| Product No | EMEA/H/C/002788 |
|---|---|
| Brand Name | Jinarc |
| Nonproprietary Name | tolvaptan |
| API | Tolvaptan |
| ATC Code | C03XA01 |
| Indications | Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Otsuka Pharmaceutical Netherlands B.V. |
| Status | Authorised(授权) |
| Authorization Date | 2015-05-27 |
| Version | 20 |
| 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