EMEA-000997-PIP01-10-M06 - paediatric investigation plan

Selexipag

Key facts

• Invented name:
  Uptravi
• Active Substance:
  Selexipag
• Therapeutic area:
  Other
• Decision number:
  P/0088/2023
• PIP number:
  EMEA-000997-PIP01-10-M06
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of pulmonary arterial hypertension
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Janssen Cilag International NV

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/03/2023

Decision

P/0088/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for selexipag (Uptravi), (EMEA-000997-PIP01-10-M06)