普利製藥(300630.SZ):左乙拉西坦注射用濃溶液獲得西班牙藥品醫療器械管理局上市許可
格隆匯 11 月 29日丨普利製藥(300630.SZ)公佈,公司於近日收到了西班牙藥品與醫療器械管理局批准左乙拉西坦注射用濃溶液的上市許可。
左乙拉西坦注射用濃溶液是抗癲癇藥物,主要用於患者以下症狀發作時的輔助治療:4歲及以上兒童和成人癲癇患者的部分性癲癇發作的加用治療;12歲及以上青少年和成人癲癇患者的肌陣攣性癲癇發作的加用治療;12歲及以上兒童和成人患有特發性全身性癲癇發作的原發性強直陣攣發作的加用治療。
普利製藥的左乙拉西坦注射用濃溶液成功研發後進行了多國註冊申報,已分別於2016年11月獲得德國上市許可,2016年12月獲得荷蘭上市許可,2017年3月獲得美國上市許可,2019年9月獲得英國上市許可,2020年8月獲得國家藥品監督管理局的藥品註冊批件。在西班牙該產品的技術審評已於2020年10月14日結束,隨後進入西班牙國家階段的產品特性概要,説明書和標籤的審核和批件發放階段。
近日,公司收到了西班牙藥品與醫療器械管理局的上市許可,標誌着普利制藥具備了在西班牙銷售左乙拉西坦注射用濃溶液的資格,將對公司拓展市場帶來積極的影響。
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.