Work programme for 2025The Management Board adopted EMA’s work programme for 2025, which outlines how the Agency will adapt to the rapidly evolving medicines landscape and prepare…

EMA has recommended granting a marketing authorisation in the European Union (EU) for Emcitate (tiratricol), an oral treatment for peripheral thyrotoxicosis (inappropriately high…

Seventeen new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seventeen medicines for approval at its December 2024 meeting. This brings the…, Positive recommendations on new medicines , […]

EMA has recommended extending the indication of Ofev (nintedanib) to include the treatment of progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents…

CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a marketing authorisation application for Icthiovac ERM from …

Doxycycline: currently available evidence not supporting link with risk of suicidalityEMA’s safety committee (PRAC) has concluded that the currently available evidence is not…, Agenda Agenda of the PRAC meeting 25-28 November […]

The European Shortages Monitoring Platform (ESMP) has gone live with a core set of functionalities. Using this first version of the ESMP, marketing authorisation holders (MAHs)…,

EMA is advising marketing authorisation holders to submit type IA and type IAINvariations for 2024 no later than 30 November 2024. This will enable EMA to acknowledge the…

Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2024 meeting.The committee recommended…, Positive recommendations on new medicines , […]

EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2024 no later than 30 November 2024. This will enable EMA to acknowledge the…, Related documents European Medicines Agency practical […]