24 results
Keyword Urapidil Stragen Remove keyword
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Orphan designation: Homoharringtonine for: Treatment of acute myeloid leukaemia
Date of designation: 20/10/2004, Withdrawn, Last updated: 10/08/2016the European Commission to Stragen France SAS, for homoharringtonine … the European Commission to Stragen France SAS, for homoharringtonine … -
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Orphan designation: Homoharringtonine for: Treatment of chronic myeloid leukaemia
Date of designation: 02/09/2004, Withdrawn, Last updated: 10/08/2016the European Commission to Stragen France SAS, France, for homoharringtonine … the European Commission to Stragen France SAS, France, for homoharringtonine … -
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National expert: Aleksandar Knezevic, Agency for Medicinal Products and Medical Devices of Croatia (updated)
- Declaration of interests - 84.22 KB | PDF
- Curriculum Vitae - 31.91 KB | PDF
Tucan-Foretic M. Utjecaj urapidila na inducirani bronhospazam … -
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Withdrawn application: Tekinex
date of withdrawal: 11/01/2011, Initial authorisation, Last updated: 31/01/2011 -
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Referral: Nomegestrol and chlormadinone
nomegestrol, chlormadinone, associated names: Zoely, Article 31 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 01/09/2022, Last updated: 02/09/2022 -
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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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Referral: Cyproterone- and ethinylestradiol-containing medicines
cyproterone, ethinyl estradiol, associated names: Acnemine, Acneson, Chloe, Clairette, Cyprest, Cyprodiol, Diane 35, Dianette, Feminil, Minerva, Zyrona, Article 107i procedures
Status: European Commission final decision, opinion/position date: 29/05/2013, EC decision date: 25/07/2013, Last updated: 05/08/2013 -
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Public data from Article 57 database (updated)
Last updated: 27/09/2022 -
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Outcomes of imposed non-interventional post-authorisation safety studies
Last updated: 27/06/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2016
European Medicines Agency, London, UK, from 08/02/2016 to 11/02/2016, Last updated: 13/03/2014 -
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Guidance documents
Last updated: 19/07/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 February 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/02/2022 to 10/02/2022, Last updated: 21/06/2021 -
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Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template"
Last updated: 17/06/2014 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7 - 10 February 2022
PRAC, Last updated: 11/02/2022 -
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Periodic safety update reports (PSURs)
Last updated: 27/07/2022 -
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PRAC: Agendas, minutes and highlights
Last updated: 02/09/2022 -
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Article 5(3) opinions
Last updated: 10/01/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 30 November-3 December 2015
European Medicines Agency, London, UK, from 30/11/2015 to 03/12/2015, Last updated: 13/03/2014 -
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News: Feedback requested on the draft list of EU reference dates for periodic safety update reports in preparation for introduction of the new pharmacovigilance legislation
Last updated: 04/04/2012 -
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Annual reports and work programmes
Last updated: 10/06/2022 -
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Periodic safety update reports
Last updated: 26/09/2018 -
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PRAC: meeting archive 2015-2017
Last updated: 13/05/2016 -
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News: European Medicines Agency to begin PSUR assessment based on active substances in both centrally and nationally authorised medicines
Last updated: 27/03/2013 -
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News: European Medicines Agency publishes list of EU reference dates and frequency of PSUR submission
Last updated: 01/10/2012