EMEA-003525-PIP01-23 - paediatric investigation plan

mirdametinib

Key facts

• Active Substance:
  mirdametinib
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0223/2024
• PIP number:
  EMEA-003525-PIP01-23
• Pharmaceutical form(s):
  • Capsule, hard
  • Tablet
• Condition(s) / indication(s):
  Treatment of neurofibromatosis type 1
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  20/06/2024

Decision

P/0223/2024 : EMA decision of 20 June 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for mirdametinib (EMEA-003525-PIP01-23)

AdoptedReference Number: EMA/284186/2024