HERCEPTIN (trastuzumab 440mg)
Product Overview
| Generic Name | HERCEPTIN (trastuzumab 440mg) |
| Brand Name(s) | Herceptin |
| Category | Antibodies, monoclonal |
| Form | Vial, Intravenous infusion formulations—lyophilized pwd or sol. |
| Strength | 440mg |
| Therapeutic Class | Monoclonal antibody targeting HER2/neu (antineoplastic/immunomodulator) |
| ATC Code | L01FD01 |
Manufacturing & Regulatory
| Manufacturer | Roche/Genentech |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Type II |
| COFEPRIS | Clave: 010.000.5423.00 |
Logistics & Export
| MOQ | 10 units |
| Shelf Life | 24 months |
| Storage | 2–8 °C |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 to 10 Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | Not Avail. |
| CTD Summary (PDF) | Not publicly available as parallel traded molecule |
Special Notes
Brand HERCEPTIN; is a monoclonal antibody indicated for treatment of HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. Inhibiting tumor cell proliferation. Both 150mg and 440mg presentations are used based on dosing requirements and treatment protocols.