Natalizumab
Therapeutic Natalizumab antibody from the original Tysabri® commercial drug.
Reference Standard as Aliquots
Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot | Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2028.05 |
Tysabri® DE |
4 mg |
Unit: aliquot(s) |
241,00 €/aliquot
|
Biosimilars as Aliquots
Access Batch Specific Analytical Information
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Product Information
Here you will find the product information for the reference product.
Tysabri® / Natalizumab Reference Product
| Drug name | Tysabri® |
| INN | Natalizumab |
| API type | Natalizumab is a recombinant humanised anti-α4-integrin antibody produced in a murine cell line by recombinant DNA technology. |
| Pharmacotherapeutic group | Immunosuppressants, selective immunosuppressants. |
| ATC code | L04AA23 |
| Target of antibody | α4-integrin |
| General function | Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS). |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Natalizumab blocks the interaction of α4β7 integrin with the mucosal addressin cell adhesion molecule-1 (MadCAM-1). Disruption of these molecular interactions prevents transmigration of mononuclear leukocytes across the endothelium into inflamed parenchymal tissue. A further mechanism of action of natalizumab may be to suppress ongoing inflammatory reactions in diseased tissues by inhibiting the interaction of α4-expressing leukocytes with their ligands in the extracellular matrix and on parenchymal cells. As such, natalizumab may act to suppress inflammatory activity present at the disease site, and inhibit further recruitment of immune cells into inflamed tissues. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils. Specifically, natalizumab binds to the α4β1 integrin, blocking the interaction with its cognate receptor, vascular cell adhesion molecule-1 (VCAM-1), and ligands osteopontin, and an alternatively spliced domain of fibronectin, connecting segment-1 (CS-1). |
| Original license holder | Biogen Netherlands B.V. |
| Marketing authorisation numbers | EU/1/06/346/001 |
| Marketing authorisation holder | Biogen Netherlands B.V. Prins Mauritslaan 13 1171 LP Badhoevedorp The Netherlands |
| Name of the manufacturer of the biological active substance | Biogen Inc 5000 Davis Drive Research Triangle Park NC 27709-4627 USA FUJIFILM Diosynth Biotechnologies Denmark ApS Biotek Allé 1 DK-3400 Hillerød Denmark |
| Name and address of the manufacturer(s) responsible for batch release | FUJIFILM Diosynth Biotechnologies Denmark ApS Biotek Allé 1 DK-3400 Hillerød Denmark Biogen Netherlands B.V. Prins Mauritslaan 13 1171 LP Badhoevedorp The Netherlands |
| Max shelf life | 2 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride Polysorbate 80 (E 433) Water for injections |
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