EMEA-001032-PIP02-17 - paediatric investigation plan

macitentan

Key facts

• Invented name:
  • Opsumit
  • Opsumit
• Active substance:
  macitentan
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0215/2017
• PIP number:
  EMEA-001032-PIP02-17
• Pharmaceutical form(s):
  • Dispersible tablet
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of chronic thromboembolic pulmonary hypertension (CTEPH)
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/08/2017
• Compliance check done:
  Non

Decision

P/0215/2017: EMA decision of 9 August 2017 on the granting of a product-specific waiver for macitentan (Opsumit), (EMEA-001032-PIP02-17)

Adopted Reference Number: EMA/459094/2017