BEYFORTUS Solution for injection Ref.[50357] Active ingredients: Nirsevimab

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

Product name and form

Beyfortus 50 mg solution for injection in pre-filled syringe.

Beyfortus 100 mg solution for injection in pre-filled syringe.

Pharmaceutical Form
Solution for injection (injection). Clear to opalescent, colourless to yellow, pH 6.0 solution.

Qualitative and quantitative composition

Beyfortus 50 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 50 mg of nirsevimab in 0.5 mL (100 mg/mL).

Beyfortus 100 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 100 mg of nirsevimab in 1 mL (100 mg/mL).

Nirsevimab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Nirsevimab	Nirsevimab is a recombinant neutralising human IgG1ĸ long-acting monoclonal antibody to the prefusion conformation of the RSV F protein which has been modified with a triple amino acid substitution (YTE) in the Fc region to extend serum half-life. Nirsevimab inhibits the essential membrane fusion step in the viral entry process, neutralising the virus and blocking cell-to-cell fusion.

List of Excipients
L-histidine L-histidine hydrochloride L-arginine hydrochloride Sucrose Polysorbate 80 Water for injections

Pack sizes and marketing

Siliconised Luer lock Type I glass pre-filled syringe with a FluroTec-coated plunger stopper.

Each pre-filled syringe contains 0.5 mL or 1 mL solution.

Pack sizes:

1 or 5 pre-filled syringe(s) without needles.
1 pre-filled syringe packaged with two separate needles of different sizes.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/22/1689/001 50 mg, 1 single-use pre-filled syringe
EU/1/22/1689/002 50 mg, 1 single-use pre-filled syringe with needles
EU/1/22/1689/003 50 mg, 5 single-use pre-filled syringe
EU/1/22/1689/004 100 mg, 1 single-use pre-filled syringe
EU/1/22/1689/005 100 mg, 1 single-use pre-filled syringe with needles
EU/1/22/1689/006 100 mg, 5 single-use pre-filled syringe

Drugs

Drug	Countries
BEYFORTUS	Austria, Canada, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Romania, United States

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