EMEA-000597-PIP03-15-M06 - paediatric investigation plan

Mirabegron

Key facts

• Invented name:
  • Betmiga
  • Betmiga
• Active substance:
  Mirabegron
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0085/2024
• PIP number:
  EMEA-000597-PIP03-15-M06
• Pharmaceutical form(s):
  • Prolonged-release granules for oral suspension
  • Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of neurogenic detrusor overactivity
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/03/2024
• Compliance check done:
  Ne

Decision

P/0085/2024: EMA decision of the 15 of March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga) (EMEA-000597-PIP03-15-M06)

Adopted Reference Number: EMA/104845/2024