科倫藥業(002422.SZ):鹽酸達泊西汀片獲藥品註冊批件
格隆匯5月8日丨科倫藥業(002422.SZ)公佈,公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“鹽酸達泊西汀片”的《藥品註冊批件》。
藥品名稱:鹽酸達泊西汀片;劑型:片劑;規格:30mg;60mg(按C21H23NO計);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;受理號:CYHS1800029;CYHS1800030;藥品批准文號:國藥準字H20203189;國藥準字H20203190;審評結論: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。
鹽酸達泊西汀片為強生公司開發的選擇性5-羥色胺再攝取抑制劑(SSRIs),2008年在英國首獲批,後相繼在瑞典、德國、西班牙等多個歐洲國家獲批,2010年在中國獲批進口,用於治療18-64歲男性早泄患者。
早泄(PE)為男性最常見的性功能障礙,嚴重影響患者性生活質量,引起家庭不和諧,甚至導致心理疾病。達泊西汀為全球主流國家首個且唯一批准用於治療早泄的口服藥物,屬於短效SSRIs,具有可按需服用、起效迅速、療效確切等臨牀優勢,目前已被歐洲泌尿外科協會《男性性功能障礙指南(2019)》、《早泄中西醫結合診療指南(2018)》和《PE篩查與醫患溝通-PE診治中國專家共識(2016)》等國內外權威指南和專家共識推薦作為治療早泄的一線藥物。
公司鹽酸達泊西汀片為2015年國家藥監政策改革後,按照仿製藥必須與原研一致的要求研究、申報與獲批,質量和療效與原研(商品名:必利勁/Priligy,生產商:Menarini-Von Heyden GmbH)等同。
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