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海正藥業(600267.SH):子公司獲得甲潑尼龍片補充申請批件
格隆匯 11-28 17:52

格隆匯11月28日丨海正藥業(600267.SH)公佈,全資子公司瀚暉製藥有限公司收到國家藥品監督管理局核准簽發的關於甲潑尼龍片的《藥品補充申請批准通知書》。商標名:美卓樂®。根據《中華人民共和國藥品管理法》及有關規定,經審查,本品此次申請事項符合藥品註冊的有關要求,批准Pfizer Italia s.r.l公司將進口藥品甲潑尼龍片(規格4mg)生產技術轉讓至瀚暉製藥有限公司,發給藥品批准文號,質量標準、生產工藝照所附執行,有效期為24個月。

美卓樂®為國內上市的原研藥品,適用於治療非內分泌失調症:風濕性疾病、膠原疾病、皮膚疾病、過敏性疾病、眼部疾病、呼吸道疾病、血液病、腫瘤、水腫、胃腸道疾病、神經系統、器官移植等及內分泌失調疾病。

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