EMEA-000597-PIP03-15-M05 - paediatric investigation plan

Mirabegron

Key facts

• Invented name:
  • Betmiga
  • Betmiga
• Active Substance:
  Mirabegron
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0187/2022
• PIP number:
  EMEA-000597-PIP03-15-M05
• 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
• 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:
  25/05/2022

Decision

P/0187/2022 : EMA decision on 25 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga), (EMEA-000597-PIP03-15-M05)

AdoptedReference Number: EMA/274001/2022