EMEA-000597-PIP02-10-M09 - paediatric investigation plan

Mirabegron

Key facts

• Invented name:
  Betmiga
• Active Substance:
  Mirabegron
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0550/2022
• PIP number:
  EMEA-000597-PIP02-10-M09
• 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
• Contact for public enquiries:

  Astellas Pharma Europe B.V.

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/01/2023

Decision

P/0550/2022 : EMA decision of 4 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga), (EMEA-000597-PIP02-10-M09)

Reference Number: EMA/678/2023