EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting.The committee recommended granting a marketing authorisation …, Positive recommendations on new medicines , Balversa Common name…
EMA has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (…
EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Translarna (ataluren), a medicine for treating patients with…
EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to tackle…, “We need to step up actions now - industry, regulators,…
The Committee adopted by consensus a positive opinion for a marketing authorisation for DIVENCE IBR Marker Live from Laboratorios Hipra, S.A., a new vaccine intended for the…
The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European…
EMA has started a review of medicines containing the painkiller metamizole following concerns that the measures in place to minimise the known risk of agranulocytosis may not be…
Review of painkiller metamizole startedReview will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections, and measures to…, Agenda Agenda of the PRAC meeting 13-16 May 2024DraftReference…
Positive assessment of EMA’s activities in 2023The Management Board assessed and adopted the Executive Director’s annual activity report for 2023. The report describes the…
The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching two advice pilots aimed at improving the quality of applications for clinical trials, the…
The news announcement was updated on 3 June 2024 to include a recommendation for seasonal live attenuated influenza vaccine strains and updated information for a strain for cell-…, EMA has issued recommendations for the influenza virus…
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its May 2024 meeting.The CHMP recommended granting a marketing authorisation under exceptional…, Positive recommendations on new medicines , Adzynma Common…
EMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and older against Chikungunya…
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe…
EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the European Union (EU). With a fresh layout and new interactive…
CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation for Nobilis Multriva RT+IBm+ND+EDS, from…
Update as of 21 May 2024The European Commission has asked the CHMP to review its January opinion on the renewal of the marketing authorisation for Translarna. The CHMP will now…
A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer…
EMA has launched its biennial communication perception survey. The purpose of the survey is to collect feedback on EMA’s external communications from patients, consumers,…
This means that the network, composed of the European Commission, EMA and the 30 national authorities of the European Economic Area Member States, are recognised as meeting…
EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European…
Hydroxyprogesterone caproate medicines to be suspended from the EU marketEMA’s safety committee (PRAC) has recommended the suspension of the marketing authorisations for medicines…, Agenda Agenda of the PRAC meeting 13-16 May…
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…
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…
One Health recognises the complex interplay between human, animal and plant health, food safety, the climate crisis and environmental sustainability. Implementing this approach…
EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign.JN.1 differs from the…
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…
This new partnership between the two regulatory authorities is an important step towards mutual recognition and regulatory harmonisation to improve human and animal…
Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.The CHMP recommended granting…, Positive recommendations on new medicines ,…
These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which…