| Product No | EMEA/H/C/004297 |
|---|---|
| Brand Name | Talmanco (previously Tadalafil Generics) |
| Nonproprietary Name | tadalafil |
| API | tadalafil |
| ATC Code | G04BE08 |
| Indications | Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. |
| Orphan Drug | no |
| Generics | yes |
| Marketing Authorization Holder | Viatris Limited |
| Status | Authorised(授权) |
| Authorization Date | 2017-01-09 |
| Version | 7 |
| 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