EMEA-003002-PIP03-22 - paediatric investigation plan

derivative of 6-[2-(pyridin-2-yl)phenoxy]methyl}-1,2,3,4-tetrahydroisoquinoline

Key facts

• Active substance:
  derivative of 6-[2-(pyridin-2-yl)phenoxy]methyl}-1,2,3,4-tetrahydroisoquinoline
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0387/2023
• PIP number:
  EMEA-003002-PIP03-22
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of portal hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  07/09/2023
• Compliance check done:
  No

Decision

P/0387/2023 ; EMA decision of 7 September 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for derivative of 6-[2-(pyridin-2-yl)phenoxy]methyl}-1,2,3,4-tetrahydroisoquinoline, (EMEA

Reference Number: EMA/388403/2023