EMEA-000069-PIP01-07-M07 - paediatric investigation plan

Mepolizumab

Key facts

• Invented name:
  Nucala
• Active Substance:
  Mepolizumab
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0384/2020
• PIP number:
  EMEA-000069-PIP01-07-M07
• 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:
  23/09/2020

Decision

P/0384/2020: EMA decision of 23 September 2020 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab (Nucala) (EMEA-000069-PIP01-07-M07)

AdoptedReference Number: EMA/487753/2020