| Product No | EMEA/H/C/000636 |
|---|---|
| Brand Name | Myozyme |
| Nonproprietary Name | alglucosidase alfa |
| API | alglucosidase alfa |
| ATC Code | A16AB07 |
| Indications | Myozyme is indicated for long-term enzyme-replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid-α-glucosidase deficiency).In patients with late-onset Pompe disease the evidence of efficacy is limited. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Sanofi B.V. |
| Status | Authorised(授权) |
| Authorization Date | 2006-03-28 |
| Version | 24 |
| 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