EMA/PE/0000182297 - paediatric investigation plan

oxybutynin

Key facts

• Active substance:
  oxybutynin
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMA/PE/0000182297
• PIP number:
  EMA/PE/0000182297
• Pharmaceutical form(s):
  Vaginal delivery system
• Condition(s) / indication(s):
  Treatment of myoneurogenic bladder disorders
• Route(s) of administration:
  Vaginal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000182297: EMA decision of 6 December 2024 on the granting of a product specific waiver for oxybutynin

Adopted Reference Number: EMADOC-1700519818-1790205