News from Zentiva


October 26, 2021    /    2021

Zent2U will be the first offering EU dossier for Finasteride / Tadalafil 5 mg / 5 mg fixed-dose combination

Zent2U is glad to announce that it is in the final stage of the development of the fixed dose combination Finateride / Tadalafil 5 mg / 5 mg. 

Finasteride (brand name Proscar®) (5 alpha-reductase inhibitor) is approved to treat symptoms of BPH, reduce the risk of acute urinary retention and decrease the potential need for prostate surgery. Tadalafil 5mg (brand name Cialis ®) is approved to treat both BPH and erectile dysfunction. 

Finasteride alone is  targeting a reduction of the prostate volume, as a treatment for BPH (Benign prostatic hyperplasia) / LUTS (lower urinary tract symptoms). A reduction of the volume of the gland starts in approximately 3-6 months, which may be a long time for symptomatic relief for patients. Also, frequent adverse reactions of Finasteride as well as other BPH treatments are impotence and decreased libido and nearly 50% of the patients report some degree of erectile dysfunction. The combination Finasteride / Tadalafil addresses slower symptomatic relief from finasteride alone, and other BPH treatment side effects like erectile dysfunction, and hence improving the quality of life of the patient. We are confident that the combination may increase patient adherence to treatment and recommended lifestyle changes.

The dossier will be available for submission in Europe in December 2021 assuring that Zent2U partners will be the first in the market with this value-added medicine.

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Tomas Pilarcik

Key Account Manager

Thomas Koene

Head of Growth Partnerships

Mihai Stoian

Key Account Manager

Clara Vitaller

Key Account Manager



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