| Product No | EMEA/H/C/005352 |
|---|---|
| Brand Name | Upstaza |
| Nonproprietary Name | eladocagene exuparvovec |
| API | Eladocagene exuparvovec |
| ATC Code | A16AB26 |
| Indications | Upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic L amino acid decarboxylase (AADC) deficiency with a severe phenotype (see section 5.1). |
| Orphan Drug | yes |
| Generics | no |
| Marketing Authorization Holder | PTC Therapeutics International Limited |
| Status | Authorised(授权) |
| Authorization Date | 2022-07-18 |
| Version | 4 |
| Condition Approval | no |
| Exceptions | yes |
| 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