EMA/PE/0000182239 - paediatric investigation plan

setmelanotide

Key facts

• Invented name:
  Imcivree
• Active substance:
  setmelanotide
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  EMA/PE/0000182239
• PIP number:
  EMA/PE/0000182239
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of appetite and general nutrition disorders
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  19/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000182239: EMA decision of 19 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for setmelanotide (Imcivree)

Adopted Reference Number: EMADOC-1700519818-1796893