EMA/PE/0000236239 - paediatric investigation plan

empasiprubart

Key facts

• Active substance:
  empasiprubart
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000236239
• PIP number:
  EMA/PE/0000236239
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of chronic inflammatory demyelinating polyradiculo-neuropathy
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/04/2025
• Compliance check done:
  Nem

Decision

EMA/PE/0000236239: EMA decision of 14 April 2025 on the granting of a product specific waiver for empasiprubart

Adopted Reference Number: EMADOC-1700519818-2038994