date: 19/11/2012, Last updated: 18/01/2013 -
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Referral: Gentamicin
gentamicin, Article 35
Status: European Commission final decision, opinion/position date: 06/11/2014, EC decision date: 11/02/2015, Last updated: 10/04/2015producing horses) Croatia Krka - Farma d.o.o. Radnička … -
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CVMP: Agendas, minutes and reports (updated)
Last updated: 15/09/2023 -
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Download medicine data
Last updated: 02/12/2021Accord EMEA/H/C/005408 human en https://www.ema.europa.eu/en/documents/product-information/abiraterone-accord-epar-product-information_en.pdf Abiraterone Krka EMEA/H/C/005649 human en https://www.ema.europa.eu/en/documents/product-information/abiraterone-krka-epar-product-information_en.pdf Abiraterone …
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Parallel distribution: Regulatory and procedural guidance
Last updated: 09/06/2021 -
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Integration of EudraGMDP and OMS - Webinar for industry
Online, 14:00-16:30 (CEST), 12/10/2021, Last updated: 10/11/2021 -
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Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 December 2020
Virtual meeting, from 08/12/2020 to 10/12/2020, Last updated: 11/12/2020 -
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Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 April 2021
European Medicines Agency, Amsterdam, the Netherlands, from 13/04/2021 to 15/04/2021, Last updated: 24/06/2021 -
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Sampling and testing
Last updated: 28/03/2019 -
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News: Annual report 2020 published
Last updated: 14/06/2021 -
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Veterinary focus group meeting - Committee for Medicinal Products for Veterinary Use bioequivalence guideline (revision)
London, 06/05/2009, Last updated: 01/05/2009IFAH-Europe) , France Brvar Nina KRKA, Slovenia De Ridder Erik … -
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News: EMA annual report 2022 published
Last updated: 15/05/2023 -
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Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 16/03/2021 to 18/03/2021, Last updated: 28/08/2018 -
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Conduct of bioequivalence studies for veterinary medicinal products - Scientific guideline
Last updated: 26/07/2021 -
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Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 10/05/2021 to 12/05/2021, Last updated: 10/05/2021 -
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News: EMA publishes annual report 2021
Last updated: 10/06/2022