EMEA-003531-PIP01-23 - paediatric investigation plan

(R)-3-(1-cyclopropyl-3-(2-fluoro-4-(trifluoromethoxy)benzyl)ureido)piperidine-1-carboxamide (JNT-517)

Key facts

• Active substance:
  (R)-3-(1-cyclopropyl-3-(2-fluoro-4-(trifluoromethoxy)benzyl)ureido)piperidine-1-carboxamide (JNT-517)
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0357/2024
• PIP number:
  EMEA-003531-PIP01-23
• Pharmaceutical form(s):
  • Oral powder
  • Tablet
  • Granules for oral suspension
• Condition(s) / indication(s):
  Treatment of hyperphenylalaninemia
• 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:
  25/10/2024
• Compliance check done:
  No

Decision

P/0357/2024 : EMA decision of 25 October 2024 on agreement of a paediatric investigation plan and on granting of a deferral for (R)-3-(1-cyclopropyl-3-(2-fluoro-4-(trifluoromethoxy)benzyl)ureido)piperidine-1-carboxamide (JNT-517) (EMEA-003531-PIP01-23)

Adopted Reference Number: EMA/443765/2024