EMEA-002310-PIP02-17 - paediatric investigation plan

(2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridin-2-yl)-4- fluoropyrrolidine-2-carboxamide (ACH-0144471)

Key facts

• Active substance:
  (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridin-2-yl)-4- fluoropyrrolidine-2-carboxamide (ACH-0144471)
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0243/2019
• PIP number:
  EMEA-002310-PIP02-17
• Pharmaceutical form(s):
  • Tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of C3 glomerulopathy
• 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:
  17/07/2019
• Compliance check done:
  No

Decision

P/0243/2019: EMA decision of 17 July 2019 on the agreement of a PIP and on the granting of a deferral and on the granting of a waiver for ACH-0144471 (EMEA-002310-PIP02-17)

Adopted Reference Number: EMA/364990/2019