EMEA-002474-PIP02-18-M02

Opinion/decision on a Paediatric investigation plan (PIP): Orladeyo, Berotralstat, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0151/2024

Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra, influenza vaccine (surface antigen, inactivated, prepared in cell cultures) [QIVc], decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0168/2024

Opinion/decision on a Paediatric investigation plan (PIP): Trimbow, beclometasone dipropionate,formoterol fumarate dihydrate,glycopyrronium bromide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Respiratory, thoracic and mediastinal disorders, PIP number: P/0167/2024

Opinion/decision on a Paediatric investigation plan (PIP): Tecartus, brexucabtagene autoleucel, 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/0176/2024

Standard for exchange of non-clinical data (SEND): proof-of-concept study

Questions and answers about the SEND proof-of-concept for industry: Scope, terms of participation and data submission process

EMEA-001716-PIP07-22-M01

EMEA-001666-PIP02-21-M01

Questions and answers for biological medicinal products