www.ema.europa.eu PRAC agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata Desogestrel- and etonogestrel-containing medicines: risk of meningioma and new measures to minimise this risk PRAC agreed on a...
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2026 – www.ema.europa.eu
www.ema.europa.eu PRAC agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata Desogestrel- and etonogestrel-containing medicines: risk of meningioma and new measures to minimise this risk PRAC agreed on a...
EMA fast tracks review of a medicine for metastatic pancreatic cancer – www.ema.europa.eu
www.ema.europa.eu EMA’s human medicines committee (CHMP) has started a phased review of data on daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer. A phased review aims to accelerate the assessment of a medicine by evaluating the data in phases, as they...
EMA steps up efforts on medicines for women’s health – www.ema.europa.eu
www.ema.europa.eu EMA’s initiatives in this area will be discussed through a dedicated women’s health workshop on 28-29 September. The workshop, broadcast live, will take stock of current activities across the EU, including from EMA, national regulators and other organisations. It will...
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2026 – www.ema.europa.eu
www.ema.europa.eu Six new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended six medicines for approval at its June 2026 meeting. The committee recommended granting a marketing authorisation for Aujemflu (influenza virus surface antigens (haemagglutinin...
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 June 2026 – www.ema.europa.eu
www.ema.europa.eu CVMP opinions on veterinary medicinal products The Committee adopted a negative opinion for a marketing authorisation for Scovella (velagliflozin), a product classified as intended for a limited market, for the treatment of hyperinsulinaemia and associated clinical signs...