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Rosuvastatin + Ezetimibe + ASA

Benefits at a glance

  • Lifecycle management for Rosuvastatin + Ezetimibe combination
  • High perecentage of the Rosuvastatin + Ezetemibe patients are already treated with Acetylsalicylic acid (ASA) (baseline treatment).

Product details

Indication

Substitution indication for treatment of Dyslipidemia.

Strengths

5mg + 10mg + 100mg
10mg + 10mg + 100mg
20mg + 10mg + 100mg
40mg + 10mg + 100mg

Dosage form

Capsule

API

Rosuvastatin + Ezetimibe + ASA

Regulatory approach

New fixed-dose combination
Substitution of both mono substances

Dossier available

Q2/2026

Turnover

n.a.

Development by

Midas Pharma

Status

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

Summary

With our new fixed dose combination, we have combined three established active ingredients used for the treatment of Dyslipidemia.

Our triple combination of Rosuvastatin + Ezetimibe + ASA is a logical lifecycle addition to the already existing combination of Rosuvastatin + Ezetimibe.

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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