Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
JXHL1500131 | 盐酸西那卡塞 | cinacalcet hydrochloride | Active ingredient | Chemical Drugs | Import Drug Application | 2015-05-29 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2017-07-07 | view |
JXHL1800034 | 伊万卡塞片 | evocalcet | Tablet | Chemical Drugs(1) | Import Drug Application | 2018-03-07 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2018-07-27 | view |
JXHL1800035 | 伊万卡塞片 | evocalcet | Tablet | Chemical Drugs(1) | Import Drug Application | 2018-03-07 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2018-07-27 | view |
JXHS1100107 | 盐酸西那卡塞片 | cinacalcet hydrochloride | Tablet | Chemical Drugs | Import Drug Application | 2011-10-18 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2014-07-10 | view |
JXHS1100108 | 盐酸西那卡塞片 | cinacalcet hydrochloride | Tablet | Chemical Drugs | Import Drug Application | 2011-10-18 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2014-07-10 | view |
JXSL1000050 | 达依泊汀α注射液 | darbepoetin alfa | Injection | Biological Products | Import Drug Application | 2010-11-29 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2013-01-08 | view |
JXSL1000051 | 达依泊汀α注射液 | darbepoetin alfa | Injection | Biological Products | Import Drug Application | 2010-11-29 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2013-01-08 | view |
JXSL1000052 | 达依泊汀α注射液 | darbepoetin alfa | Injection | Biological Products | Import Drug Application | 2010-11-29 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2013-01-08 | view |
JXSL1000053 | 达依泊汀α注射液 | darbepoetin alfa | Injection | Biological Products | Import Drug Application | 2010-11-29 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2013-01-08 | view |
JXSL1000054 | 达依泊汀α注射液 | darbepoetin alfa | Injection | Biological Products | Import Drug Application | 2010-11-29 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2013-01-08 | view |
JXSL1000055 | 达依泊汀α注射液 | darbepoetin alfa | Injection | Biological Products | Import Drug Application | 2010-11-29 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2013-01-08 | view |
JXSL1100056 | 注射用贝那利珠单抗 | benralizumab | Lyophilized | Biological Products | Import Drug Application | 2011-11-02 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2013-06-26 | view |
JXSL1200070 | 注射用罗米司亭 | Romiplostim | Lyophilized | Biological Products | Import Drug Application | 2012-11-12 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2015-02-03 | view |
JXSL1700022 | 柏达鲁单抗注射液 | Injection | Biological Products | Import Drug Application | 2017-05-12 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2020-06-22 | view | |
JXSL1700039 | 布罗舒单抗注射液 | burosumab | Injection | Biological Products | Import Drug Application | 2017-07-24 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | In Review | 2017-07-22 | view |
JXSL1700040 | 布罗舒单抗注射液 | burosumab | Injection | Biological Products | Import Drug Application | 2017-07-24 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | In Review | 2017-07-22 | view |
JXSS1500001 | 达依泊汀α注射液 | darbepoetin alfa | Injection | Biological Products | Import Drug Application | 2015-04-10 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2016-04-12 | view |
JXSS1500002 | 达依泊汀α注射液 | darbepoetin alfa | Injection | Biological Products | Import Drug Application | 2015-04-10 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2016-04-12 | view |
JXSS1500003 | 达依泊汀α注射液 | darbepoetin alfa | Injection | Biological Products | Import Drug Application | 2015-04-10 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2016-04-12 | view |
JXSS1500004 | 达依泊汀α注射液 | darbepoetin alfa | Injection | Biological Products | Import Drug Application | 2015-04-10 | 协和发酵麒麟株式会社 | Kyowa Hakko Kirin Co Ltd | Certificate Issued | 2016-04-12 | view |