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Re: vinmantoo post# 11836

Saturday, 06/21/2008 2:07:57 AM

Saturday, June 21, 2008 2:07:57 AM

Post# of 19309
vin, I was basing my post about Genzyme Europe B.V. requesting the re-examination on the folling information.

The Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, refusing to allow the marketing authorization for ATryn 1750 IU powder for solution for infusion, to be used in surgical patients with congenital antithrombin deficiency for the prophylaxis of deep vein thrombosis and thromboembolism in clinical risk situations, i.e., during the peri-surgical period. Genzyme Europe B.V. may request a re-examination of the opinion.

http://patentbaristas.com/archives/cat_biotech_news.php

Then in this EMEA document it said that the company who applied in June 2006 that resulted in the approval was Genzyme Europe B.V.

http://www.emea.europa.eu/pdfs/general/direct/pr/19186206en.pdf

So does that mean Genzyme participated or was the lead in requesting an re-examination? What do you think?


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