Emselex (darifenacin hydrobromide)
- Region
- 🇪🇺 EU
- Active substance
- darifenacin hydrobromide
- Company
- pharmaand GmbH
- Status
- Authorised
- Therapeutic area
- Urinary Incontinence, Urge; Urinary Bladder, Overactive
- CHMP opinion
- Thu 29 Jul 2004
- EU approval
- Fri 22 Oct 2004
- Application
- EMEA/H/C/000554
- ATC
- G04BD10
- Official record
- www.ema.europa.eu
Indication
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
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.