EMA/PE/0000236704 - paediatric investigation plan

nucresiran

Key facts

• Active substance:
  nucresiran
• Therapeutic area:
  Immune system disorders
• Decision number:
  EMA/PE/0000236704
• PIP number:
  EMA/PE/0000236704
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of transthyretin amyloidosis (ATTR)
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/05/2025
• Compliance check done:
  No

Decision

EMA/PE/0000236704 : EMA decision of 16 May 2025 on the granting of a product specific waiver for nucresiran

Adopted Reference Number: EMADOC-1700519818-2113809