EMEA-000534-PIP03-17-M01 - paediatric investigation plan

Mecasermin rinfabate

Key facts

• Active Substance:
  Mecasermin rinfabate
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0187/2024
• PIP number:
  EMEA-000534-PIP03-17-M01
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Prevention of chronic lung disease of prematurity
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2024

Decision

P/0187/2024 - EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mecasermin rinfabate (EMEA-000534-PIP03-17-M01)

AdoptedReference Number: EMA/251730/2024