EMEA-002007-PIP02-17-M03 - paediatric investigation plan

cemiplimab

Key facts

• Invented name:
  Libtayo
• Active substance:
  cemiplimab
• Therapeutic area:
  Oncology
• Decision number:
  P/0414/2023
• PIP number:
  EMEA-002007-PIP02-17-M03
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions included 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:
  27/10/2023
• Compliance check done:
  Ne

Decision

P/0414/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for cemiplimab (Libtayo), (EMEA-002007-PIP02-17-M03)

Adopted Reference Number: EMA/430045/2023