貴州百靈(002424.SZ):瑞康醫院收到醫療機構製劑註冊批件
格隆匯 3 月 25日丨貴州百靈(002424.SZ)公佈,公司於2018年1月5日與廣西中醫藥大學附屬瑞康醫院(“瑞康醫院”)簽訂《技術開發(合作)合同》,雙方擬共同參與醫療機構製劑“糖寧通絡膠囊”項目的研究和開發。
瑞康醫院於近日收到廣西壯族自治區藥品監督管理局下發的《醫療機構製劑註冊批件》。經審查,同意寧通絡膠囊按所附質量標準配製,按照《醫療機構製劑註冊管理辦法(試行)》、《廣西壯族自治區醫療機構製劑註冊管理實施細則》及有關規定,進一步觀察其療效、主治範圍及不良反應。詳細情況如下:
批件號:桂210020;製劑名稱:糖寧通絡膠囊;製劑類別:中藥;劑型:膠囊劑;製劑有效期:24個月;申請人單位名稱:廣西中醫藥大學附屬瑞康醫院;批准文號:桂藥制字Z20210002。
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