EMA/PE/0000223498 - paediatric investigation plan

Infigratinib

Key facts

• Active substance:
  Infigratinib
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000223498
• PIP number:
  EMA/PE/0000223498
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of achondroplasia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2025
• Compliance check done:
  Nein

Decision

EMA/PE/0000223498 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for infigratinib

Adopted Reference Number: EMADOC-1700519818-1810197