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News: EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17 (new)
CHMP, PDCO, Last updated: 23/06/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022 (new)
PRAC, Last updated: 10/06/2022 -
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News: EMA recommends withdrawal of marketing authorisation for amfepramone medicines (new)
PRAC, Last updated: 10/06/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022
PRAC, Last updated: 06/05/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022
PRAC, Last updated: 08/04/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
PRAC, Last updated: 11/03/2022 -
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News: EMA recommends approval of Spikevax for children aged 6 to 11
CHMP, PDCO, Last updated: 24/02/2022 -
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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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News: EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
PRAC, Last updated: 11/02/2022 -
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News: PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
PRAC, Last updated: 11/02/2022 -
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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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News: COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
CHMP, PRAC, Last updated: 18/01/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022
PRAC, Last updated: 14/01/2022 -
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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: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021
PRAC, Last updated: 03/12/2021 -
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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: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
PRAC, Last updated: 29/10/2021 -
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News: EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
CHMP, PDCO, PRAC, Last updated: 11/10/2021 -
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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 starts review of meningioma risk with nomegestrol- and chlormadinone-containing medicines
PRAC, Last updated: 01/10/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 September 2021
PRAC, Last updated: 01/10/2021 -
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News: Call for expressions of interest for civil society representatives to participate in work of EMA
PRAC, Last updated: 27/10/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
PRAC, Last updated: 17/09/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
PRAC, Last updated: 06/08/2021 -
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News: COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect
PRAC, Last updated: 22/07/2021