紅日藥業(300026.SZ):鹽酸法舒地爾注射液通過一致性評價
格隆匯5月11日丨紅日藥業(300026.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,批准公司藥品鹽酸法舒地爾注射液通過仿製藥質量和療效一致性評價。
審批結論主要內容:經審查,本品通過仿製藥質量和療效一致性評價。同時同意以下變更:1.變更藥品處方和生產工藝;2.變更藥品質量標準。生產工藝、質量標準和説明書照所附執行,標籤相關內容應與説明書保持一致。有效期為24個月。
鹽酸法舒地爾及其注射液由日本旭化成和名古屋大學聯合開發,分別於1995年在日本上市和2001年在中國上市,主要用於蛛網膜下腔出血後腦血管痙攣等引起的缺血性腦血管疾病症狀的改善。
2004年旭化成在日本國內將鹽酸法舒地爾擴大到治療腦血栓的適應症,用於腦血栓急性期(發病後48小時內)的治療。歐洲藥品管理局於2020年7月批准鹽酸法舒地爾作為治療“非創傷性蛛網膜下腔出血的治療”的孤兒藥。
根據《中國蛛網膜下腔出血診治指南2019》,蛛網膜下腔出血(SAH)是指腦底部或腦表面血管破裂後,血液流入蛛網膜下腔引起相應臨牀症狀的一種腦卒中,佔所有腦卒中的5%~10%。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.