Human medicines European public assessment report (EPAR): Hexyon, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 34, Status: Authorised

PRIME eligibility requests: 2026 deadlines for submission and timetable for assessment

Human medicines European public assessment report (EPAR): Hexacima, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR): Spravato, esketamine, Date of authorisation: 18/12/2019, Revision: 16, Status: Authorised

Management Board formally approves renewal of Executive Director’s mandate

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Human medicines European public assessment report (EPAR): Hemlibra, emicizumab, Date of authorisation: 23/02/2018, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR): Tasmar, tolcapone, Date of authorisation: 27/08/1997, Revision: 26, Status: Authorised

Minutes of the PRAC meeting 7-10 July 2025

PSUSA/00010987/202501