EMEA-000434-PIP01-08-M10 - paediatric investigation plan

ambrisentan

Key facts

• Invented name:
  Volibris
• Active substance:
  ambrisentan
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0384/2024
• PIP number:
  EMEA-000434-PIP01-08-M10
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of pulmonary arterial hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

P/0384/2024: EMA decision of 25 October 2024 on the refusal of a modification of an agreed paediatric investigation plan for ambrisentan (Volibris), (EMEA-000434-PIP01-08-M10)

Adopted Reference Number: EMA/485479/2024