EMEA-001032-PIP03-19 - paediatric investigation plan

Macitentan

Key facts

• Invented name:
  Opsumit
• Active Substance:
  Macitentan
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0242/2021
• PIP number:
  EMEA-001032-PIP03-19
• Pharmaceutical form(s):
  • Film-coated tablet
  • Dispersible tablet
• Condition(s) / indication(s):
  Treatment of functional single ventricle heart disease with total cavo-pulmonary connection
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  09/07/2021

Decision

P/0242/2021: EMA decision of 7 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for macitentan (Opsumit) (EMEA-001032-PIP03-19)

Reference Number: EMA/315432/2021