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溴芬酸鈉滴眼液

Bromfenac Sodium Hydrate Ophthalmic Solution

最有效的環氧合酶抑制劑,消炎鎮痛作用是其它非甾體抗炎藥的10

中文名:  芬酸鈉滴眼液

英文名:  Bromfenac Sodium Hydrate Ophthalmic Solution

商品名 普羅納克

本品主要成份芬酸鈉水合物,其化學名為:2-氨基 -3-(4- 溴苯甲?;?/span>)苯乙酸鈉

劑型規格滴眼劑,0.1%5ml5mg 

適應癥于外眼部和前眼部的炎癥性疾病的對癥療法,結膜炎,鞏膜炎,術后炎癥。

開發階段  

溴芬酸鈉滴眼液最早由日本Senju公司(千壽制藥株式會社)開發,于2000年在日本上市,商品名ロナック®點眼液( BRONUCK®OPHTHALMIC SOL UTION),用于外眼部及前眼部炎癥性疾病,如眼瞼類、結膜類、強膜類(包括上強膜炎)、術后炎癥等地對癥治療。在美國已完成治療白內障術后眼部發炎、疼痛及畏光癥狀的期臨床研究,并于2004年第二季度向FDA提出新藥申請,20053月在美國以商品名XibromTM上市, 用于治療白內障術后眼部發炎、疼痛及畏光癥狀。我國已于2009年批準進口,進口注冊證號為H20090843,商品名為普羅納克(BRONUCK)。

開發進度已完成補充資料的回復,即將批準。

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