EMEA-000069-PIP02-10-M08 - paediatric investigation plan

Mepolizumab

Key facts

• Invented name:
  Nucala
• Active substance:
  Mepolizumab
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0239/2017
• PIP number:
  EMEA-000069-PIP02-10-M08
• Pharmaceutical form(s):
  • Solution for injection
  • Powder for solution for injection or infusion
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2017
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000069-PIP02-10-M08
• Compliance opinion date:
  10/11/2017
• Compliance outcome:
  Positive

Decision

P/0239/2017: EMA decision of 11 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab (Nucala), (EMEA-000069-PIP02-10-M08)

Adopted Reference Number: EMA/491414/2017