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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXSL1500060 输注用Trastuzumab emtansine浓缩冻干粉 trastuzumab emtansine Lyophilized Biological Products Import Drug Application 2015-10-08 Roche Registration Limited Roche Registration Ltd Certificate Issued 2016-12-12 view
JXSL1500059 输注用Trastuzumab emtansine浓缩冻干粉 trastuzumab emtansine Lyophilized Biological Products Import Drug Application 2015-10-08 Roche Registration Limited Roche Registration Ltd Certificate Issued 2016-12-12 view
JXSL1700062 输注用Trastuzumab emtansine浓缩冻干粉 trastuzumab emtansine Lyophilized Biological Products Import Drug Application 2017-10-09 Roche Registration Limited Roche Registration Ltd Certificate Issued 2018-03-09 view
JXSL1700063 输注用Trastuzumab emtansine浓缩冻干粉 trastuzumab emtansine Lyophilized Biological Products Import Drug Application 2017-10-09 Roche Registration Limited Roche Registration Ltd Certificate Issued 2018-03-09 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
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
JXSL1900059 输注用Trastuzumab Emtansine浓缩冻干粉 trastuzumab emtansine Lyophilized Biological Products Import Drug Application 2019-07-22 F.Hoffmann-La Roche Ltd F Hoffmann-La Roche Ltd(Switzerland) In Review 2019-07-19 view
JXSL1900058 输注用Trastuzumab Emtansine浓缩冻干粉 trastuzumab emtansine Lyophilized Biological Products Import Drug Application 2019-07-22 F.Hoffmann-La Roche Ltd F Hoffmann-La Roche Ltd(Switzerland) In Review 2019-07-19 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
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
JYSB2000157 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2020-05-16 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd In Review 2020-05-15 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
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
JYSB2000158 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2020-05-16 上海罗氏制药有限公司 Shanghai Roche Pharmaceutical Co Ltd In Review 2020-05-15 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
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
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
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
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
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