EMEA-002635-PIP02-21-M02 - paediatric investigation plan

repotrectinib

Key facts

• Active Substance:
  repotrectinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0335/2023
• PIP number:
  EMEA-002635-PIP02-21-M02
• Pharmaceutical form(s):
  • Age-appropriate oral liquid dosage form
  • Capsule, hard
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic neoplasms)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/08/2023

Decision

P/0335/2023 : EMA decision of 9 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for repotrectinib (EMEA-002635-PIP02-21-M02)

Reference Number: EMA/347489/2023