Cimex wins German approval for Clopidogrel

The market launch in Germany is delayed preliminarily because the originator firm Sanofi-Aventis has challenged the approval as has been expected. For the time being, this prevents the approval from being executed.

However, in the case the approval is executed by the Federal Institute for Drugs and Medical Devices (BfArM) or by an administrative court, which is possible anytime, the marketing of clopidogrel can start immediately.

In cooperation with their marketing partners, Cimex and its holding company Schweizerhall have also taken legal action, including requesting accelerated court proceedings, to achieve immediate execution of the approval. A court decision is expected within a few months. The applications for approval in other countries are not affected by the current issue in Germany.