Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages

Abbreviation of names of days on calendarised blisters

Human medicines European public assessment report (EPAR): Truqap, capivasertib, Date of authorisation: 17/06/2024, Revision: 3, Status: Authorised

PSUSA/00001029/202503

PSUSA/00010808/202503

Human medicines European public assessment report (EPAR): Tremfya, guselkumab, Date of authorisation: 10/11/2017, Revision: 14, Status: Authorised

Agenda - 1st EMA and European Respiratory Society (ERS) bilateral meeting

Human medicines European public assessment report (EPAR): Piqray, alpelisib, Date of authorisation: 27/07/2020, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib, Date of authorisation: 26/08/2013, Revision: 38, Status: Authorised

Human medicines European public assessment report (EPAR): Vgenfli, aflibercept, Date of authorisation: 14/08/2025, Status: Authorised