Natalizumab 300mg
| Product Overview | |
| Generic Name | Natalizumab 300mg |
| Brand Name(s) | Tysabri; Tyruko (natalizumab-sztn) |
| Form | Concentrate for solution for IV infusion |
| Strength | 300 mg/15 mL (20 mg/mL) |
| Therapeutic Class | Selective immunosuppressant; α4-integrin (adhesion-molecule) inhibitor |
| ATC Code | L04AA23 |
| Manufacturing & Regulatory | |
| Manufacturer | Biogen Netherlands B.V., Polpharma Biologics/Sandoz |
| Country | Netherlands/India |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | 072M2023 SSA |
| Free Sale Certificate | Available per batch upon request |
| Logistics & Export | |
| MOQ | 10 Vials |
| Shelf Life | 24 Months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes |
| SDS | Upon Request, not publicly posted |
| CTD Summary | Full CTD dossier proprietary; available under commercial agreement/license |
Description
Natalizumab is a humanized anti-α4 integrin monoclonal antibody that inhibits leukocyte adhesion/trafficking in the CNS. It is indicated as monotherapy for highly active multiple sclerosis (MS) and, in the US, under the REMS TOUCH program; historically, it has also been indicated for Crohn's disease.
