Tocilizumab 80mg
Product Overview
| Generic Name | Tocilizumab 80mg |
| Brand Name(s) | Actemra / RoActemra |
| Category | Antibodies, monoclonal |
| Form | Intravenous infusion solution (single-dose vials) |
| Strength | 80 mg/4 mL |
| Therapeutic Class | Interleukin-6 (IL-6) receptor antagonist; immunosuppressant / antirheumatic |
| ATC Code | L04AC07 |
Manufacturing & Regulatory
| Manufacturer | Genentech, Others in Biosimilars |
| 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 Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | Upon Request, not publicly posted |
| CTD Summary (PDF) | Full CTD dossier proprietary; available under commercial agreement/license |
Special Notes
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.