Opinion/decision on a Paediatric investigation plan (PIP): Pombiliti, Cipaglucosidase alfa, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: EMA/PE/0000223351

EMA/PE/0000223288

EMA/PE/0000222938

EMEA-003219-PIP01-22

PSUSA/00001855/202505

Withdrawn application: Scenesse, 24/04/2024

Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin), insulin glargine, Date of authorisation: 26/06/2000, Revision: 38, Status: Authorised

Human medicines European public assessment report (EPAR): Apidra, insulin glulisine, Date of authorisation: 27/09/2004, Revision: 35, Status: Authorised

Human medicines European public assessment report (EPAR): VacPertagen, pertussis vaccine (recombinant, acellular, component, adsorbed), Date of authorisation: 09/01/2026, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Lantus, insulin glargine, Date of authorisation: 09/06/2000, Revision: 43, Status: Authorised