EMEA-001585-PIP01-13-M05 - paediatric investigation plan

Selumetinib

Key facts

• Active Substance:
  Selumetinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0341/2021
• PIP number:
  EMEA-001585-PIP01-13-M05
• Pharmaceutical form(s):
  • Age-appropriate oral dosage form
  • Capsule, hard
• Condition(s) / indication(s):
  • Treatment of melanoma
  • Treatment of neurofibromatosis type 1
  • Treatment of thyroid cancer
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/08/2021

Decision

P/0341/2021 : EMA decision of 12 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for selumetinib (EMEA- 001585-PIP01-13-M05)

AdoptedReference Number: EMA/438008/2021