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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1500030 SHR-1309注射液 pertuzumab Injection Biological Products(2) New Drug Application 2015-05-13 上海恒瑞医药有限公司 Shanghai Hengrui Pharmaceutical Co Ltd Certificate Issued 2017-02-21 view
CXSL1700090 帕妥珠单抗注射液 pertuzumab Injection Biological Products(2) New Drug Application 2017-10-18 正大天晴药业集团南京顺欣制药有限公司 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group Certificate Issued 2018-05-08 view
CXSL2101162 帕妥珠单抗注射液 pertuzumab Injection Biological Products(3.3) New Drug Application 2021-06-29 CSPC Megalith Biopharmaceutical Co Ltd view
CXSS2300002 帕妥珠单抗注射液 pertuzumab Injection Biological Products(3.3) New Drug Application 2023-01-10 QILU Pharmaceutical Co Ltd view
CXSS2300038 帕妥珠单抗注射液 pertuzumab Injection Biological Products(3.3) New Drug Application 2023-05-24 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
CXSS2400116 帕妥珠单抗注射液 pertuzumab Injection Biological Products(3.3) New Drug Application 2024-10-28 Hisun Biopharmaceutical Co Ltd view
JTS1900002 帕妥珠单抗注射液 pertuzumab Injection Biological Products Disposable Import Drug Application 2019-01-22 Roche Diagnostics GmbH Roche Diagnostics GmbH Certificate Issued 2019-02-26 view
JXSL0800003 帕妥珠单抗注射剂 pertuzumab Injection Biological Products Import Drug Application 2008-03-12 F.Hoffmann-La Roche Ltd. F Hoffmann-La Roche Ltd(Switzerland) Certificate Issued 2010-01-29 view
JXSL1100038 帕妥珠单抗注射液 pertuzumab Injection Biological Products Import Drug Application 2011-08-09 F.Hoffmann-La Roche Ltd. F Hoffmann-La Roche Ltd(Switzerland) Certificate Issued 2012-08-21 view
JXSL1200006 帕妥珠单抗注射液 pertuzumab Injection Biological Products Import Drug Application 2012-02-09 F.Hoffmann-La Roche Ltd. F Hoffmann-La Roche Ltd(Switzerland) Certificate Issued 2013-04-10 view
JXSL1200073 帕妥珠单抗注射液 pertuzumab Injection Biological Products Import Drug Application 2012-12-07 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2014-02-07 view
JXSL1300034 帕妥珠单抗注射液 pertuzumab Injection Biological Products Import Drug Application 2013-05-23 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2015-08-10 view
JXSL1300083 帕妥珠单抗 pertuzumab Injection Biological Products Import Drug Application 2014-01-03 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2015-10-19 view
JXSL1800044 帕妥珠单抗注射液 pertuzumab Injection Biological Products Import Drug Application 2018-10-29 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2018-10-26 view
JXSS1700018 帕妥珠单抗注射液 pertuzumab Injection Biological Products Import Drug Application 2018-01-02 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd Certificate Issued 2018-12-19 view
JXSS1800020 帕妥珠单抗注射液 pertuzumab Injection Biological Products Import Drug Application 2018-09-29 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2019-08-20 view
JXSS1800042 帕妥珠单抗注射液 pertuzumab Injection Biological Products Import Drug Application 2019-01-07 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2019-12-12 view
JXSS2200026 帕妥珠单抗曲妥珠单抗注射液(皮下注射) pertuzumab;trastuzumab Injection Biological Products(3.1) Import Drug Application 2022-07-27 view
JXSS2200027 帕妥珠单抗曲妥珠单抗注射液(皮下注射) pertuzumab;trastuzumab Injection Biological Products(3.1) Import Drug Application 2022-07-27 view
JYSB1800185 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2018-08-30 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2018-12-19 view