Paediatric investigation plans: questions and answers

Timetable: Annual reassessment

Timetable: Marketing authorisation renewal application

PSUSA/00010270/202411

Human medicines European public assessment report (EPAR): Sugammadex Mylan, sugammadex, Date of authorisation: 15/11/2021, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Ozempic, semaglutide, Date of authorisation: 08/02/2018, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR): Crysvita, burosumab, Date of authorisation: 19/02/2018, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Javlor, vinflunine, Date of authorisation: 21/09/2009, Revision: 12, Status: Authorised

Scientific and technical recommendations: Veterinary Medicines Regulation

Human medicines European public assessment report (EPAR): Opuviz, aflibercept, Date of authorisation: 13/11/2024, Revision: 2, Status: Authorised