EMEA-002773-PIP01-20-M01 - paediatric investigation plan

(S)-2-(5-((3-ethoxypyridin-2-yl)oxy)pyridin-3-yl)-N-(tetrahydrofuran 3 yl) pyrimidine-5-carboxamide (PF-06865571)

Key facts

• Active substance:
  (S)-2-(5-((3-ethoxypyridin-2-yl)oxy)pyridin-3-yl)-N-(tetrahydrofuran 3 yl) pyrimidine-5-carboxamide (PF-06865571)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0326/2023
• PIP number:
  EMEA-002773-PIP01-20-M01
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of non-alcoholic steatohepatitis (NASH)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/08/2023
• Compliance check done:
  No

Decision

P/0326/2023 : EMA decision of 8 August 2023 on the acceptance of a modification of an agreed PIP for (S)-2-(5-((3- ethoxypyridin-2-yl)oxy)pyridin-3-yl)-N-(tetrahydrofuran 3 yl) pyrimidine-5-carboxamide (PF- 06865571), (EMEA-002773-PIP01-20-M01)

Reference Number: EMA/344544/2023