The Committee re-elected Johan Schefferlie from the Netherlands as its Chair for a further 3-year mandate.CVMP opinions on veterinary medicinal productsThe Committee adopted by…, Maximum residue limits Lidocaine (Porcine) – Summary […]

EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant LP.8.1 for the 2025/2026 vaccination campaign.LP.8.1 differs from…

Review of medicines containing finasteride and dutasteride concluded Finasteride and dutasteride tablets: Measures to minimise risk of suicidal thoughtsFollowing an EU-wide…, Agenda Agenda of the PRAC meeting 5-8 May […]

Following an EU-wide review of available data on finasteride and dutasteride medicines, EMA’s safety committee, PRAC, has confirmed suicidal ideation (suicidal thoughts) as a side…, The product information for finasteride 1 mg tablets will now […]

EMA and the Heads of Medicines Agencies (HMA) have published a joint workplan “Data and AI in medicines regulation to 2028”. It sets out how the European medicines regulatory…, “In view of the technology-driven explosion of data, we need to be […]

EMA’s safety committee (PRAC) has started a review of Ixchiq (a live attenuated chikungunya vaccine) following reports of serious adverse events in elderly people.Many of the…

The European Medicines Agency’s (EMA) office is closed from 18:00 on Thursday 8 May 2025 to 08:30 on Monday 12 May 2025. EMA is hosting its first Open Door Day on Friday…

The European Medicines Agency’s (EMA) office is closed from 18:00 on Wednesday 30 April 2025 to 08:30 on Friday 2 May 2025.Outside of working hours and on public holidays, it…

EMA’s Management Board has unanimously recommended the renewal of its Executive Director Emer Cooke’s mandate. This recommendation was given in response to a consultation request…

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Duvyzat (givinostat) as a treatment for Duchenne muscular dystrophy (DMD) in…

16 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 16 medicines for approval at its April 2025 meeting.The CHMP recommended granting a…, Positive recommendations on new medicines , Alyftrek […]