哈三聯(002900.SZ):米氮平片(30mg)首家通過一致性評價
格隆匯1月20日丨哈三聯(002900.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的關於米氮平片(30mg)的《藥品補充申請批件》。
2020年1月15日,公司米氮平片(30mg)國內首家通過一致性評價並獲得藥品註冊批件。截至目前,公司米氮平片(15mg及30mg)均為國內首家通過一致性評價。
米氮平片主要用於抑鬱症的治療。原研公司為荷蘭Organon(歐加農製藥),最早於1994年在荷蘭批准上市,2004年在國內進口批准上市,其屬於國家醫保目錄甲類品種(2019年版)和基本藥物目錄品種(2018年版)。
根據國家相關政策,通過一致性評價的藥品品種,在醫保支付方面予以適當支持,醫療機構應優先採購併在臨牀中優先選用,同品種藥品通過一致性評價的生產企業達到3家以上的,在藥品集中採購等方面不再選用未通過一致性評價的品種,未超過3家的,優先採購和使用已通過一致性評價的品種。因此公司米氮平片(30mg)通過一致性評價,有利於擴大產品的市場銷售,提高市場競爭力,對公司的經營業績產生積極影響,併為後續產品開展仿製藥一致性評價積累了寶貴的經驗。
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