EMEA-000597-PIP03-15-M06 - paediatric investigation plan
Mirabegron
PIPHuman
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
- Contact for public enquiries
Astellas Pharma Europe B.V.
Tel. +31 7154 55878
E-mail: contact.nl@astellas.com- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date