ADTRALZA Solution for injection Ref.[27596] Active ingredients: Tralokinumab

Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

Product name and form

Adtralza 150 mg solution for injection in pre-filled syringe.

Pharmaceutical Form
Solution for injection (injection). Clear to opalescent, colourless to pale yellow solution, pH 5.5 and osmolarity approximately 280 mOsm/L.

Qualitative and quantitative composition

Each pre-filled syringe contains 150 mg of tralokinumab in 1 mL solution (150 mg/mL).

Tralokinumab is produced in mouse myeloma cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Tralokinumab	Tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to the type 2 cytokine interleukin-13 (IL-13) and inhibits its interaction with the IL-13 receptors. IL-13 is a major driver of human type 2 inflammatory disease, such as atopic dermatitis and inhibiting the IL-13 pathway with tralokinumab in patients decreases many of the mediators of type 2 inflammation.

List of Excipients
Sodium acetate trihydrate (E262) Acetic acid (E260) Sodium chloride Polysorbate 80 (E433) Water for injections

Pack sizes and marketing

1 mL (150 mg) solution in a siliconised type-1 clear glass pre-filled syringe with 27 gauge ½ inch thin wall stainless steel staked needle, elastomer plunger stopper extended finger flange and needle guard.

Pack size:

2 pre-filled syringes
Multipack containing 4 (2 packs of 2) pre-filled syringes
Multipack containing 12 (6 packs of 2) pre-filled syringes.

Not all pack sizes may be marketed.

Marketing authorization holder

LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark

Marketing authorization dates and numbers

EU/1/21/1554/001
EU/1/21/1554/002
EU/1/21/1554/003

Drugs

Drug	Countries
ADTRALZA	Estonia, Croatia, Ireland, Japan, Lithuania, Poland, Romania, United Kingdom

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