EMEA-003635-PIP01-24

Minutes of the PRAC meeting 12 - 15 January 2026

Agenda - Management Board meeting: 12 March 2026

Opinion/decision on a Paediatric investigation plan (PIP): Spravato, esketamine hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Psychiatry, PIP number: EMA/PE/0000224110

Opinion/decision on a Paediatric investigation plan (PIP): Imvanex, Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: EMA/PE/0000223819

EMEA-003119-PIP01-21-M01

EMEA-003604-PIP01-24

Human medicines European public assessment report (EPAR): Vitrakvi, larotrectinib, Date of authorisation: 19/09/2019, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 57, Status: Authorised

EMEA-003161-PIP02-24