www.ema.europa.eu The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement on adapted COVID-19 vaccines and considerations for their use during the upcoming autumn 2023 vaccination campaigns. Currently authorised...

www.ema.europa.eu Today, the European Union (EU) and the United States (US) have made important progress towards enabling mutual recognition of inspections of manufacturing facilities of certain veterinary products. The Food and Drug Administration (FDA) has recognised the capability of 16...

www.ema.europa.eu International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and the need for and strategy to update their composition based on the emerging evidence on coronavirus SARS-CoV-2 variants and lessons learned from...

www.ema.europa.eu The European Medicines Agency's (EMA) office is closed on Monday 29 May 2023.Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number and should only be used in...

www.ema.europa.eu Two new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended two medicines for approval at its May 2023 meeting.The committee recommended granting a marketing authorisation for Pylclari (piflufolastat (18F)), intended for the diagnosis of...

www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises) in patients aged 16 years and older with sickle cell disease.This follows a...