Agenda of the PRAC meeting 13-16 May 2024

Human medicines European public assessment report (EPAR): Ghryvelin (previously Macimorelin Aeterna Zentaris), macimorelin, Date of authorisation: 11/01/2019, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Anagrelide Viatris (previously Anagrelide Mylan), anagrelide, Date of authorisation: 15/02/2018, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Onglyza, saxagliptin, Date of authorisation: 30/09/2009, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Rasagiline Mylan, rasagiline, Date of authorisation: 04/04/2016, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Plerixafor Accord, plerixafor, Date of authorisation: 16/12/2022, Revision: 2, Status: Authorised

CVMP recommendations on limited market classification and eligibility for authorisation under Article 23

Timetable: Post-authorisation safety study (PASS) protocols and final results

Timetable: Initial (Full) marketing authorisation application - ATMP

Organisation chart: Advisory functions