EMA/PE/0000239753 - paediatric investigation plan

maridebart cafraglutide

Key facts

• Active substance:
  maridebart cafraglutide
• Therapeutic area:
  Surgical and medical procedures
• Decision number:
  EMA/PE/0000239753
• PIP number:
  EMA/PE/0000239753
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  24/04/2025
• Compliance check done:
  No

Decision

EMA/PE/0000239753 : EMA decision of 24 April 2025 on the granting of a product specific waiver for maridebart cafraglutide

Adopted Reference Number: EMADOC-1700519818-2068841