EMEA-002689-PIP02-23 - paediatric investigation plan

navepegritide

Key facts

• Active Substance:
  navepegritide
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0082/2024
• PIP number:
  EMEA-002689-PIP02-23
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/03/2024

Decision

P/0082/2024 : EMA decision of 15 March 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for navepegritide (EMEA-002689-PIP02-23)

AdoptedReference Number: EMA/103594/2024