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 formulation
  • 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
• Compliance check done:
  Yes
• Compliance procedure number:
  EMA/PE/0000223759
• Compliance opinion date:
  18/10/2024
• Compliance outcome:
  Positive

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)

Adopted Reference Number: EMA/167583/2024