羅欣藥業(002793.SZ):鹽酸氨溴索注射液首家通過一致性評價
格隆匯12月4日丨羅欣藥業(002793.SZ)公佈,公司下屬子公司山東羅欣藥業集團股份有限公司(“山東羅欣”)於近日收到國家藥品監督管理局核准簽發的“鹽酸氨溴索注射液”《藥品補充申請批准通知書》,批准該藥品首家通過仿製藥質量和療效一致性評價(“一致性評價”)。
藥品名稱:鹽酸氨溴索注射液;劑型:注射劑;註冊分類:化學藥品;規格:1ml:7.5mg;2ml:15mg;4ml:30mg;原藥品批准文號:國藥準字H20153115;國藥準字H20133025;國藥準字H20133026;藥品註冊標準編號:YBH14102020;申請人:山東羅欣藥業集團股份有限公司;通知書編號:2020B05133;2020B05134;2020B05135;審批結論:根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發﹝2015﹞44號)、《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)和《國家藥監局關於開展化學藥品注射劑仿製藥質量和療效一致評價工作的公告》(2020年第62號)的規定,經審查,本品通過仿製藥質量和療效一致性評價。
在遞交鹽酸氨溴索注射液一致性評價註冊申請的企業中,公司為首家通過一致性評價的藥品上市許可持有人。根據國家相關政策,通過一致性評價的藥品品種,質量和療效等同原研產品,在醫保支付及醫療機構採購方面將予以適當支持。鹽酸氨溴索注射液在公司呼吸系統疾病藥品中佔有重要地位,此次過評體現了公司在該領域的技術優勢,有利於提升市場競爭力,擴大市場份額,進一步鞏固該藥品的優勢地位,同時也將為公司後續一致性評價工作積累寶貴經驗。
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