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長春高新(000661.SZ):華康藥業成為強力枇杷露的藥品上市許可持有人
格隆匯 09-10 15:58

格隆匯9月10日丨長春高新(000661.SZ)公佈,公司收到控股子公吉林華康藥業股份有限公司(“華康藥業”)的通知,華康藥業於近日收到國家藥品監督管理局核准簽發的強力枇杷露《藥品補充申請批准通知書》,同意華康藥業作為上述藥品上市許可持有人。

藥品申請事項:強力枇杷露的上市許可持有人由“威海人生藥業有限公司”變更為“吉林華康藥業股份有限公司”,生產企業及生產地址不變。

審批結論主要內容:經審查,本品此次申請事項符合藥品註冊的有關要求, 意按照《藥品上市後變更管理辦法(試行)》相關規定,批准本品上市許可持有人由威海人生藥業有限公司(地址:山東省威海市環翠區張村鎮雍江街20)”變更為“吉林華康藥業股份有限公司(地址:吉林省敦化市華康大街10號)”,藥品批准文號不變。

公司控股子公司華康藥業成為上述藥品上市許可持有人,對公司近期經營業績不會產生重大影響。公司積極儲備具有發展潛力的藥品品種,進一步豐富公司產品線, 有利於公司的可持續發展。

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