EMEA-003204-PIP01-22 - paediatric investigation plan

Treprostinil (palmitil)

Key facts

• Active Substance:
  Treprostinil (palmitil)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0525/2022
• PIP number:
  EMEA-003204-PIP01-22
• Pharmaceutical form(s):
  Inhalation powder
• Condition(s) / indication(s):
  Treatment of pulmonary hypertension due to lung disease and/or hypoxia
• Route(s) of administration:
  Inhalation use
• Contact for public enquiries:

  Insmed Netherlands B.V.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/12/2022

Decision

P/0525/2022 : EMA decision of 30 December 2022 on the granting of a product specific waiver for treprostinil (palmitil) (EMEA-003204-PIP01-22)

Reference Number: EMA/929791/2022