EMEA-001949-PIP02-18-M05
EMEA-001949-PIP02-18-M05
EMEA-001949-PIP02-18-M05
Opinion/decision on a Paediatric investigation plan (PIP): Ontozry, cenobamate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0279/2024
Opinion/decision on a Paediatric investigation plan (PIP): Xospata, Gilteritinib (as fumarate), 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/0289/2024
EMEA-002479-PIP01-18-M02
EMEA-002942-PIP02-20-M02
EMEA-002706-PIP01-19-M03
Opinion/decision on a Paediatric investigation plan (PIP): Vafseo, vadadustat, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders, PIP number: P/0290/2024
EMEA-002246-PIP01-17-M05
EMEA-001855-PIP01-15-M06
Pilot participation letter: Clinical study data proof-of-concept