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京新藥業(002020.SZ):鹽酸普拉克索緩釋片獲得藥品註冊批件
格隆匯 07-29 17:52

格隆匯 7 月 29日丨京新藥業(002020.SZ)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的化學藥品“鹽酸普拉克索緩釋片”【規格0.375mg0.75mg】的《藥品註冊證書為國內首家獲批廠家,並視同通過一致性評價批准文號分別為國藥準字H20203341H20203342批准文號有效期至20250720日。

鹽酸普拉克索緩釋片德國勃林格殷格翰藥業有限公司開發研製的用於治療特發性帕金森病的體徵和症狀,即在整個疾病過程中,包括疾病後期,當左旋多巴的療效逐漸減弱或者出現變化和波動(劑末現象或“開關”波動)時,都可以單獨應用本品(無左旋多巴)或與左旋多巴聯用。

鹽酸普拉克索緩釋片通過緩釋技術使藥物緩慢釋放,每天僅需一次用藥,可更好地滿足國內患者需求,增加患者依從性,減少患者就醫費用,降低醫療成本,帶來良好的社會價值和經濟效益。

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