Vaccine to be used only when there is a significant chikungunya risk and after careful consideration of the benefits and risks EMA’s safety committee (PRAC) has completed its…, Agenda Agenda of the PRAC meeting 7-10 July 2025DraftReference…
EMA’s safety committee (PRAC) has completed its review of Ixchiq (a live attenuated chikungunya vaccine), following reports of serious side effects.The previous temporary…
EMA’s human medicines committee (CHMP) has started a review of medicines containing sodium oxybate used in people with alcohol dependency to treat alcohol withdrawal syndrome and…, Contact point Media enquiriesTel. +31 (0)88 781 8427E-mail…
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Zemcelpro (dorocubicel / unexpanded umbilical cord cells) to treat adults…
13 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its June 2025 meeting.The committee recommended granting a…, CHMP statistics Key figures from the June 2025 CHMP…
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Rezdiffra (resmeritom) for the treatment of adults with noncirrhotic metabolic…
EMA has issued a positive opinion for the approval of a vaccine named Biobhyo, indicated to protect pigs from swine dysentery, a disease that causes dysenteric diarrhoea in pigs.…
This news announcement was revised on 13 June 2025 to delete the reference to the European Commission issuing a legally binding decision on the procedure., EMA’s safety committee (PRAC) has concluded its review of medicines containing…
The Committee re-elected Dr Frida Hasslung Wikström from Sweden as its Vice-chair for a further 3-year mandate.CVMP opinions on veterinary medicinal productsThe Committee adopted…
EMA’s annual report 2024 published today gives insights into the Agency’s strategic priorities and contributions to public and animal health in the European Union (EU).The digital…
PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicinesTreatment with semaglutide should be stopped if NAION occursEMA’s safety committee (PRAC) has…, Agenda Agenda of the PRAC meeting 2-5 June…
The European Medicines Agency (EMA) is closed from 18:00 on Friday 6 June 2025 until 08:30 on Tuesday 10 June 2025.The product emergency hotline is available outside working hours…
EMA has released for public consultation a new guideline providing recommendations on how to include and/or retain pregnant and breastfeeding people in clinical trials. The goal…
The European Medicines Agency (EMA) is closed from 18:00 on Wednesday 28 May 2025 until 08:30 on Monday 2 June 2025.The product emergency hotline is available outside working…
Ten new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended ten medicines for approval at its May 2025 meeting.The committee recommended granting…, Positive recommendations on new medicines , Aucatzyl…
EMA’s human medicines committee (CHMP) has recommended several changes to the way the antibiotic azithromycin is used in the EU, including the removal of certain indications.…
EMA’s human medicines committee (CHMP) has started a review of medicines containing ipidacrine. These medicines have been authorised in several EU countries through national…
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Aucatzyl (obecabtagene autoleucel) to treat adults from 26 years of age with…
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 opinion…
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 2025DraftReference…
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…
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…
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…
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…