復星醫藥(600196.SH):控股子公司獲藥品註冊申請受理
格隆匯11月4日丨復星醫藥(600196.SH)公佈,公司控股子公司重慶藥友製藥有限責任公司的左氧氟沙星注射液(以下簡稱“新藥1”)、控股子公司吉斯美(武漢)製藥有限公司的阿糖胞苷注射液(以下簡稱“新藥2”)的藥品註冊申請分別獲國家藥品監督管理局受理。
新藥1、新藥2均為本集團(即本公司及控股子公司/單位,下同)自主研發的化學藥品。
新藥1擬用於敏感細菌所引起的下列輕、中、重度感染:(1)醫院獲得性肺炎;(2)社區獲得性肺炎;(3)急性細菌性鼻竇炎;(4)慢性支氣管炎的急性細菌性發作;(5)複雜性皮膚及皮膚結構感染;(6)非複雜性皮膚及皮膚軟組織感染;(7)慢性細菌性前列腺炎;(8)複雜性尿路感染;(9)急性腎盂腎炎;(10)單純性尿路感染;(11)吸入性炭疽(暴露後)。
新藥2擬用於(1)與其他細胞抑制劑聯合治療成人和兒童急性髓性白血病,誘導和維持緩解;(2)治療急性淋巴細胞白血病、慢性骨髓性白血病淋巴細胞增生危象和紅細胞增多症;(3)與其他細胞毒性藥物聯合用於兒童非霍奇金淋巴瘤,可單獨使用,也可與其他細胞抑制劑聯合使用;(4)急性白血病的大劑量治療;(5)單獨或聯合使用氫化可的松琥珀酸鈉和甲氨蝶呤對腦膜腦炎進行鞘內預防和治療。
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