MHRA-100238-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • AVELUMAB
Invented Name
  • Bavencio
  • Bavencio
  • Bavencio
  • Bavencio
PIP Number MHRA-100238-PIP01-21-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of malignant neoplasms of the central nervous system
  • Treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of the lymphoid tissue.
Route(s) of administration
Route(s) of administration:
  • intravenous
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):AVELUMAB.pdf
Published Date 29/11/2024