EVUSHELD Solution for injection Ref.[49908] Active ingredients: Tixagevimab and Cilgavimab

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden

Product name and form

EVUSHELD 150 mg + 150 mg solution for injection.

Pharmaceutical Form

Solution for injection (injection)

Clear to opalescent, colourless to slightly yellow, pH 6.0 solution.

Qualitative and quantitative composition

Each carton contains two vials:

Each vial of tixagevimab contains 150 mg of tixagevimab in 1.5 mL (100 mg/mL).

Each vial of cilgavimab contains 150 mg of cilgavimab in 1.5 mL (100 mg/mL).

Tixagevimab and cilgavimab are produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tixagevimab and Cilgavimab

Tixagevimab and cilgavimab are two recombinant human IgG1 monoclonal antibodies, with amino acid substitutions in the Fc regions, to extend antibody half-life and to reduce antibody effector function and potential risk of antibody-dependent enhancement of disease. Tixagevimab and cilgavimab can simultaneously bind to non-overlapping regions of the spike protein receptor binding domain (RBD) of SARS-CoV-2. Tixagevimab, cilgavimab and their combination bind to spike blocking its interaction with the human ACE2 receptor, resulting in a blockade of virus entry.

List of Excipients

Histidine
Histidine hydrochloride monohydrate
Sucrose
Polysorbate 80
Water for injections

Pack sizes and marketing

Tixagevimab vial: 1.5 mL of solution for injection in a clear glass vial closed by a chlorobutyl elastomeric stopper sealed with a dark-grey aluminium flip-off top.

Cilgavimab vial: 1.5 mL of solution for injection in a clear glass vial closed by a chlorobutyl elastomeric stopper sealed with a white aluminium flip-off top.

Pack size: Each carton contains 2 vials: 1 vial of tixagevimab and 1 vial of cilgavimab.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/22/1651/001

Drugs

Drug Countries
EVUSHELD Austria, Australia, Canada, Estonia, Ireland, Japan, Lithuania, Poland, Romania, United States

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