EMEA-003098-PIP01-21 - paediatric investigation plan

(1R,2R)-2-[4-(5-methyl-1H-pyrazol-3-yl) benzoyl]-N-(4-oxo-6,7-dihydro-5H-pyrazolo [1,5-a]pyrazin-3-yl)cyclohexanecarboxamide (AZD5718)

Key facts

• Active Substance:
  (1R,2R)-2-[4-(5-methyl-1H-pyrazol-3-yl) benzoyl]-N-(4-oxo-6,7-dihydro-5H-pyrazolo [1,5-a]pyrazin-3-yl)cyclohexanecarboxamide (AZD5718)
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0269/2022
• PIP number:
  EMEA-003098-PIP01-21
• Pharmaceutical form(s):
  • Age appropriate oral solid pharmaceutical form
  • Film-coated tablet
• Condition(s) / indication(s):
  Proteinuric chronic kidney disease
• 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:
  11/08/2023

Decision

P/0269/2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (1R,2R)-2-[4-(5-methyl-1H-pyrazol-3-yl) benzoyl]-N-(4-oxo-6,7-dihydro-5Hpyrazolo...(EMEA-003098-PIP01-21)

Reference Number: EMA/662865/2022