www.ema.europa.eu The European Medicines Agency's (EMA) office is closed from 18:30 on Wednesday 5 April 2023 to 07:30 on Tuesday 11 April 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...

www.ema.europa.eu EMA has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2023.Manufacturers of egg-based or live attenuated quadrivalent vaccines for the 2023-2024 season...

www.ema.europa.eu The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2023.Every year, the European Commission adopts a regulation...

www.ema.europa.eu Nine new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended nine medicines for approval at its March 2023 meeting.The CHMP recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people...

www.ema.europa.eu EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and above who have been vaccinated with an mRNA COVID-19 vaccine.Bimervax, developed by HIPRA Human...

www.ema.europa.eu DARWIN EU®, the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination Centre in February 2022, the first ten data partners were onboarded. The network also initiated its...