EMA/PE/0000221709 - paediatric investigation plan

apitegromab

Key facts

• Active substance:
  apitegromab
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000221709
• PIP number:
  EMA/PE/0000221709
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of spinal muscular atrophy
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/11/2024
• Compliance check done:
  Nej

Decision

EMA/PE/0000221709: EMA decision of 7 November 2024 on the acceptance of a modification of an agreed paediatric investigation plan for apitegromab

Adopted Reference Number: EMADOC-1700519818-1736438