EMEA-001585-PIP01-13-M06 - paediatric investigation plan

Selumetinib

Key facts

• Invented name:
  Koselugo
• Active Substance:
  Selumetinib
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0134/2024
• PIP number:
  EMEA-001585-PIP01-13-M06
• 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:
  25/04/2024

Decision

P/0134/2024: EMA decision of 25 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for selumetinib (Koselugo) (EMEA-001585-PIP01-13-M06)

AdoptedReference Number: EMA/167583/2024