🇪🇺 DARIFENACIN HYDROBROMIDE in European Union

EMA authorised DARIFENACIN HYDROBROMIDE on 22 October 2004

Marketing authorisation

EMA — authorised 22 October 2004

  • Application: EMEA/H/C/000554
  • Marketing authorisation holder: pharmaand GmbH
  • Local brand name: Emselex
  • Indication: Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
  • Status: approved

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DARIFENACIN HYDROBROMIDE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is DARIFENACIN HYDROBROMIDE approved in European Union?

Yes. EMA authorised it on 22 October 2004.

Who is the marketing authorisation holder for DARIFENACIN HYDROBROMIDE in European Union?

pharmaand GmbH holds the EU marketing authorisation.