Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)

Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs)

Human medicines European public assessment report (EPAR): Alyftrek, deutivacaftor / tezacaftor / vanzacaftor, Date of authorisation: 30/06/2025, Status: Authorised

Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (22 August 2025 - 18 September 2025)

Request to the CVMP for classification of a veterinary medicinal product as intended for a limited market according to Article 4(29) and for eligibility for authorisation according to Article 23 (Applications for limited markets)

Engineered living materials for in situ production of therapeutics - EU-IN Horizon Scanning Report

Human medicines European public assessment report (EPAR): Gilenya, fingolimod, Date of authorisation: 17/03/2011, Revision: 39, Status: Authorised

Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Date of authorisation: 22/08/2014, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Pelmeg, pegfilgrastim, Date of authorisation: 20/11/2018, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma), pegfilgrastim, Date of authorisation: 19/12/2019, Revision: 9, Status: Authorised