50 results
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Opinion on medicine for use outside EU: Lamivudine / Zidovudine ViiV (previously Lamivudine / Zidovudine GSK)
lamivudine, zidovudine, HIV Infections, ATC code: J05AR01 Opinion number: H/W/672, Withdrawn opinion Opinion date: 17/11/2005, Last updated: 05/07/2018 -
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Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 20/01/2012, Last updated: 19/04/2012 -
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Public data from Article 57 database
Last updated: 30/06/2023 -
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List of medicines under additional monitoring (updated)
Last updated: 26/09/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 September 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 25/09/2023 to 28/09/2023, Last updated: 25/09/2023 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023 (updated)
PRAC, Last updated: 29/09/2023 -
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EudraVigilance: electronic reporting
Last updated: 15/02/2022 -
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Organisation Management System (OMS) Trouble Shooting Session for CTIS users - October 2022
Online, 14:00 - 15:00 Amsterdam time (CEST), 19/10/2022, Last updated: 29/11/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 October 2021
European Medicines Agency, Amsterdam, the Netherlands, from 25/10/2021 to 28/10/2021, Last updated: 02/08/2022 -
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Organisation Management System (OMS) Trouble Shooting Session for CTIS users - July 2022
Online, 14:00 - 15:00 Amsterdam time (CEST), 21/07/2022, Last updated: 21/09/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 July 2021
European Medicines Agency, Amsterdam, the Netherlands, from 05/07/2021 to 08/07/2021, Last updated: 10/05/2022 -
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Press release: EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
Last updated: 24/03/2017 -
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Organisation Management System (OMS) Trouble Shooting Session for CTIS users - June 2022
Online, 14:00 - 15:00 Amsterdam time (CEST), 30/06/2022, Last updated: 08/07/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 25/09/2023 -
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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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Organisation Management System (OMS) Trouble Shooting Session for CTIS users - November 2022
Online, 14:00 - 15:00 Amsterdam time (CEST), 24/11/2022, Last updated: 25/01/2023 -
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PRAC recommendations on safety signals (updated)
Last updated: 25/09/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 31 August-3 September 2020
Virtual meeting, from 31/08/2020 to 03/09/2020, Last updated: 27/02/2018 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 July 2021
PRAC, Last updated: 09/07/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
PRAC, Last updated: 29/10/2021 -
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Guidance documents
Last updated: 19/07/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 July 2018
European Medicines Agency, London, UK, from 09/07/2018 to 12/07/2018, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 June 2016
European Medicines Agency, London, UK, from 06/06/2016 to 09/06/2016, Last updated: 13/03/2014 -
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CHMP: meeting archive 2016-2018
Last updated: 26/02/2020 -
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PRAC: meeting archive 2015-2017
Last updated: 13/05/2016