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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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;Utsunomiya Plant Of Chugai Pharma Manufacturing Co Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2020-05-14 view
JYHB1400897 甲磺酸沙奎那韦胶囊 saquinavir mesylate Capsule Chemical Drugs Supplementary Application 2014-07-04 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Farma SA;Roche Pharma (Schweiz) Ltd Certificate Issued 2016-02-15 view
JYSB1900336 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2019-12-04 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd Certificate Issued 2020-01-22 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;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd In Review 2022-01-20 view
JXSL1900051 注射用 Polatuzumab vedotin polatuzumab vedotin Lyophilized Biological Products Import Drug Application 2019-05-20 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2019-05-17 view
JXHL1900176 Idasanutlin片 idasanutlin Tablet Chemical Drugs(1) Import Drug Application 2019-07-31 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2019-07-30 view
JXHB2000053 GDC-0077 inavolisib Active ingredient Chemical Drugs(1) Supplementary Application 2020-11-23 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2020-11-21 view
JYSB1800256 阿替利珠单抗注射液 atezolizumab Injection Biological Products Supplementary Application 2018-12-03 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Diagnostics GmbH;F Hoffmann-La Roche Ltd(Switzerland) In Review 2018-11-30 view
JXSL2000085 Gantenerumab注射液 gantenerumab Injection Biological Products Import Drug Application 2020-07-03 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2020-07-02 view
JXSL1700077 Emicizumab注射液 emicizumab Injection Biological Products Import Drug Application 2017-12-04 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) Certificate Issued 2018-12-04 view
JYSB2000195 Gantenerumab注射液 gantenerumab Injection Biological Products Supplementary Application 2020-05-27 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Genentech Inc;F Hoffmann-La Roche Ltd(Switzerland) In Review 2020-05-26 view
JYSB1500219 贝伐珠单抗注射液 bevacizumab Injection Biological Products Supplementary Application 2015-09-09 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Diagnostics GmbH;Roche Pharma (Schweiz) Ltd Certificate Issued 2015-12-04 view
JXHL2000013 Idasanutlin片 idasanutlin Tablet Chemical Drugs(1) Import Drug Application 2020-02-15 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2020-02-14 view
JXSS2100023 贝伐珠单抗注射液 bevacizumab Injection Biological Products(3.1) Import Drug Application 2021-04-07 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Diagnostics GmbH;Roche Pharma (Schweiz) AG Certificate Issued 2021-11-19 view
JYSB1300248 贝伐珠单抗注射液 bevacizumab Injection Biological Products Supplementary Application 2013-11-21 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Diagnostics GmbH;Roche Pharma (Schweiz) Ltd Certificate Issued 2014-07-03 view
JYHZ1900224 马来酸咪达唑仑片 midazolam maleate Tablet Chemical Drugs License Renew 2019-08-17 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Pharma (Schweiz) Ltd Certificate Issued 2019-12-20 view
JXSB2000043 Gantenerumab注射液 gantenerumab Injection Biological Products(1) Supplementary Application 2020-12-14 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2020-12-03 view
JYHB1900277 注射用更昔洛韦 ganciclovir Lyophilized Chemical Drugs Supplementary Application 2019-03-04 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;BSP Pharmaceuticals Srl;Roche Pharma (Schweiz) AG Filed 2019-03-13 view
JXSL2000119 Gantenerumab注射液 gantenerumab Injection Biological Products Import Drug Application 2020-07-08 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2020-07-07 view
JXHL2000264 Ipatasertib片 ipatasertib Tablet Chemical Drugs(1) Import Drug Application 2020-09-24 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland) In Review 2020-09-23 view