EMEA-002209-PIP01-17-M03 - paediatric investigation plan

Setmelanotide

Key facts

• Invented name:
  Imcivree
• Active Substance:
  Setmelanotide
• Therapeutic area:
  Nutrition
• Decision number:
  P/0348/2022
• PIP number:
  EMEA-002209-PIP01-17-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of appetite and general nutrition disorders
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Rhythm Pharmaceuticals, Inc

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/08/2022

Decision

P/0348/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for setmelanotide (Imcivree) (EMEA-002209-PIP01-17-M03)

AdoptedReference Number: EMA/672726/2022