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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
JYSB1900197 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2019-08-07 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2019-08-06 view
JXSL1400029 Lebrikizumab注射液 lebrikizumab Injection Biological Products Import Drug Application 2014-04-29 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2015-12-10 view
JXSL2000086 RO7082859 glofitamab Injection Biological Products Import Drug Application 2020-07-03 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2020-07-02 view
JXSL1900043 注射用Polatuzumab vedotin polatuzumab vedotin Lyophilized Biological Products Import Drug Application 2019-04-22 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2019-04-19 view
JXHS2000075 玛巴洛沙韦片 baloxavir marboxil Tablet Chemical Drugs(5.1) Import Drug Application 2020-06-10 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2020-06-09 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
JYHB2002697 马来酸咪达唑仑片 midazolam maleate Tablet Chemical Drugs Supplementary Application 2020-12-28 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2021-02-24 view
JYSB2000080 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2020-03-25 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2020-06-10 view
JXSL1700025 Crenezumab注射液 crenezumab Injection Biological Products Import Drug Application 2017-05-31 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2018-01-17 view
JXSL2000162 奥妥珠单抗注射液 obinutuzumab Injection Biological Products(2.2) Import Drug Application 2020-09-27 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2020-09-25 view
JXSL1900100 阿替利珠单抗注射液 atezolizumab Injection Biological Products Import Drug Application 2019-09-28 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2019-09-27 view
JYHB1401587 马来酸咪达唑仑片 midazolam maleate Tablet Chemical Drugs Supplementary Application 2014-12-09 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2015-07-06 view
JYSB2000386 帕妥珠单抗注射液 pertuzumab Injection Biological Products Supplementary Application 2020-08-21 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Filed 2020-09-02 view
JYSB1900131 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2019-06-19 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2019-10-17 view
JYSB2000246 阿替利珠单抗注射液 atezolizumab Injection Biological Products Supplementary Application 2020-06-20 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2020-06-19 view
JYHB1900200 伊班膦酸注射液 ibandronate sodium Injection Chemical Drugs Supplementary Application 2019-02-25 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2019-03-25 view
JYSB2000694 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2021-01-01 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2022-01-20 view
JXSS2000011 Satralizumab注射液 satralizumab Injection Biological Products Import Drug Application 2020-05-15 罗氏(中国)投资有限公司 Roche (China) Holding Ltd In Review 2020-05-14 view
JXSL1700083 Gantenerumab注射液 gantenerumab Injection Biological Products Import Drug Application 2017-12-04 罗氏(中国)投资有限公司 Roche (China) Holding Ltd Certificate Issued 2018-08-27 view