Human medicines European public assessment report (EPAR): Zessly, infliximab, Date of authorisation: 18/05/2018, Revision: 15, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Zejula, niraparib (tosilate monohydrate), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0229/2024

EMEA-002021-PIP01-16-M01

Human medicines European public assessment report (EPAR): Korjuny, catumaxomab, Date of authorisation: 10/02/2025, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Tolucombi, telmisartan,hydrochlorothiazide, Date of authorisation: 13/03/2013, Revision: 12, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Namuscla, Mexiletine hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0227/2024

Human medicines European public assessment report (EPAR): Beyfortus, nirsevimab, Date of authorisation: 31/10/2022, Revision: 12, Status: Authorised

EMEA-002169-PIP01-17-M03

Public event: advancing regulatory science research, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 November 2024, 13:30 (CET) to 18 November 2024, 17:30 (CET)

EMEA-003598-PIP01-24