EMEA-002999-PIP01-21-M01

PSUSA/00010067/202410

Opinion/decision on a Paediatric investigation plan (PIP): Lynparza, Olaparib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0148/2024

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/0138/2024

Human medicines European public assessment report (EPAR): Zerbaxa, ceftolozane,tazobactam, Date of authorisation: 18/09/2015, Revision: 17, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Doptelet, avatrombopag maleate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders;Haematology-Hemostaseology, PIP number: P/0137/2024

Presentation - The summary-of-product-characteristics guideline and paediatric aspects

Eighth European Medicines Agency (EMA) and EFPIA bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 8 July 2025, 15:00 (CEST) to 8 July 2025, 17:00 (CEST)

Opinion/decision on a Paediatric investigation plan (PIP): Jyseleca, filgotinib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Musculoskeletal and connective tissue disorders, PIP number: P/0119/2024

Agenda - Management Board meeting: 11-12 June 2025