浙江震元(000705.SZ):注射用艾司奧美拉唑鈉獲藥品註冊證書
格隆匯 8 月 3日丨浙江震元(000705.SZ)公告,公司的全資子公司浙江震元製藥有限公司(以下簡稱“震元製藥”)於日前收到國家藥品監督管理局批准簽發的“注射用艾司奧美拉唑鈉”《藥品註冊批書》,具體內容如下:
藥品通用名稱:注射用艾司奧美拉唑鈉
英文名/拉丁名:EsomeprazoleSodiumforInjection
主要成分:艾司奧美拉唑鈉
劑型:注射劑
申請事項:藥品註冊(境內生產)
規格:20mg(以C17H19N3O3S計)
註冊分類:原化學藥品第6類
藥品註冊標準編號:YBH02322020
藥品有效期:24個月
上市許可持有人:浙江震元製藥有限公司
生產企業:浙江震元製藥有限公司
藥品批准文號:國藥準字H20203330
藥品批准文號有效期:至2025年7月20日
注射用艾司奧美拉唑鈉適應症:作為口服療法不適用時,胃食管反流病的替代療法;用於口服療法不適用的急性胃或十二指腸潰瘍出血的低危患者(胃鏡下Forrest分級IIc-III)。
本次注射用艾司奧美拉唑鈉獲批後,充實了子公司震元製藥產品線,震元製藥將根據市場需求情況,安排生產上市。該產品未來的具體銷售情況可能受到行業政策、市場環境等因素影響,具有不確定性,敬請廣大投資者謹慎決策,注意防範投資風險。
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