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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYSB2000688 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
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;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd In Review 2019-08-06 view
JYSZ2300015 艾美赛珠单抗注射液 emicizumab Injection Biological Products License Renew 2023-03-30 Roche Pharma (Schweiz) AG;Roche (China) Holding Ltd;Chugai Pharma Manufacturing Co Ltd view
JYSB2200167 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2022-08-30 Roche Pharma (Schweiz) AG;Chugai Pharma Manufacturing Co Ltd 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;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd Certificate Issued 2020-06-10 view
JYSB2500073 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2025-03-20 Roche Pharma (Schweiz) AG;Chugai Pharma Manufacturing Co Ltd view
JYSB2101179 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2021-11-29 Roche Pharma (Schweiz) AG;Chugai Pharma Manufacturing Co Ltd view
JYSB2000411 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2020-08-21 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 Filed 2020-09-02 view
JYSB1900129 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;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd Certificate Issued 2019-10-17 view
JYSB2300045 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2023-03-08 Roche Pharma (Schweiz) AG;Chugai Pharma Manufacturing Co Ltd view
JYSB2000693 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
JYSB1900334 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
JYSB2500067 艾美赛珠单抗注射液 emicizumab Injection Biological Products(1) Supplementary Application 2025-03-18 Roche Pharma (Schweiz) AG view
JYSB2101059 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2021-06-25 Roche Pharma (Schweiz) AG;Chugai Pharma Manufacturing Co Ltd view
JXSS2000014 艾美赛珠单抗注射液 emicizumab Injection Biological Products Import Drug Application 2020-05-23 罗氏(中国)投资有限公司 Roche (China) Holding Ltd;Roche Pharma (Schweiz) AG;Chugai Pharma Manufacturing Co Ltd In Review 2021-03-30 view
CXSL2300015 艾美赛珠单抗注射液 emicizumab Injection Biological Products(3.3) New Drug Application 2023-01-06 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd view
JYSZ2300018 艾美赛珠单抗注射液 emicizumab Injection Biological Products License Renew 2023-03-30 Roche Pharma (Schweiz) AG;Roche (China) Holding Ltd;Chugai Pharma Manufacturing Co Ltd 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
JYSB1900333 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
JYSB2500074 艾美赛珠单抗注射液 emicizumab Injection Biological Products Supplementary Application 2025-03-20 Roche Pharma (Schweiz) AG;Chugai Pharma Manufacturing Co Ltd view