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News: COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
CHMP, PRAC, Last updated: 28/01/2022 -
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Press release: Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing
PRAC, Last updated: 09/02/2018 -
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News: European Medicines Agency launches public consultation on rules of procedures for public hearings
PRAC, Last updated: 24/07/2014 -
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Press release: European Medicines Agency starts review of ibuprofen medicines
PRAC, Last updated: 13/06/2014 -
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News: European Medicines Agency begins to publish recommendations based on safety signals
PRAC, Last updated: 04/10/2013 -
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News: European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics
PRAC, Last updated: 17/05/2013 -
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Press release: European Medicines Agency starts safety review of Diane 35 and its generics
PRAC, Last updated: 08/02/2013 -
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News: European Medicines Agency increases transparency of ongoing applications for human medicines
PRAC, Last updated: 07/11/2012 -
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Press release: European Medicines Agency holds first meeting of the Pharmacovigilance Risk Assessment Committee (PRAC)
PRAC, Last updated: 19/07/2012 -
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News: European Medicines Agency publishes first review of orphan designation
COMP, Last updated: 17/09/2010 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2019
PRAC, Last updated: 17/05/2019 -
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Press release: Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs
PRAC, Last updated: 17/05/2019 -
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Press release: Withdrawal of marketing authorisations for fenspiride medicines
PRAC, Last updated: 17/05/2019 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2019
PRAC, Last updated: 14/06/2019 -
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Press release: EMA review of Picato concludes medicine’s risks outweigh its benefits
PRAC, Last updated: 17/04/2020 -
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News: PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
PRAC, Last updated: 04/09/2020 -
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News: EMA finds no evidence linking viral vector in Zynteglo to blood cancer
PRAC, Last updated: 09/07/2021 -
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News: EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
CHMP, PDCO, PRAC, Last updated: 04/10/2021 -
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News: EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19
CHMP, PDCO, PRAC, Last updated: 18/11/2021 -
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News: EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
CHMP, PRAC, Last updated: 10/01/2022 -
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News: EMA recommends withdrawal of marketing authorisation for amfepramone medicines
PRAC, Last updated: 10/06/2022 -
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News: Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma
PRAC, Last updated: 08/07/2022 -
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News: PRAC starts review of topiramate use in pregnancy and women of childbearing potential
PRAC, Last updated: 02/09/2022 -
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News: Review of pholcodine medicines started
PRAC, Last updated: 02/09/2022 -
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News: New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome
PRAC, Last updated: 30/09/2022