Important notification

18.05.2021 To the attention of stakeholders The unique identification system of medical devices (UDI), in accordance with Regulations (EU) 2017/745 […]

Press release

07.05.2021 To the attention of interested persons Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021. download […]

Press release

07.05.2021 To the attention of interested persons EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19. download document …

Press release

04.05.2021 To the attention of interested persons EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen. […]

Press release

28.04.2021 To the attention of interested persons AstraZeneca’s COVID-19 vaccine: benefits and risks in context. download document …

Press release

28.04.2021 To the attention of interested persons Annex to Vaxzevria Art.5.3 – Visual risk contextualisation. download document …

Press release

21.04.2021 To the attention of interested persons COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual […]

Press release

15.04.2021 To the attention of interested persons COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with […]

Press release

15.04.2021 To the attention of interested persons AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare […]

Press release

09.04.2021 To the attention of interested persons Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021 download […]