| Product No | EMEA/H/C/003787 |
|---|---|
| Brand Name | Tadalafil Mylan |
| Nonproprietary Name | tadalafil |
| API | tadalafil |
| ATC Code | G04BE08 |
| Indications | Treatment of erectile dysfunction in adult males.,In order for tadalafil to be effective, sexual stimulation is required.,Tadalafil Mylan is not indicated for use by women., |
| Orphan Drug | no |
| Generics | yes |
| Marketing Authorization Holder | Mylan Pharmaceuticals Limited |
| Status | Authorised(授权) |
| Authorization Date | 2014-11-21 |
| Version | 14 |
| 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