| Product No | EMEA/H/C/000261 |
|---|---|
| Brand Name | Hepacare |
| Nonproprietary Name | hepatitis B surface antigens recombinant (S, pre-S1, pre-S2) adsorbed on aluminium hydroxide [produced on genetically engineered murine (C127I) cells] |
| API | hepatitis B surface antigens recombinant (S, pre-S1, pre-S2) adsorbed on aluminium hydroxide [produced on genetically engineered murine (C127I) cells] |
| ATC Code | J07BC |
| Indications | This vaccine is indicated for active immunisation against hepatitis B virus infection in non-immune adults (>=18 years). The specific at risk categories to be immunised are to be determined on the basis of official recommendations. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Evans Vaccines Ltd. |
| Status | Withdrawn |
| Authorization Date | 2000-08-04 |
| Version | 0 |
| Condition Approval | no |
| 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