10 results
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Referral: Procaine benzylpenicillin
Article 82
Status: Procedure started, opinion/position date: 18/02/2022, Last updated: 20/07/2023 -
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Referral: Modified live porcine respiratory and reproductive syndrome (PRRS) virus vaccines
Porcine respiratory and reproductive syndrome virus vaccine (live), associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 15/04/2021, EC decision date: 13/07/2021, Last updated: 28/07/2021 -
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Referral: Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products
albendazole, Article 35
Status: European Commission final decision, opinion/position date: 05/11/2020, EC decision date: 18/01/2021, Last updated: 22/02/2021Italy Valbazen 100 mg/ml sospensione per uso orale per bovini … Sverminator 10, 100 mg/ml, sospensione orale per bovini ed ovini … Albex Gold 200 mg/ml sospensione orale per bovini Albendazole … -
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Referral: Florgane
florfenicol, Article 33
Status: European Commission final decision, opinion/position date: 06/03/2013, EC decision date: 23/05/2013, Last updated: 10/07/2013Belgium Florgane 300 mg/ml sospensione iniettabile per bovini e … -
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Referral: Cevazuril
toltrazuril, Article 33
Status: European Commission final decision, opinion/position date: 09/12/2009, EC decision date: 26/03/2010, Last updated: 05/05/2010FRANCE CEVAZURIL 50 mg/ml, sospensione orale per suinetti Oral … -
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Referral: Terfenadine
terfenadine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/11/1997, EC decision date: 22/09/1998, Last updated: 22/01/1998 -
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Orphan designation: Mercaptopurine for: Treatment of acute lymphoblastic leukaemia
Date of designation: 30/04/2009, Expired, Last updated: 05/05/2022 -
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Orphan designation: Beta-artemether, lumefantrine for: Treatment of malaria
Date of designation: 28/01/2010, Positive, Last updated: 25/02/2010 -
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Public data from Article 57 database
Last updated: 09/10/2023 -
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Guidance documents related to data submission for authorised medicines
Last updated: 19/07/2022