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華海藥業(600521.SH):獲得“奧氮平口崩片”藥品註冊批件
格隆匯 07-03 16:35

格隆匯 7 月 3日丨華海藥業(600521.SH)公佈,近日收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的《藥品註冊批件》,現將相關情況公告如下:

一、藥品的基本情況

藥品名稱:奧氮平口崩片

劑型:片劑

規格:2.5mg、5mg

申請事項:國產藥品註冊

註冊分類:化學藥品4類

申報階段:生產

申請人:浙江華海藥業股份有限公司

藥品批准文號:國藥準字H20203281、國藥準字H20203282

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准註冊,發給藥品批准文號。

二、藥品其他相關情況

2018年12月,公司向國家藥品監督管理局藥品審評中心遞交的藥品註冊申請獲得受理;近日,公司收到國家藥監局核准並簽發的奧氮平口崩片《藥品註冊批件》。

奧氮平口崩片主要用於治療精神分裂症、中到重度躁狂發作,還可以用於預防雙向情感障礙的復發。奧氮平口崩片由禮來公司研發,最早於2002年2月在歐洲獲批上市。奧氮平口崩片全球主要生產廠商有邁蘭公司、阿拉賓度製藥等,國內生產廠商有江蘇豪森藥業集團有限公司、廣東東陽光藥業有限公司等。據統計,2019年奧氮平製劑產品(包括所有制劑劑型)全球市場銷售額約13.765億美元(數據來源於PDB數據庫);2019年國內奧氮平片劑產品(包括片劑和口崩片)全國等級醫院銷售額約人民幣18.28億元(數據來源於鹹達數據庫)。

截至目前,公司在奧氮平口崩片研發項目上已投入研發費用約人民幣937萬元。

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