| Active substance | darolutamide |
| Holder | Bayer SA/NV |
| Status | Closed |
| Indication | Treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with ADT and docetaxel |
| Public documents | Approbation |
| Approbation amendment | |
| Information for the patient | |
| Informed consent | |
| Last update | 11/12/2023 |