EMEA-000069-PIP01-07-M09 - paediatric investigation plan

Mepolizumab

Key facts

• Invented name:
  Nucala
• Active substance:
  Mepolizumab
• Therapeutic area:
  Immune system disorders
• Decision number:
  P/0367/2024
• PIP number:
  EMEA-000069-PIP01-07-M09
• Pharmaceutical form(s):
  • Powder for solution for infusion
  • Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  Treatment of hypereosinophilic syndrome
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

P/0367/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab (Nucala), (EMEA-000069-PIP01-07-M09)

Adopted Reference Number: EMA/465524/2024