| Product No | EMEA/H/C/000369 |
|---|---|
| Brand Name | Replagal |
| Nonproprietary Name | agalsidase alfa |
| API | agalsidase alfa |
| ATC Code | A16AB03 |
| Indications | Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase-A deficiency). |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Takeda Pharmaceuticals International AG Ireland Branch |
| Status | Authorised(授权) |
| Authorization Date | 2001-08-03 |
| Version | 28 |
| 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