Irish Medical News


Taxotere in one vial recommended for approval in European Union

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Sanofi-aventis recently an­nounced that the Co­mmittee for Medicinal Products for Human use (CHMP) of the European Medicine Agency (EMEA) has adopted a positive opinion recommending to grant a marketing authorisation in the European Union for the presentation in one vial of the anticancer medicine Taxotere (docetaxel).

This new one-vial-Taxotere consists of a single vial of docetaxel concentrate at 20mg/ml concentration, and like original Taxotere (Taxotere concentrate vial + diluents’ vial), it keeps a formulation with the same excipients, said Sanofi-aventis.


“One-vial-Taxotere is expected to simplify preparation by no longer requiring the initial dilution step that was necessary with the current two-vial presentation,” said Dr Anil Jina, medical director of sanofi-aventis Ireland, “offering greater convenience with an easier and quicker preparation.”

Taxotere is approved for use in treating patients at specific stages of five types of cancer: breast, non-small cell lung, prostate, gastric and head and neck cancer.  Since the drug was approved, Taxotere has been used worldwide to treat more than 1.5 million patients, of whom 100,000 were participants in clinical trials.


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