EMA/PE/0000221175 - paediatric investigation plan

vibegron

Key facts

• Invented name:
  Obgemsa
• Active substance:
  vibegron
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMA/PE/0000221175
• PIP number:
  EMA/PE/0000221175
• Pharmaceutical form(s):
  • Film-coated tablet
  • Granules
• Condition(s) / indication(s):
  Treatment of myoneurogenic bladder disorders
• 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:
  16/12/2024
• Compliance check done:
  Nej

Decision

EMA/PE/0000221175 : EMA decision of 16 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for vibegron

Adopted Reference Number: EMADOC-1700519818-1807888