EMEA-002463-PIP01-18-M02 - paediatric investigation plan

dostarlimab

Key facts

• Invented name:
  Jemperli
• Active substance:
  dostarlimab
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0260/2024
• PIP number:
  EMEA-002463-PIP01-18-M02
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions contained in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/07/2024
• Compliance check done:
  Nie

Decision

P/0260/2024: EMA decision of 17 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dostarlimab (Jemperli), (EMEA-002463-PIP01-18-M02)

Adopted Reference Number: EMA/328795/2024