Tocilizumab 400mg
| Product Overview | |
| Generic Name | Tocilizumab 400mg |
| Brand Name(s) | Actemra / RoActemra |
| Form | Intravenous infusion solution (single-dose vials) |
| Strength | 400 mg/20 mL (20mg/mL) |
| Therapeutic Class | Interleukin-6 (IL-6) receptor antagonist; immunosuppressant / antirheumatic |
| ATC Code | L04AC07 |
| Manufacturing & Regulatory | |
| Manufacturer | Genentech, Others in Biosimilars |
| Country | US/Japan/India/Mexico |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not applicable |
| COFEPRIS | 010.000.4516.00 |
| Free Sale Certificate | Available per batch upon request |
| Logistics & Export | |
| MOQ | 10 Vials |
| Shelf Life | 24 Months |
| Storage | Refrigerated (2–8 °C) |
| Incoterms | EXW/CIF negotiable |
| Lead Time | 1-2 Weeks |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Upon Request, not publicly posted |
| CTD Summary | Full CTD dossier proprietary; available under commercial agreement/license |
Description
Indications Uses: Moderate to severe rheumatoid arthritis (RA) / Systemic juvenile idiopathic arthritis (sJIA) and polyarticular juvenile idiopathic arthritis (pJIA) / Giant cell arteritis (GCA) / Cytokine release syndrome (CRS) Off-label Special Situations: Severe COVID-19 pneumonia with evidence of systemic inflammation (IL-6 driven) other rare auto-inflammatory disorders.
