56 results
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Human medicine European public assessment report (EPAR): VidPrevtyn Beta
SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain), COVID-19 virus infection
Date of authorisation: 10/11/2022,
, Authorised, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Skysona
elivaldogene autotemcel, Adrenoleukodystrophy
Date of authorisation: 16/07/2021,, Withdrawn, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Ioa
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 16/11/2011, Revision: 4, Withdrawn, Last updated: 26/08/2014 -
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Withdrawn application: Ogivri
date of withdrawal: 03/08/2017, Initial authorisation, Last updated: 28/11/2017 -
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Withdrawn application: Qizenday
date of withdrawal: 13/11/2017, Initial authorisation, Last updated: 06/02/2018 -
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Withdrawn application: Plivensia
date of withdrawal: 26/10/2017, Initial authorisation, Last updated: 10/11/2017 -
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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: Combined hormonal contraceptives
desogestrel, gestodene, norgestimate, etonogestrel, drospirenone, dienogest, chlormadinone, nomegestrol, norelgestromin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/01/2014, Last updated: 31/01/2014 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants
Online, 13:00 - 17:00 Amsterdam time (CET), 15/12/2022, Last updated: 10/02/2023 -
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Download medicine data
Last updated: 02/12/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018
European Medicines Agency, London, UK, from 05/03/2018 to 08/03/2018, Last updated: 05/03/2018CLOPIDOGREL BGR (CAP), CLOPIDOGREL HCS (CAP), CLOPIDOGREL KRKA … -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 July 2010
European Medicines Agency, London, UK, from 19/07/2010 to 22/07/2010, Last updated: 16/02/2010Plavix. • Clopidogrel HCS and Clopidogrel Teva Generics … Teva Pharma B.V. and from HCS bvba, for the prevention … atherothrombotic events. Clopidogrel HCS and Clopidogrel Teva Generics … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,22-25 June 2009
CHMP, Last updated: 26/06/2009Mylan dura GmbH, Clopidogrel HCS (clopidogrel … http://www.emea.europa.eu/humandocs/PDFs/EPAR/chondrocelect/39474109en.pdf as hydrochloride), from HCS bvba, Clopidogrel Mylan (clopidogrel … -
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Committee for Medicinal Products for Human Use (CHMP): 15-18 November 2010
European Medicines Agency, London, UK, from 15/11/2010 to 18/11/2010, Last updated: 16/02/2010 -
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Outcomes of imposed non-interventional post-authorisation safety studies
Last updated: 27/06/2022 -
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Annual reports and work programmes (updated)
Last updated: 15/05/2023 -
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CHMP: meeting archive 2010-2012
Last updated: 17/12/2013 -
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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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Paediatric Committee (PDCO): 9-11 January 2013
European Medicines Agency, London, UK, from 09/01/2013 to 11/01/2013, Last updated: 21/12/2010 -
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News: Annual report 2009 published: "Agency achieved very good results in one of the most challenging years in its history"
Last updated: 20/05/2010 -
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Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products
European Medicines Agency, London, UK, from 15/11/2016 to 16/11/2016, Last updated: 08/11/2016 -
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Clinical investigation of medicinal products for the treatment of chronic constipation - Scientific guideline
Last updated: 14/09/2015 -
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News: EMA publishes 2013 annual report
Last updated: 30/04/2014