European Union approved Duodart for the treatment of prostatic hyperplasia

The EU has approved for use a combined product for the treatment of benign prostatic hyperplasia - a medicine called Duodart by the British company GlaxoSmithKline.

The application for the drug was approved in Germany through a decentralized procedure for obtaining marketing permission (Germany is the reference member state).

Getting a marketing license for the drug in other EU countries is expected during the current year with the launch on the pharmaceutical market in the next few months.

Duodart is a combination of the drug Avodart ® (dutasterid, GlaxoSmithKline) with tamsulosin that is marketed by Astellas Pharma Inc. under the brand name Flomax. It is approved for treatment of moderate-to-severe benign prostatic hyperplasia, as well as to reduce the risk of acute urinary retention in this group of patients.