EMEA-002754-PIP01-19 - paediatric investigation plan

allopurinol

verinurad

Key facts

• Active substance:
  • allopurinol
  • verinurad
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0017/2021
• PIP number:
  EMEA-002754-PIP01-19
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of 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:
  29/01/2021
• Compliance check done:
  Όχι

Decision

P/0017/2021 : EMA decision of 29 January 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for verinurad / allopurinol (EMEA-002754-PIP01-19)

Adopted Reference Number: EMA/33649/2021