Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0339/2023

Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0295/2023

Opinion/decision on a Paediatric investigation plan (PIP): Sivextro, tedizolid phosphate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0340/2023

Opinion/decision on a Paediatric investigation plan (PIP): Mysimba, bupropion hydrochloride,naltrexone hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0294/2023

Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva, Obeticholic acid, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: P/0287/2023

Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0309/2023

Opinion/decision on a Paediatric investigation plan (PIP): Eliquis, Apixaban, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: P/0338/2023

Human medicines European public assessment report (EPAR): Viekirax, ombitasvir,paritaprevir,ritonavir, Date of authorisation: 14/01/2015, Revision: 28, Status: Withdrawn (authorisation)

Human medicines European public assessment report (EPAR): Exviera, dasabuvir, Date of authorisation: 14/01/2015, Revision: 26, Status: Withdrawn (authorisation)

PSUSA/00010583/202401