| Product No | EMEA/H/C/000785 |
|---|---|
| Brand Name | Irbesartan Zentiva (previously Irbesartan Winthrop) |
| Nonproprietary Name | irbesartan |
| API | irbesartan |
| ATC Code | C09CA04 |
| Indications | Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Zentiva k.s. |
| Status | Authorised(授权) |
| Authorization Date | 2007-01-19 |
| 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