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News: EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19 (new)
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 (new)
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 (new)
PRAC, Last updated: 01/10/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 September 2021 (new)
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 (new)
PRAC, Last updated: 22/09/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021 (updated)
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 -
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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: EMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary leak syndrome
PRAC, Last updated: 09/07/2021 -
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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: Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis
PRAC, Last updated: 09/07/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021
PRAC, Last updated: 11/06/2021 -
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News: COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis
PRAC, Last updated: 11/06/2021 -
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News: Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
PRAC, Last updated: 11/06/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021
PRAC, Last updated: 07/05/2021 -
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News: COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
PRAC, Last updated: 20/04/2021 -
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News: COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
PRAC, Last updated: 14/04/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
PRAC, Last updated: 09/04/2021 -
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News: AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
PRAC, Last updated: 07/04/2021 -
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News: AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues
PRAC, Last updated: 31/03/2021 -
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News: COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases
PRAC, Last updated: 25/03/2021 -
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News: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets
PRAC, Last updated: 19/03/2021 -
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News: Investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events continues
PRAC, Last updated: 16/03/2021 -
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News: EMA’s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update
PRAC, Last updated: 15/03/2021