List of medicinal products under additional monitoring

List of medicinal products under additional monitoring

National registers of authorised medicines

EU 4 AMA: leveraging European expertise for medicines regulation in Africa

EMEA-002427-PIP01-18-M02

Opinion/decision on a Paediatric investigation plan (PIP): Zynrelef, bupivacaine,meloxicam (HTX-011), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pain, PIP number: P/0160/2023

EMEA-002233-PIP01-17-M02

EMEA-002166-PIP01-17-M07

Opinion/decision on a Paediatric investigation plan (PIP): Odefsey, emtricitabine,rilpivirine,tenofovir alafenamide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0193/2023

Opinion/decision on a Paediatric investigation plan (PIP): Reagila, Cariprazine (hydrochloride), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Psychiatry, PIP number: P/0162/2023