Brentuximab Vedotin 50mg
| Product Overview | |
| Generic Name | Brentuximab Vedotin 50mg |
| Brand Name(s) | ADCETRIS® |
| Form | Powder for concentrate for solution for infusion; single-use vial; intravenous use |
| Strength | 50 mg, 5mg/mL |
| Therapeutic Class | Antineoplastic agent; monoclonal antibody and antibody-drug conjugate (CD30-directed ADC) |
| ATC Code | L01FX05 |
| Manufacturing & Regulatory | |
| Manufacturer | Seagen Inc. |
| Country | Bothell, Washington, USA |
| GMP Compliance | WHO-GMP, EU-GMP |
| COFEPRIS | 010.000.6085.00 |
| Free Sale Certificate | available through Takeda/Seagen/Pfizer authorised channels |
| Logistics & Export | |
| MOQ | 10 Units |
| Shelf Life | 48 months / 4 years |
| Storage | 2–8 °C in fridge; do not freeze; |
| Incoterms | EXW |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | available through authorised manufacturer/distributor channels |
| SDS | SDS / hazardous-drug handling sheet from Seagen/Pfizer/Takeda |
| CTD Summary | Full CTD/eCTD Modules 2–5 are proprietary and not provided freely |
Description
A CD30-directed antibody-drug conjugate used in selected CD30-positive lymphomas, including classical Hodgkin lymphoma, systemic anaplastic large cell lymphoma, certain CD30-expressing peripheral T-cell lymphomas, primary cutaneous anaplastic large cell lymphoma, CD30-expressing mycosis fungoides, and relapsed/refractory large B-cell lymphoma in combination regimens.
