Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Bavencio 20 mg/mL concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion (sterile concentrate). Clear, colourless to slightly yellow solution. The solution pH is in the range of 5.0 – 5.6 and the osmolality is between 285 and 350 mOsm/kg. |
Each mL of concentrate contains 20 mg of avelumab.
One vial of 10 mL contains 200 mg of avelumab.
Avelumab is a human monoclonal IgG1 antibody directed against the immunomodulatory cell surface ligand protein PD-L1 and produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Avelumab |
Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against programmed death ligand 1 (PD-L1). Avelumab binds PD-L1 and blocks the interaction between PD-L1 and the programmed death 1 (PD-1) and B7.1 receptors. This removes the suppressive effects of PD-L1 on cytotoxic CD8+ T-cells, resulting in the restoration of anti-tumour T-cell responses. |
| List of Excipients |
|---|
|
Mannitol |
10 mL of concentrate in a vial (Type I glass) with a halobutyl rubber stopper and an aluminium seal fitted with a removable plastic cap.
Pack size of 1 vial.
Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
EU/1/17/1214/001
Date of first authorisation: 18 September 2017
Date of latest renewal: 23 July 2020
| Drug | Countries | |
|---|---|---|
| BAVENCIO | Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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