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BAVENCIO Concentrate for solution (2018)

Active ingredients: Avelumab

Product Name and Form

Bavencio 20 mg/mL concentrate for solution for infusion.

Pharmaceutical form

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.

Chemical substance
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
Glacial acetic acid
Polysorbate 20
Sodium hydroxide
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.

Marketing authorization holder
Authorization dates

Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands

Date of first authorisation: 18 September 2017

Marketing authorization number:

EU/1/17/1214/001