EMEA-000069-PIP04-13-M02 - paediatric investigation plan

Mepolizumab

Key facts

• Invented name:
  Nucala
• Active substance:
  Mepolizumab
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0300/2018
• PIP number:
  EMEA-000069-PIP04-13-M02
• Pharmaceutical form(s):
  • Powder for solution for injection or infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of vasculitides
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/09/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000069-PIP04-13-M02
• Compliance opinion date:
  28/02/2020
• Compliance outcome:
  Positive

Decision

P/0300/2018: EMA decision of 12 September 2018 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab (Nucala), (EMEA-000069-PIP04-13-M02)

Adopted Reference Number: EMA/538548/2018