12.11.2014 13:48:05
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Alimera Announces Marketing Authorization For ILUVIEN In Brazil - Quick Facts
(RTTNews) - Alimera Sciences, Inc. (ALIM), a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, said the Belgian Federal Agency for Medicines and Health Products or FAMHP has granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema or DME considered insufficiently responsive to available therapies.
Approval in Belgium marks the fourth European approval through the Repeat-Use application procedure. This was also and the 12th approval worldwide, including the recent U.S. approval for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
To date, ILUVIEN is now approved for marketing in Austria, Belgium, Denmark, France, Germany, Italy, Norway, Portugal, Spain, Sweden, the United Kingdom and the United States, and is commercially available in the United Kingdom and Germany.
ILUVIEN is pending approval in an additional six European Union countries included in the Repeat-Use application procedure. These countries are the Czech Republic, Finland, Ireland, Luxembourg, the Netherlands and Poland.
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