EMA/PE/0000223677 - paediatric investigation plan

coramitug

Key facts

• Active substance:
  coramitug
• Therapeutic area:
  Immune system disorders
• Decision number:
  EMA/PE/0000223677
• PIP number:
  EMA/PE/0000223677
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  • Adjunctive treatment in haematopoietic cell transplantation
  • Treatment of transthyretin amyloidosis (ATTR)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000223677 : EMA decision of 28 January 2025 on the granting of a product specific waiver for coramitug

Adopted Reference Number: EMADOC-1700519818-1852851