Opinion/decision on a Paediatric investigation plan (PIP): Besponsa,Inotuzumab ozogamicin, decision type: , therapeutic area: , PIP number: P/0398/2022

Opinion/decision on a Paediatric investigation plan (PIP): Tremfya,Guselkumab, decision type: , therapeutic area: , PIP number: P/0399/2022

Opinion/decision on a Paediatric investigation plan (PIP): Roxadustat, decision type: , therapeutic area: , PIP number: P/0400/2022

Opinion/decision on a Paediatric investigation plan (PIP): Descovy,emtricitabine,tenofovir alafenamide, decision type: , therapeutic area: , PIP number: P/0402/2022

Opinion/decision on a Paediatric investigation plan (PIP): Epcoritamab, decision type: , therapeutic area: , PIP number: P/0415/2022

Orphan designation: Celecoxib,Ciprofloxacin, Treatment of amyotrophic lateral sclerosis, 06/01/2021, Positive

Human medicines European public assessment report (EPAR): Steglujan, ertugliflozin,sitagliptin, Diabetes Mellitus, Type 2, Date of authorisation: 23/03/2018, Revision: 11, Status: Authorised

Committee for Advanced Therapies (CAT): 12-14 July 2023, European Medicines Agency, Amsterdam, the Netherlands, from 12/07/2023 to 14/07/2023

Human medicines European public assessment report (EPAR): Tesavel, sitagliptin, Diabetes Mellitus, Type 2, Date of authorisation: 10/01/2008, Revision: 28, Status: Authorised

Human medicines European public assessment report (EPAR): Veyvondi, vonicog alfa, von Willebrand Diseases, Date of authorisation: 31/08/2018, Revision: 8, Status: Authorised