| Product No | EMEA/H/C/004854 |
|---|---|
| Brand Name | Hepcludex |
| Nonproprietary Name | bulevirtide |
| API | Bulevirtide acetate |
| ATC Code | J05A |
| Indications | Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease. |
| Orphan Drug | yes |
| Generics | no |
| Marketing Authorization Holder | Gilead Sciences Ireland UC |
| Status | Authorised(授权) |
| Authorization Date | 2020-07-31 |
| Version | 9 |
| Condition Approval | yes |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information