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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXSL1900066 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Import Drug Application 2019-08-01 美信美达医药信息咨询(北京)有限责任公司 Meixin Meida Medical Information Consulting (Beijing) Co Ltd In Review 2019-07-31 view
JXSS2000017 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Import Drug Application 2020-05-27 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2020-05-26 view
JYSB2000654 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2020-12-25 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Filed 2021-01-06 view
JXSS1900013 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Import Drug Application 2019-03-27 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2020-01-22 view
JYSB2000426 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2020-09-01 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Filed 2020-09-11 view
JYSB2000332 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2020-06-30 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Filed 2020-07-01 view
JXSS1900012 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Import Drug Application 2019-03-27 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2020-01-22 view
JYSB2000194 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2020-05-16 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Filed 2020-05-25 view
JYSB2000331 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2020-06-30 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Filed 2020-07-01 view
JYSB2000193 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2020-05-16 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Filed 2020-05-25 view
JYSB2000425 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2020-09-01 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Filed 2020-09-11 view
JXSS2000016 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Import Drug Application 2020-05-27 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2020-05-26 view
JYSB2000653 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2020-12-25 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Filed 2021-01-06 view
JTS1900038 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Disposable Import Drug Application 2019-08-03 瑞士罗氏制药有限公司F. Hoffman-La Roche Ltd F Hoffmann-La Roche Ltd(Switzerland) Certificate Issued 2019-09-04 view
JTS1900039 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Disposable Import Drug Application 2019-08-03 瑞士罗氏制药有限公司 F. Hoffman-La Roche Ltd. F Hoffmann-La Roche Ltd(Switzerland) Certificate Issued 2019-09-04 view
JXSL0900083 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Import Drug Application 2009-12-04 深圳万乐药业有限公司 Shenzhen Main Luck Pharmaceuticals INC Certificate Issued 2011-03-07 view
CXSL1400013 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products(2) New Drug Application 2014-04-30 正大天晴药业集团股份有限公司 Jiangsu Chia Tai-Tianqing Pharmaceutical Co Ltd Certificate Issued 2016-09-26 view
CXSL1400077 注射用重组抗人表皮生长因子受体2(HER2)单抗(曲妥珠单抗) trastuzumab Lyophilized Biological Products(2) New Drug Application 2014-09-12 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd Certificate Issued 2016-07-21 view
JXSL1900088 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Import Drug Application 2019-09-11 上海艾迈医疗科技有限公司 7 Items of Kangqiao Capital Questionnaire 2019q4 Affamedtherapeutics Limited In Review 2019-09-10 view
JYSB0600001 注射用曲妥珠单抗 trastuzumab Lyophilized Biological Products Supplementary Application 2006-01-12 上海罗氏制药有限公司北京办事处 Shanghai Roche Pharmaceuticals Ltd Beijing Certificate Completed-Pending Issued 2006-05-30 view