| Active ingredient (INN) | Rituximab |
|---|---|
| Brand names | Rituxan, Truxima, MabThera, Ruxience |
| ATC level 5 | L01FA01 |
| ATC level 4 | L01FA |
| Drug class | Anti-CD20 monoclonal antibody |
| Therapeutic category | Oncology/Immunology |
| Strength | 100mg/10ml · 500mg/50ml |
| Dosage form | concentrate for infusion |
| Route of administration | intravenous |
| WHO Essential Medicine | Yes (2023) |
| Controlled substance | No |
| Marketing-authorisation holders | Pfizer Australia Pty Ltd, Sandoz Pty Ltd, Mabion Spolka Akcyjna |
| Registrations on file | 7 |
| Patient information leaflet (PIL) | Not on file |
| Summary of product characteristics (SPC) | Not on file |
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| TRUXIMA rituximab | 500 mg | — | 🇦🇺 AU | — | Active |
| RUXIENCE Rituximab | 100mg | — | 🇦🇺 AU | Pfizer Australia Pty Ltd | Active |
| RUXIENCE Rituximab | 500mg | — | 🇦🇺 AU | Pfizer Australia Pty Ltd | Active |
| RIXIMYO rituximab | 500mg | — | 🇦🇺 AU | Sandoz Pty Ltd | Active |
| RIXIMYO rituximab | 100mg | — | 🇦🇺 AU | Sandoz Pty Ltd | Active |
| TRUXIMA rituximab | 100 mg | — | 🇦🇺 AU | — | Active |
| Rituximab Mabion | — | — | 🌐 EU | Mabion Spolka Akcyjna | Application withdrawn |