EMEA-002951-PIP02-21 - paediatric investigation plan

Apitegromab

Key facts

• Active Substance:
  Apitegromab
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0014/2024
• PIP number:
  EMEA-002951-PIP02-21
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of spinal muscular atrophy
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2024

Decision

P/0014/2024 : EMA decision of 31 January 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for apitegromab (EMEA-002951-PIP02-21)

AdoptedReference Number: EMA/15341/2024