EMEA-001415-PIP02-21 - paediatric investigation plan

Vibegron

Key facts

• Active Substance:
  Vibegron
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0288/2022
• PIP number:
  EMEA-001415-PIP02-21
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of myoneurogenic bladder disorders
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Pierre Fabre Médicament

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  11/08/2022

Decision

P/0288/2022 : EMA decision of 11 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vibegron (EMEA-001415-PIP02-21)

AdoptedReference Number: EMA/629508/2022