EMEA-001701-PIP01-14-M02 - paediatric investigation plan

Metreleptin

Key facts

• Invented name:
  Myalepta
• Active substance:
  Metreleptin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0389/2021
• PIP number:
  EMEA-001701-PIP01-14-M02
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of lipodystrophy
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2021
• Compliance check done:
  No

Decision

P/0389/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for metreleptin (Myalepta), (EMEA-001701-PIP01-14-M02)

Adopted Reference Number: EMA/418723/2021