Pilot participation letter: Clinical study data proof-of-concept

Opinion/decision on a Paediatric investigation plan (PIP): Dovprela (previously Pretomanid FGK), Pretomanid, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0295/2024

Opinion/decision on a Paediatric investigation plan (PIP): Bavencio, avelumab, 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/0312/2024

EMEA-002700-PIP01-19-M02

Opinion/decision on a Paediatric investigation plan (PIP): Symtuza, darunavir,cobicistat,emtricitabine,tenofovir alafenamide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0284/2024

Opinion/decision on a Paediatric investigation plan (PIP): Voxzogo, vosoritide, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0286/2024

Opinion/decision on a Paediatric investigation plan (PIP): Juluca, rilpivirine,dolutegravir, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0283/2024

EMEA-001739-PIP02-16-M02

Opinion/decision on a Paediatric investigation plan (PIP): Tezspire, tezepelumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastrointestinal disorders, PIP number: P/0281/2024

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: Metabolism and nutrition disorders, PIP number: P/0280/2024