BAVENCIO Concentrate for solution (2018)
Active ingredients: Avelumab
Product Name and Form
Bavencio 20 mg/mL concentrate for solution for infusion.
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 270 and 330 mOsm/kg.
Qualitative and Quantitative Composition
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.
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.
Glacial acetic acid
Water for injections
Pack sizes and Marketing
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
Date of first authorisation: 18 September 2017