EMEA-002689-PIP02-23-M01 - paediatric investigation plan

navepegritide

Key facts

• Active substance:
  navepegritide
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0275/2024
• PIP number:
  EMEA-002689-PIP02-23-M01
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of achondroplasia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/08/2024
• Compliance check done:
  Nie

Decision

P/0275/2024: EMA decision of 14 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for navepegritide (EMEA-002689-PIP02-23-M01)

Adopted Reference Number: EMA/307239/2024