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海辰藥業:苯磺酸氨氯地平片通過仿製藥一致性評價
格隆匯 02-10 16:27

格隆匯2月10日丨海辰藥業(300584.SZ)公佈,近日,公司收到國家藥品監督管理局核准簽發的公司產品苯磺酸氨氯地平片的《藥品補充申請批件》,該產品通過仿製藥質量和療效一致性評價。

藥品名稱:苯磺酸氨氯地平片;劑型:片劑;規格:5mg(按C20H25ClN2O5計);註冊分類:化學藥品;生產企業:南京海辰藥業股份有限公司;批件號:2020B02173;原藥品批准文號:國藥準字H20093727;申請內容:仿製藥質量和療效一致性評價;審批結論:經審查,本品通過仿製藥質量和療效一致性評價。

2018年11月30日,公司向國家藥監局遞交的本品仿製藥一致性評價申請獲受理。苯磺酸氨氯地平片的適應症為:高血壓、冠心病、心絞痛,是全球處方量最大的心血管藥物之一。苯磺酸氨氯地平片的原研廠家為輝瑞製藥有限公司(Pfizer Inc.),商品名“絡活喜”(NORVASC®)。

公司苯磺酸氨氯地平片通過仿製藥一致性評價,有利於提升該藥品的市場競爭力,同時為公司其他產品開展仿製藥一致性評價工作積累了經驗,公司將以此為契機,進一步加快其他產品的一致性評價工作。

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