EMEA-000597-PIP02-10-M10 - paediatric investigation plan

Mirabegron

Key facts

• Invented name:
  Betmiga
• Active substance:
  Mirabegron
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0502/2023
• PIP number:
  EMEA-000597-PIP02-10-M10
• Pharmaceutical form(s):
  • Polonged-release granules for oral suspension
  • Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of idiopathic overactive bladder
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2023
• Compliance check done:
  No

Decision

P/0502/2023: EMA decision of 1 December 2023 on the refusal of a modification of an agreed paediatric investigation plan and on the granting of a waiver for mirabegron (Betmiga), (EMEA-000597-PIP02-10-M10)

Adopted Reference Number: EMA/528354/2023