| Product No | EMEA/H/C/005501 |
|---|---|
| Brand Name | Nexviadyme |
| Nonproprietary Name | Avalglucosidase alfa |
| API | Avalglucosidase alfa |
| ATC Code | A16 |
| Indications | Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid α-glucosidase deficiency). |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Sanofi B.V. |
| Status | Authorised(授权) |
| Authorization Date | 2022-06-24 |
| Version | 1 |
| 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