Registration No. | 国药准字SJ20200025 |
---|---|
Registration No. Remarks | 受理号为JYSB2000153的补充申请内容为增加商品名,此次一并批准,不再另行发给批件。 |
Drug Name(Chinese) | 拉那利尤单抗注射液 |
Drug Name(English) | Lanadelumab Injection |
Proprietary Name(Chinese) | 达泽优 |
Proprietary Name(English) | 暂无权限 |
Drug Sandard Code(Chines) | 86983281000016 |
Manufacturers(English) | Catalent Indiana, LLC |
Production Address(English) | 1300 South Patterson Drive, Bloomington, IN 47403, United States of America |
State(Chinese) | 美国 |
State(English) | USA |
Dosage Form | 注射剂 |
Strength | 300mg/2ml(150mg/ml) |
Packaging | 1瓶/盒 |
Date Issued | 2020-12-02 |
Valid Until | 2025-12-01 |
Category | 生物制品 |
Extended Information