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上海醫藥(601607.SH):鹽酸胺碘酮片通過仿製藥一致性評價
格隆匯 10-23 16:50

格隆匯 10 月 23日丨上海醫藥(601607.SH)公佈,近日,公司控股子公山東信誼制藥有限公司(“山東信誼”)收到國家藥品監督管理局頒發的關於鹽酸胺碘酮的《藥品補充申批准通知書(通知書編號:2020B04726),該藥品通過仿製藥一致性評價。

鹽酸胺碘酮片抗心絞痛藥,主要適用於房性、結性、室性和伴W-P-W綜合徵的心律失常,由WYETH PHARMS研發,最早於1985在美國上市。201912月,山東信誼就該藥品仿製藥一致性評價向國家藥監局提出申請並獲受理。截至公告日,公司針對該藥品的一致性評價已投入研發費用約人民幣892萬元。

截至公告日,中國境內該藥品的主要生產廠家賽諾菲(杭州)製藥有限公司海上藥信誼藥廠有限公司寧波大紅鷹藥業股份有限公司

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