Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
Vyloy 100 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. White to off-white lyophilised powder. |
One vial of powder for concentrate for solution for infusion contains 100 mg zolbetuximab.
After reconstitution, each mL of solution contains 20 mg of zolbetuximab.
Zolbetuximab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Excipient with known effect:
Each mL of concentrate contains 0.21 mg of polysorbate 80.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Zolbetuximab |
Zolbetuximab is a chimeric (mouse/human IgG1) monoclonal antibody directed against the tight junction molecule CLDN18.2. Nonclinical data suggest zolbetuximab binds selectively to cell lines transfected with CLDN18.2 or those that endogenously express CLDN18.2. Zolbetuximab depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). |
| List of Excipients |
|---|
|
Arginine |
20 mL Type I glass vial with European blow-back feature, grey bromobutyl rubber stopper with ethylene tetrafluoroethylene film, and aluminum seal with a green cap.
Pack sizes: one carton containing 1 or 3 vials.
Not all pack sizes may be marketed.
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
EU/1/24/1856/001
EU/1/24/1856/002
| Drug | Countries | |
|---|---|---|
| VYLOY | Austria, Estonia, Lithuania, United Kingdom, United States |
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