EMEA-000207-PIP01-08-M08 - paediatric investigation plan

Treprostinil

Key facts

• Active Substance:
  Treprostinil
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0206/2023
• PIP number:
  EMEA-000207-PIP01-08-M08
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of pulmonary arterial hypertension
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Contact for public enquiries:

  Ferrer Internacional, S.A.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2023

Decision

P/0206/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for treprostinil (Remodulin) (EMEA-000207-PIP01-08-M08)

Reference Number: EMA/236607/2023