華邦健康(002004.SZ):阿伐斯汀膠囊通過一致性評價
格隆匯 9 月 7日丨華邦健康(002004.SZ)公佈,公司全資子公司重慶華邦製藥有限公司(“華邦製藥”)於近日收到國家藥品監督管理局核准簽發的關於阿伐斯汀膠囊的《藥品補充申請批准通知書》,該藥品正式通過國家仿製藥質量和療效一致性評價。
藥品名稱:阿伐斯汀膠囊;劑型:膠囊劑;規格:8mg;註冊分類:化學藥品;申請人:重慶華邦製藥有限公司;受理號:CYHB1950749;通知書編號:2020B04491;審批結論:經審查,該品通過仿製藥質量和療效一致性評價。
阿伐斯汀膠囊為強效競爭性組胺 H1受體拮抗劑,適用於緩解過敏性鼻炎,包括枯草熱的疾病症狀,也適用於慢性自發性蕁麻疹、皮膚劃痕症、膽鹼能性蕁麻疹和特發性獲得性寒冷性蕁麻疹。該藥品屬於第二代抗組胺藥物,與第一代抗組胺藥物相比,第二代抗組胺藥物具有親脂性低、鎮靜作用小、幾乎無抗膽鹼作用等優點,在臨牀上得到廣泛應用。
根據《國務院辦公廳關於開展仿製藥質量和療效一致性評價的意見》(國辦發[2016]8號)的規定,對於通過仿製藥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。此次公司全資子公司華邦製藥的藥品阿伐斯汀膠囊通過一致性評價,將增加公司產品市場競爭機會,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。
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