EMEA-001032-PIP01-10-M07 - paediatric investigation plan

macitentan

Key facts

• Invented name:
  Opsumit
• Active substance:
  macitentan
• Therapeutic area:
  Cardiac disorders
• Decision number:
  P/0457/2023
• PIP number:
  EMEA-001032-PIP01-10-M07
• Pharmaceutical form(s):
  • Dispersible tablet
  • Film-coated tablet
• Condition(s) / indication(s):
  • Treatment of idiopathic pulmonary fibrosis
  • Treatment of pulmonary arterial hypertension
  • Treatment of systemic sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-001032-PIP01-10-M07
• Compliance opinion date:
  23/02/2024
• Compliance outcome:
  Positive

Decision

P/0457/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for macitentan (Opsumit), (EMEA-001032-PIP01-10-M07)

Adopted Reference Number: EMA/517330/2023