EMEA-001202-PIP02-13-M04 - paediatric investigation plan

Reslizumab

Key facts

• Invented name:
  Cinqaero
• Active Substance:
  Reslizumab
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0305/2020
• PIP number:
  EMEA-001202-PIP02-13-M04
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• 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:
  12/08/2020

Decision

P/0305/2020 : EMA decision of 12 August 2020 on the acceptance of a modification of an agreed paediatric investigation plan for reslizumab (Cinqaero) (EMEA-001202-PIP02-13-M04)

AdoptedReference Number: EMA/413459/2020