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news.Croma-Pharma has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) which has recommended a marketing authorization for Yellox, 1mg/ml, eye drops, solution to treat postoperative ocular inflammation.
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The active substance of Yellox is bromfenac, an anti-inflammatory agent, non-steroids, ATC code: S01BC11, with mechanism of action through blockage of the prostaglandin synthesis by inhibiting primarily cyclooxygenase 2 (COX-2).
CHMP said that the marketing authorization recommendation has been made on the basis of safety and efficacy data submitted by the company.
Croma-Pharma claims that Yellox is effective in the treatment of post-operative ocular inflammation in subjects undergoing cataract extraction with posterior intraocular chamber lens implantation.