List of medicinal products under additional monitoring
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
Sodium salicylate (poultry other than turkey): European Public MRL Assessment Report (EPMAR) - CVMP