HERCEPTIN (Trastuzumab 150mg )
Product Overview
| Generic Name | HERCEPTIN (Trastuzumab 150mg ) |
| Brand Name(s) | Herceptin |
| Category | Antibodies, monoclonal |
| Form | Vial, Intravenous infusion formulations—lyophilized pwd or sol. |
| Strength | 150 mg |
| 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
| 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.Cofepris approvals to Zydus Lifesciences Ltd (Mamitra)