北陸藥業(300016.SZ):釓噴酸葡胺注射液通過仿製藥一致性評價
格隆匯7月26日丨北陸藥業(300016.SZ)公佈,近日,公司收到國家藥品監督管理局頒發的關於釓噴酸葡胺注射液兩個規格的《藥品補充申請批准通知書》(通知書編號:2021B02267、2021B02268),該藥品通過仿製藥質量和療效一致性評價。
公司釓噴酸葡胺注射液1992年即獲得衞生部頒發的國家二類新藥證書;主要用於中樞神經(腦及脊髓)、腹、胸、盆腔、四肢等人體臟器和組織的磁共振成像;具有適應症廣泛、成像品質高的優點,臨牀使用效果反饋其增強效果優良,副反應較少。2020年,公司釓噴酸葡胺注射液銷售收入1.84億元。
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給予適當支持,醫療機構優先採購併在臨牀中優先選用。根據《國務院辦公廳關於推動藥品集中帶量採購工作常態化制度化開展的意見》(國辦發[2021]2 號),掛網藥品通過一致性評價的仿製藥數量超過3 個的,在確保供應的前提下,集中帶量採購不再選用未通過一致性評價的產品。
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