New product information wording – Extracts from PRAC recommendations on signals adopted at the 28-31 October 2024 PRAC

Human medicines European public assessment report (EPAR): Revolade, eltrombopag, Date of authorisation: 11/03/2010, Revision: 39, Status: Authorised

Human medicines European public assessment report (EPAR): Vydura, rimegepant, Date of authorisation: 25/04/2022, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 8, Status: Authorised

EMA/PE/0000226657

Opinion/decision on a Paediatric investigation plan (PIP): Rizmoic, naldemedine tosilate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastrointestinal disorders, PIP number: EMA/PE/0000226303

EMEA-003395-PIP02-23

EMEA-001238-PIP02-20

Veterinary medicines European public assessment report (EPAR): Epizootic haemorrhagic disease vaccine (recombinant protein) Laboratorios Syva S.A., Epizootic haemorrhagic disease vaccine (recombinant protein), Status: Authorised

Fees payable to the European Medicines Agency: Guidance for all applicants