仙琚製藥(002332.SZ)收到醋酸潑尼松片一致性評價受理通知書
格隆匯 2 月 22日丨仙琚製藥(002332.SZ)公佈,公司於近日收到國家藥品監督管理局下發的醋酸潑尼松片一致性評價受理通知書。
醋酸潑尼松片有多年臨牀歷史,得到臨牀醫生、專家廣泛認可,並有多年數據累積,是用於治療過敏性與自身免疫性炎症性疾病常用且安全有效的藥物。適用於結締組織病,系統性紅斑狼瘡,嚴重的支氣管哮喘,皮肌炎,血管炎等過敏性疾病,急性白血病,惡性淋巴瘤以及適用於其他腎上腺皮質激素類藥物的病症等。
公司醋酸潑尼松片(規格為5mg)批准文號為:國藥準字H33021207,目前產品執行標準為《中國藥典》2020年版二部。
醋酸潑尼松片被國家藥品監督管理局藥品審評中心受理,標誌着該品種一致性評價工作進入了審評階段,公司將積極推進後續相關工作,如順利通過一致性評價將增加其市場競爭力。
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