Press release

18.11.2021 To the attention of interested persons EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with […]

Press release

17.11.2021 To the attention of interested persons EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid download […]

Important notification

15.11.2021 To the attention of Romanian manufacturers of medical devices UDI/Device registration – in EUDAMED The new EU regulations of […]

Press release

10.11.2021 To the attention of interested persons EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to […]

Press release

08.11.2021 To the attention of interested persons COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir; EMA starts review […]

Press release

02.11.2021 To the attention of interested persons EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following […]

Press release

02.11.2021 To the attention of interested persons Questions and answers on end of rolling review for antibodies bamlanivimab and etesevimab […]

Press release

29.10.2021 To the attention of interested persons Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021 download […]

Press release

25.10.2021 To the attention of interested persons Spikevax: EMA recommendation on booster download document …

Press release

25.10.2021 To the attention of interested persons COVID-19: EMA starts rolling review of molnupiravir download document …