作为扬子江药业集团在欧盟获批的第二款产品（首款为2024年8月获批的盐酸右美托咪定注射液），注射用帕瑞昔布钠的海外市场布局正逐步扩大。截至目前，该产品已在澳大利亚、马来西亚、荷兰、乌兹别克斯坦、塔吉克斯坦、英国、秘鲁7个国家获得上市许可。该产品以荷兰为主审国、德国为相关国，通过分散审评程序（DCP）完成主程序后，国际注册团队于6月迅速启动两国的国家程序。目前，荷兰官方已率先发放获批证书，德国的获批证书也预计将在半月内落地。后续欧盟其他28个国家的市场准入，可通过互认审评程序（MRP）完成，此举将大幅缩短审评周期至90天，为产品快速覆盖欧盟市场奠定基础。
Parecoxib Sodium for Injection, Yangtze River Pharmaceutical Group's second EU-approved product (following Dexmedetomidine Hydrochloride Injection in August 2024), is expanding its overseas presence. It has gained marketing approval in 7 countries: Australia, Malaysia, the Netherlands, Uzbekistan, Tajikistan, the UK and Peru.With the Netherlands as the reference state and Germany as the concerned state, the product completed the Decentralized Procedure (DCP). The international registration team launched national procedures for both in June. The Netherlands has issued the approval, with Germany's expected within half a month.Market access in the other 28 EU countries can be via the Mutual Recognition Procedure (MRP), shortening the review period to 90 days and facilitating rapid EU market coverage.
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