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Drug

Darifenacin hydrobromide

Approved · EMA

Also known as Enablex.

RxNorm485417
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Emselex (EMA)

Regulatory2004-10-22EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Darifenacin hydrobromide
Aliases & brands
Enablex
RxNorm CUI
485417
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2004-10-22
Latest approval
2004-10-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2004-10-22Approval
Approval: Emselex (EMA)

Indication: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Regulatory event sources are credited in the Regulatory Timeline above.