EMEA-003165-PIP01-21 - paediatric investigation plan

Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one

Key facts

• Active Substance:
  Derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0474/2022
• PIP number:
  EMEA-003165-PIP01-21
• Pharmaceutical form(s):
  • Age-appropriate oral (liquid or solid) dosage form
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of chronic kidney disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Boehringer Ingelheim International GmbH

  Tel. [phone]; Email: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/12/2022

Decision

P/0474/2022: EMA decision of 1 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for derivative of 3‐phenyl‐3H,4H,6H,7H‐pyrano[3,4‐d]imidazol‐4‐one (EMEA-003165-PIP01-21)

AdoptedReference Number: EMA/897998/2022