EMEA-000997-PIP01-10-M07 - paediatric investigation plan

selexipag

Key facts

• Invented name:
  Uptravi
• Active substance:
  selexipag
• Therapeutic area:
  Other
• Decision number:
  P/0417/2023
• PIP number:
  EMEA-000997-PIP01-10-M07
• 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:
  25/10/2023
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000997-PIP01-10-M07
• Compliance opinion date:
  19/01/2024
• Compliance outcome:
  Positive

Decision

P/0417/2023 : EMA decision of 25 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for selexipag (Uptravi), (EMEA-000997-PIP01-10-M07)

Adopted Reference Number: EMA/469191/2023