| Active ingredient (INN) | Denosumab |
|---|---|
| Brand names | Prolia, Bildyos, Bilprevda |
| ATC level 5 | M05BX04 |
| ATC level 4 | M05BX |
| Therapeutic category | Auto-created by FDA Drug Enforcement — Full Recall Database scraper |
| Controlled substance | No |
| Marketing-authorisation holders | Amgen Australia Pty Ltd, CELLTRION USA, Inc., Intas Third Party Sales 2005 S.L. |
| Registrations on file | 5 |
| Patient information leaflet (PIL) | Not on file |
| Summary of product characteristics (SPC) | Not on file |
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| PROLIA denosumab | 60mg | — | 🇦🇺 AU | Amgen Australia Pty Ltd | Active |
| XGEVA denosumab | 70mg | — | 🇦🇺 AU | Amgen Australia Pty Ltd | Active |
| Denosumab-BMWO | 60mg/mL | injection | 🇺🇸 US | CELLTRION USA, Inc. | Active |
| Denosumab-BMWO | 120mg/1.7mL | injection | 🇺🇸 US | CELLTRION USA, Inc. | Active |
| Denosumab Intas | — | — | 🌐 EU | Intas Third Party Sales 2005 S.L. | Active |