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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYSB2400206 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2024-09-12 Roche Pharma (Schweiz) AG;F Hoffmann-La Roche Ltd(Switzerland) view
JYSB2400207 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2024-09-12 Roche Pharma (Schweiz) AG;F Hoffmann-La Roche Ltd(Switzerland) view
JYSB2400191 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2024-08-26 F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG view
JYSB2400190 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2024-08-26 Roche Pharma (Schweiz) AG;F Hoffmann-La Roche Ltd(Switzerland) view
JYSZ2400033 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products License Renew 2024-06-21 F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG;Roche (China) Holding Ltd view
JYSZ2400034 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products License Renew 2024-06-21 Roche Pharma (Schweiz) AG;F Hoffmann-La Roche Ltd(Switzerland);Roche (China) Holding Ltd view
JYSB2300156 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2023-09-12 F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG view
JYSB2300155 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2023-09-12 F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG view
JTS2200110 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Disposable Import Drug Application 2022-12-31 Roche Müstehtarlar Sanayi Anonim;Shanghai Fosun Pharmaceutical Industrial Development Co Ltd;F Hoffmann-La Roche Ltd(Switzerland) view
JYSB2200018 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2022-02-11 F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG view
JYSB2200017 注射用恩美曲妥珠单抗 trastuzumab emtansine Lyophilized Biological Products Supplementary Application 2022-02-11 Roche Pharma (Schweiz) AG;F Hoffmann-La Roche Ltd(Switzerland) 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;F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG Filed 2021-01-06 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;Roche Pharma (Schweiz) AG;F Hoffmann-La Roche Ltd(Switzerland) Filed 2021-01-06 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;F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG Filed 2020-09-11 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;F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG 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;F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG Filed 2020-07-01 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;Roche Pharma (Schweiz) AG;F Hoffmann-La Roche Ltd(Switzerland) Filed 2020-07-01 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;F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG 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;F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG In Review 2020-05-26 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;F Hoffmann-La Roche Ltd(Switzerland);Roche Pharma (Schweiz) AG Filed 2020-05-25 view