EMEA-003182-PIP01-22-M01 - paediatric investigation plan

Treprostinil sodium

Key facts

• Invented name:
  Trisuva and associated names
• Active Substance:
  Treprostinil sodium
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0500/2023
• PIP number:
  EMEA-003182-PIP01-22-M01
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of pulmonary arterial hypertension
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/12/2023

Decision

P/0500/2023: EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for treprostinil (sodium) (Trisuva and associated names), (EMEA-003182-PIP01-22-M01)

AdoptedReference Number: EMA/515863/2023