立方製藥(003020.SZ):控股子公司收到藥品註冊受理通知書
格隆匯3月19日丨立方製藥(003020.SZ)公佈,近日,公司控股子公司合肥諾瑞特製藥有限公司收到國家藥品監督管理局下發的加替沙星滴眼液藥品註冊上市許可申請的《受理通知書》。申請事項:境內生產藥品註冊上市許可
產品名稱:加替沙星滴眼液
規 格:0.3%(5ml:15mg)
受理說明:根據《中華人民共和國行政許可法》第三十二條的規定,經審查,
決定予以受理。
受理號:CYHS2501***
加替沙星是一種環丙基氟喹諾酮類藥物,爲第四代喹諾酮類廣譜抗菌藥物,主要用於由敏感病原體所致的各種感染性疾病。加替沙星滴眼液用於眼瞼炎、淚囊炎、麥粒腫、結膜炎、瞼板腺炎、角膜炎(包括角膜潰瘍)、眼科圍手術期的無菌化治療。本次申報是以日本千壽製藥株式會社的未進口原研藥品爲參比製劑進行開發研究,爲仿製境外上市但境內未上市原研藥品的藥品(註冊分類爲化藥3類)。
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