News

PRAC July 2026: new safety recommendations for desogestrel- and etonogestrel-containing contraceptives and for Litfulo

During its July 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata.

Update of document on approval dates for variations, renewals and notifications for medicinal products for human use

The document concerning the approval date for variations, renewals and notifications has recently been updated. The changes include a clearer distinction between the revision date and the approval date in the product information for medicinal products for human use.

Limited availability of Azactam 1 g and 2 g powder for solution for injection/infusion: recommendations for specialist doctors and hospital pharmacists

Due to supply issues, Azactam 1 g and Azactam 2 g powder for solution for injection/infusion are currently only available in very limited quantities on the Belgian market. The available stock is not sufficient to meet patients’ needs during the expected period of shortage. Production is not expected to resume before July 2027. The FAMHP's task force on Unavailability issues recommendations.