Betmiga (mirabegron)
- Region
- 🇪🇺 EU
- Active substance
- mirabegron
- Company
- Astellas Pharma Europe B.V.
- Status
- Authorised
- Therapeutic area
- Urinary Bladder, Overactive
- CHMP opinion
- Thu 18 Oct 2012
- EU approval
- Thu 20 Dec 2012
- Application
- EMEA/H/C/002388
- ATC
- G04BD12
- Official record
- www.ema.europa.eu
Indication
Overactive bladder in adults Betmiga prolonged-release tablets are indicated for symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. Neurogenic detrusor overactivity in the paediatric population Betmiga prolonged release tablets are indicated for treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 3 to less than 18 years.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.