| Product No | EMEA/H/C/001021 |
|---|---|
| Brand Name | Adcirca (previously Tadalafil Lilly) |
| Nonproprietary Name | tadalafil |
| API | tadalafil |
| ATC Code | G04BE08 |
| Indications | Adcirca is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organization functional class II and III, to improve exercise capacity (see section 5.1).Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Eli Lilly Nederland B.V. |
| Status | Authorised(授权) |
| Authorization Date | 2008-10-01 |
| Version | 15 |
| 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