European Commission clears Sanofi MSD/Merck & Co's Zostavax in European Union
The European Commission has granted a marketing authorization for Zostavax, an injection indicated for prevention of herpes zoster and herpes zoster-related post-herpetic neuralgia in individuals aged 60 years or older, making it the first and only vaccine registered in Europe for these conditions.
The agent was developed by US drug major Merck & Co and Sanofi Pasteur MSD, a joint venture that it set up with Sanofi Pasteur, the vaccines division of French pharmceutical major and world number three Sanofi-Aventis, and will be marketed in Europe by the JV.
Sanofi Pasteur MSD noted that the licences granted as part of the EC's decision are for a frozen formulation of the vaccine but the firm will file a variation with the European Medincines Agency (EMEA) for the refrigerated formulation as soon as the final analysis of the relevant scientific data has been completed.
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