EMEA-002007-PIP02-17-M02 - paediatric investigation plan

Cemiplimab

Key facts

• Invented name:
  Libtayo
• Active Substance:
  Cemiplimab
• Therapeutic area:
  Oncology
• Decision number:
  P/0179/2022
• PIP number:
  EMEA-002007-PIP02-17-M02
• 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
• Contact for public enquiries:

  Regeneron Ireland DAC

  E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/05/2022

Decision

P/0179/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cemiplimab (Libtayo), (EMEA-002007-PIP02-17-M02)

AdoptedReference Number: EMA/205775/2022