序号 | 受理号 | 药品名称 | 药品类型 | 申请类型 | 注册分类 | 企业名称 | 承办日期 |
1 | JYHS2300128 | 硫酸羟氯喹片 | 化药 | 进口 | 5.2 | Amneal EU, Limited;Amneal Pharmaceuticals Private Limited;Jiangsu Wanbang Pharmaceutical Marketing & Distribution Co., Ltd.; | 2023/11/17 |
2 | JXHS2300103 | 注射用氨曲南阿维巴坦钠 | 化药 | 进口 | 2.3 | Pfizer Europe MA EEIG;Hospira Australia Pty Ltd fizer Investment Co., Ltd.; | 2023/11/17 |
3 | JXHS2300102 | 磷奈匹坦帕洛诺司琼注射用浓溶液 | 化药 | 进口 | 5.1 | Helsinn Healthcare SA;Baxter Oncology GmbH;R&G PharmaStudies Co., Ltd.; | 2023/11/16 |
4 | JYHS2300127 | 枸橼酸西地那非片 | 化药 | 进口 | 5.2 | Hetero Labs Limited;Hetero Labs Limited;Hetero Pharma (Beijing) Co., Limited; | 2023/11/15 |
5 | JXSL2300196 | Amivan**ab注射液 | 治疗用生物制品 | 进口 | 2.2 | Janssen Research & Development, LLC;Johnson & Johnson (China) Investment Ltd.; | 2023/11/15 |
6 | JXHS2300101 | 二十碳五烯酸乙酯软胶囊 | 化药 | 进口 | 5.1 | Amarin Pharmaceuticals Ireland Ltd. atheon Softgels B.V.;不适用; | 2023/11/15 |
7 | JXHL2300290 | AZD5305 | 化药 | 进口 | 1 | AstraZeneca AB;AstraZeneca Investment (China) Co., Ltd.; | 2023/11/15 |
8 | JXHL2300289 | AZD5305 | 化药 | 进口 | 1 | AstraZeneca AB;AstraZeneca Investment (China) Co., Ltd.; | 2023/11/15 |
9 | JXHL2300288 | AZD5305 | 化药 | 进口 | 1 | AstraZeneca AB;AstraZeneca Investment (China) Co., Ltd.; | 2023/11/15 |
10 | JXHL2300287 | AZD5305 | 化药 | 进口 | 1 | AstraZeneca AB;AstraZeneca Investment (China) Co., Ltd.; | 2023/11/15 |
11 | JXHL2300286 | AZD9833片 | 化药 | 进口 | 1 | AstraZeneca AB;AstraZeneca Investment (China) Co. Limited; | 2023/11/15 |
12 | JXHL2300285 | Baxdrostat片 | 化药 | 进口 | 1 | AstraZeneca AB;AstraZeneca Global R&D (China) Co., Ltd.; | 2023/11/15 |
13 | JXHL2300284 | Lazertinib片 | 化药 | 进口 | 2.4 | Janssen Research & Development, LLC;Johnson & Johnson (China) Investment Ltd.; | 2023/11/15 |
14 | JXHL2300283 | Baxdrostat片 | 化药 | 进口 | 1 | AstraZeneca AB;AstraZeneca Global R&D (China) Co., Ltd.; | 2023/11/15 |
15 | JXHL2300282 | Ganaxolone注射剂 | 化药 | 进口 | 2.2;2.4 | Marinus Pharmaceuticals, Inc.;Tenacia Biotechnology (Shanghai) Co., Ltd; | 2023/11/15 |
16 | JXSS2300084 | 注射用利纳西普(暂定) | 治疗用生物制品 | 进口 | 3.1 | Kiniksa Pharmaceuticals (UK),Ltd.;Jubilant HollisterStier LLC;HANGZHOU ZHONGMEI HUADONG PHARMACEUTICALS CO. ,LTD; | 2023/11/14 |
17 | JXSL2300195 | Alnuc**ab注射液 | 治疗用生物制品 | 进口 | 1 | Celgene International II Sarl;Bristol-Myers Squibb (China) Investment Co., Ltd.; | 2023/11/14 |
18 | JXSL2300194 | Alnuc**ab注射液 | 治疗用生物制品 | 进口 | 1 | Celgene International II Sarl;Bristol-Myers Squibb (China) Investment Co., Ltd.; | 2023/11/14 |
19 | JXSL2300193 | RO7538483注射液 | 治疗用生物制品 | 进口 | 1 | F. Hoffmann -La Roche Ltd;Roche (China) Holding Ltd; | 2023/11/14 |