EMEA-002544-PIP01-18-M02 - paediatric investigation plan

Selpercatinib

Key facts

• Invented name:
  Retsevmo
• Active Substance:
  Selpercatinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0133/2023
• PIP number:
  EMEA-002544-PIP01-18-M02
• Pharmaceutical form(s):
  • Capsule, hard
  • Age-appropriate dosage form
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/04/2023

Decision

P/0133/2023 : EMA decision of 13 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for selpercatinib (Retsevmo), (EMEA-002544-PIP01-18-M02)

Reference Number: EMA/146941/2023