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Home Industry News Sanofi aventis announces Ketek summary update

Sanofi aventis announces Ketek summary update

2nd April 2007

Pharmaceutical company sanofi-aventis has announced that following involvement from the European Medicines Agency (EMEA) Committee for Medicial Products for Human use (CHMP) it has revised the European Summary of Product Characteristics (SmPC) for Ketek.

The changes reflect the fact that while Ketek has been approved in Europe for use as a treatment for mild to moderate community acquired pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB), acute sinusitis (AS) and tonsillitis, it should only be prescribed for some of these illnesses when beta-lactams or macrolides are not appropriate.

Ketek is currently marketed in more than 50 countries worldwide, with sanofi-aventis estimating that more than 30 million courses of the medication have been prescribed across these nations.

A warning that was already in effect over the use of Ketek as a treatment for autoimmune disease myasthenia gravis has been upgraded, the company has reported. It is now classed as a contraindication.

Sanofi-aventis has also revealed that following the CHMP analysis, the SmPC has been changed to add a section regarding a strengthened warning about “temporary visual disturbances” as well as transient loss of consciousness associated with the medication.

The firm has a 5.3 per cent market share worldwide, with in the region of 100,000 employees.

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