TECENTRIQ® (atezolizumab) 1200 mg
Product Overview
| Generic Name | TECENTRIQ® (atezolizumab) 1200 mg |
| Brand Name(s) | Tecentriq® |
| Category | Antibodies, monoclonal |
| Form | Intravenous injection (liquid, vial) |
| Strength | 1200 mg vial |
| Therapeutic Class | PD‑L1 inhibitor immunotherapy |
| ATC Code | L01XC32 |
Manufacturing & Regulatory
| Manufacturer | Hoffmann‑La Roche / Genentech |
| GMP Compliance | FDA/EMA/WHO-GMP |
| DMF/CEP | Not public—Type II for biologics |
| COFEPRIS | 010.000.6193.00 |
| Free Sale Certificate | may obtain export certificate from regulatory authority |
Logistics & Export
| MOQ | 5 vials |
| Shelf Life | 24 Months |
| Storage | 2 – 8 °C cold chain |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 10–21 days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Supplied by Roche/Genentech; distributors also issue COA |
| SDS-Safety Data Sheet (PDF) | Upon Request |
| CTD Summary (PDF) | CTD proprietary; available under commercial agreement/license |
Special Notes
Indications & Usage: Fully human IgG1 anti-PD‑L1 monoclonal antibody indicated in adults for: Urothelial carcinoma (initial indication), Advanced NSCLC (monotherapy and in combination regimens) Extensive-stage SCLC (with chemo) Hepatocellular carcinoma (with bevacizumab) and also approved for metastatic melanoma, alveolar soft part sarcoma; first PD‑L1 antibody worldwide