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July 25, 2014
07:33 EDTAGNEMA recommends expanded indication for Ozurdex
The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Ozurdex from Allergan Pharmaceuticals Ireland. The CHMP adopted a new indication as follows: "Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular edema who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy."
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