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Tamsulosin + Tadalafil

Benefits at a glance

  • Tamsulosin is the gold standard in Lower Urinary Tract Symptoms (LUTS) treatment
  • Combination is supported by clinical data

Product details

Indication

Substitution indication for treatment of signs and symptoms of BPH in male patients already adequately controlled with Tamsulosin and Tadalafil.

Strengths

0.4mg + 5mg

Dosage form

Tablet

API

Tamsulosin + Tadalafil

Regulatory approach

New fixed-dose combination
Substitution of both mono substances

Dossier available

Q2/2025

Turnover

n.a.

Development by

Midas Pharma

Status

  • Development Kick-off
  • Formulation Development
  • Prototype
  • Pilot BE
  • Scale up ongoing
  • Pivotal BE
  • 6 M Stability
  • Dossier
  • EU-Approval

Summary

With our new fixed dose combination, we have combined two established active ingredients used for the treatment of signs and symptoms of BPH in male patients already adequately controlled with Tamsulosin and Tadalafil.

Since tamsulosin is the gold standard for the treatment of LUTS, our combination prevents the patients from negative side effects like erectile disfunction and completes the Midas urology portfolio.

It delivers the required medication while reducing the number of single tablets patients need to take. This improves patients compliance and quality of life in the long term.

Your Contact

Heike Sagi

Heike Sagi

Business Development & Licensing
Senior Director

Midas Pharma GmbH
Rheinstraße 49
55218 Ingelheim
Germany
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    The exploitation, including the development, sale and offer for sale of products and related processes is performed by Midas only in those territories where permissible by applicable patent law in particular, but not limited to EC Directive 2001/83 EC, Article 10, as amended by EC Directive 2004/27 EC. This document, therefore, does not and shall not constitute an offer for sale for the product in territories where an offer for sale or sale is not permissible by law. Midas expressly disclaims any liability for the information provided in this document as well as for damages resulting from or arising out of the use of the product and related process for purposes other than research and development in compliance with applicable laws.

     

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