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

Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir,cobicistat, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0257/2023

Opinion/decision on a Paediatric investigation plan (PIP): Imlygic, talimogene laherparepvec, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0275/2023

Opinion/decision on a Paediatric investigation plan (PIP): Imvanex, Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0284/2023

Opinion/decision on a Paediatric investigation plan (PIP): Taltz, ixekizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0049/2023

Opinion/decision on a Paediatric investigation plan (PIP): Kevzara, sarilumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0258/2023

Human medicines European public assessment report (EPAR): Palynziq, pegvaliase, Date of authorisation: 03/05/2019, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): DaTSCAN, ioflupane (123l), Date of authorisation: 27/07/2000, Revision: 25, Status: Authorised

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024

Human medicines European public assessment report (EPAR): Invega, paliperidone, Date of authorisation: 24/06/2007, Revision: 19, Status: Authorised