Opinion/decision on a Paediatric investigation plan (PIP): Vimpat, lacosamide, decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0470/2023

EMEA-000325-PIP01-08-M11

Opinion/decision on a Paediatric investigation plan (PIP): Saxenda, liraglutide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrine disorders, PIP number: P/0468/2023

Opinion/decision on a Paediatric investigation plan (PIP): Xydalba, dalbavancin hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0467/2023

Opinion/decision on a Paediatric investigation plan (PIP): Lutathera, lutetium (177Lu) oxodotreotide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0461/2023

Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiac disorders, PIP number: P/0457/2023

Human medicines European public assessment report (EPAR): Dynastat, parecoxib, Date of authorisation: 22/03/2002, Revision: 39, Status: Authorised

Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 9, Status: Authorised

List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)

Veterinary medicines European public assessment report (EPAR): Bluevac-3, bluetongue virus vaccine (inactivated), Status: Authorised