EMA/PE/0000244980 - paediatric investigation plan

mirabegron

solifenacin

Key facts

• Active substance:
  • mirabegron
  • solifenacin
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMA/PE/0000244980
• PIP number:
  EMA/PE/0000244980
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of neurogenic detrusor overactivity
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/06/2025
• Compliance check done:
  No

Decision

EMA/PE/0000244980 : EMA decision of 13 June 2025 on the granting of a product specific waiver for mirabegron / solifenacin

Adopted Reference Number: EMADOC-1700519818-2192782