Opinion/decision on a Paediatric investigation plan (PIP): Padcev, Enfortumab vedotin, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Oncology, PIP number: P/0385/2023

EMEA-001973-PIP02-23

Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Dermatology, PIP number: P/0383/2023

Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Uro-nephrology, PIP number: P/0388/2023

Opinion/decision on a Paediatric investigation plan (PIP): Braftovi, Encorafenib, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Oncology, PIP number: P/0351/2023

Opinion/decision on a Paediatric investigation plan (PIP): Mektovi, binimetinib, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Oncology, PIP number: P/0349/2023

EMEA-001573-PIP03-23

Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0345/2023

Product-information requirements

Questions and answers on labelling requirements for centrally authorised metered dose inhalers containing fluorinated greenhouse gases