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Press release: European Medicines Agency starts review of ibuprofen medicines
PRAC, Last updated: 13/06/2014European Medicines Agency starts review of ibuprofen … The European Medicines Agency's (EMA's) Pharmacovigilance … 4HB ● United Kingdom An agency of the European Union … -
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Press release: PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system
PRAC, Last updated: 11/04/2014PRAC recommends against combined use of medicines … The European Medicines Agency's Pharmacovigilance Risk Assessment … medicines (called RAS-acting agents) belong to three main classes … -
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News: European Medicines Agency launches public consultation on rules of procedures for public hearings
PRAC, Last updated: 24/07/2014European Medicines Agency launches public consultation … 24/07/2014 The European Medicines Agency (EMA) has today launched … 4HB ● United Kingdom An agency of the European Union … -
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News: European Medicines Agency begins to publish recommendations based on safety signals
PRAC, Last updated: 04/10/2013European Medicines Agency begins to publish recommendations … 04/10/2013 The European Medicines Agency has published the first overview … the recommendations. The Agency will publish future overviews … -
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News: European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics
PRAC, Last updated: 17/05/2013European Medicines Agency reiterates PRAC recommendation … group, the French National Agency for the Safety of Medicine … approach. The European Medicines Agency reiterates the PRAC recommendation … -
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Press release: European Medicines Agency starts safety review of Diane 35 and its generics
PRAC, Last updated: 08/02/2013European Medicines Agency starts safety review of Diane … The European Medicines Agency's Pharmacovigilance Risk Assessment … French medicines regulatory agency (ANSM), following the announcement … -
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News: European Medicines Agency increases transparency of ongoing applications for human medicines
PRAC, Last updated: 07/11/2012European Medicines Agency increases transparency of … 07/11/2012 The European Medicines Agency has started publishing information … Website www.ema.europa.eu An agency of the European Union © … -
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Press release: European Medicines Agency holds first meeting of the Pharmacovigilance Risk Assessment Committee (PRAC)
PRAC, Last updated: 19/07/2012European Medicines Agency holds first meeting of the … The European Medicines Agency is holding the first meeting … holding public hearings, and agendas and minutes of its meetings … -
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Press release: PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations
PRAC, Last updated: 10/03/2017assessment of gadolinium agents used in body scans and recommends … linear gadolinium contrast agents because of evidence that … deposited in the brain. The agents concerned are intravenous … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/02/2021 to 11/02/2021, Last updated: 08/02/202111/02/2021 European Medicines Agency, Amsterdam, the Netherlands … for human use. Documents Agenda - PRAC draft agenda of meeting 8-11 February … PDF icon application/pdf agenda_-_prac_draft_agenda_of_meeting_08-11_february_2021_en.pdf Draft 08/02/2021 EMA/PRAC/80497/2021 … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 23-26 November 2020
Virtual meeting, from 23/11/2020 to 26/11/2020, Last updated: 27/11/2020EMA/PRAC/87359/2021 Generic Agenda - PRAC draft agenda of meeting 23-26 November … icon application/pdf prac_agenda_23-26_nov_2020_en.pdf Draft … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2020
European Medicines Agency, Amsterdam, the Netherlands, from 06/07/2020 to 09/07/2020, Last updated: 10/12/202009/07/2020 European Medicines Agency, Amsterdam, the Netherlands … for human use. Documents Agenda - PRAC draft agenda of meeting 6-9 July 2020 … icon application/pdf prac_agenda_06-09_july_2020_-_for_publication_en.pdf … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 September 2016
European Medicines Agency, London, UK, from 26/09/2016 to 29/09/2016, Last updated: 13/03/201429/09/2016 European Medicines Agency, London, UK The Pharmacovigilance … EMA/PRAC/123588/2017 Generic Agenda - PRAC draft agenda of meeting 26-29 September … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 March 2013
European Medicines Agency, London, UK, from 04/03/2013 to 07/03/2013, Last updated: 02/06/201207/03/2013 European Medicines Agency, London, UK The Pharmacovigilance … 26/04/2013 EMA/248666/2013 Generic Agenda - PRAC draft agenda of meeting 4 -7 March 2013 … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 February 2018
European Medicines Agency, London, UK, from 05/02/2018 to 08/02/2018, Last updated: 13/03/201408/02/2018 European Medicines Agency, London, UK The Pharmacovigilance … EMA/PRAC/218598/2018 Generic Agenda - PRAC draft agenda of meeting 5-8 February 2018 … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 25-29 September 2017
European Medicines Agency, London, UK, from 25/09/2017 to 29/09/2017, Last updated: 06/09/201729/09/2017 European Medicines Agency, London, UK The Pharmacovigilance … EMA/PRAC/782068/2017 Generic Agenda - PRAC draft agenda of meeting 25-29 September … EMA/PRAC/634126/2017 Generic Agenda - Public hearing: Valproate … -
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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: 13/03/201411/02/2016 European Medicines Agency, London, UK The Pharmacovigilance … for human use. Documents Agenda - PRAC draft agenda of meeting 8-11 February … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 September 2015
European Medicines Agency, London, UK, from 07/09/2015 to 10/09/2015, Last updated: 13/03/201410/09/2015 European Medicines Agency, London, UK The Pharmacovigilance … EMA/PRAC/722174/2015 Generic Agenda - PRAC draft agenda of meeting 7-10 September … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 September 2013
European Medicines Agency, London, UK, from 02/09/2013 to 05/09/2013, Last updated: 02/07/201205/09/2013 European Medicines Agency, London, UK The Pharmacovigilance … EMA/PRAC/550442/2013 Generic Agenda - PRAC draft agenda of meeting 2-5 September … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2014
European Medicines Agency, London, UK, from 07/04/2014 to 10/04/2014, Last updated: 13/08/201310/04/2014 European Medicines Agency, London, UK The Pharmacovigilance … EMA/PRAC/210690/2014 Generic Agenda - PRAC draft agenda of meeting 7-10 April 2014 … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 February 2015
European Medicines Agency, London, UK, from 09/02/2015 to 12/02/2015, Last updated: 13/03/201412/02/2015 European Medicines Agency, London, UK The Pharmacovigilance … EMA/PRAC/147021/2015 Generic Agenda - PRAC draft agenda of meeting 9-12 February … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 March 2015
European Medicines Agency, London, UK, from 09/03/2015 to 12/03/2015, Last updated: 13/03/201412/03/2015 European Medicines Agency, London, UK The Pharmacovigilance … EMA/PRAC/257790/2015 Generic Agenda - PRAC draft agenda of meeting 9-12 March 2015 … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 July 2014
European Medicines Agency, London, UK, from 07/07/2014 to 10/07/2014, Last updated: 13/08/201310/07/2014 European Medicines Agency, London, UK The Pharmacovigilance … EMA/PRAC/501208/2014 Generic Agenda - PRAC draft agenda of meeting 7-10 July 2014 … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 June 2013
European Medicines Agency, London, UK, from 10/06/2013 to 13/06/2013, Last updated: 02/07/201213/06/2013 European Medicines Agency, London, UK The Pharmacovigilance … EMA/PRAC/430682/2013 Generic Agenda - PRAC draft agenda of meeting 10-13 June 2013 … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 February 2017
European Medicines Agency, London, UK, from 06/02/2017 to 09/02/2017, Last updated: 13/03/201409/02/2017 European Medicines Agency, London, UK The Pharmacovigilance … for human use. Documents Agenda - PRAC draft agenda of meeting 6-9 February 2017 … Assessment Committee (PRAC) PRAC: Agendas, minutes and highlights Topics: …