魯抗醫藥(600789.SH):注射用艾司奧美拉唑鈉獲得藥品註冊證書
格隆匯11月8日丨魯抗醫藥(600789.SH)公佈,近日,山東魯抗醫藥股份有限公司收到國家藥品監督管理局頒發的關於注射用艾司奧美拉唑鈉的《藥品註冊證書》(證書編號:2022S00876)。
注射用艾司奧美拉唑鈉用於胃食管反流病和急性胃或十二指腸潰瘍出血的低危患者;2007年,原研AstraZeneca AB的注射用艾司奧美拉唑鈉被中國被批准上市,商品名為“耐信/Nexium”,規格為40mg。國內上市規格為20mg、40mg。
2000年上市以來,艾司奧美拉唑鈉在全球多個國家和地區獲批。查詢國家藥監局官網獲悉,國內注射用艾司奧美拉唑鈉共有60個批准文號,涉及齊魯製藥、正大天晴等企業。
根據PDB數據庫信息,2021年中國樣本醫院注射用艾司奧美拉唑鈉合計銷售額約9.74億元。該產品於2022年7月納入第七批國家藥品集採。
截至公吿披露日,公司在該藥品的研發投入約為1644.09萬元人民幣(未經審計)。
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