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EMEA-001849-PIP02-15-M04 - paediatric investigation plan
avelumab
PIPHuman
Key facts
Invented name
Bavencio
Bavencio
Active Substance
avelumab
Therapeutic area
Oncology
Decision number
P/0546/2021
PIP number
EMEA-001849-PIP02-15-M04
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
Treatment of malignant neoplasms of lymphoid tissue
Treatment of malignant neoplasms of the central nervous system
PM: decision on the application for modification of an agreed PIP
Decision date
Decision
P/0546/2021: EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for avelumab (Bavencio), (EMEA-001849-PIP02-15-M04)