Adtralza

RSS

tralokinumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Adtralza is a medicine for treating adults and children above 12 years of age with moderate to severe atopic dermatitis (also known as eczema, when the skin is itchy, red and dry). It is used in patients for whom treatment applied directly to the skin cannot be used or is not sufficient.

Adtralza contains the active substance tralokinumab.

This EPAR was last updated on 14/12/2022

Authorisation details

Product details
Name
Adtralza
Agency product number
EMEA/H/C/005255
Active substance
Tralokinumab
International non-proprietary name (INN) or common name
tralokinumab
Therapeutic area (MeSH)
Dermatitis, Atopic
Anatomical therapeutic chemical (ATC) code
D11
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
LEO Pharma A/S
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
17/06/2021
Contact address

Industriparken 55
2750 Ballerup
Denmark

Product information

20/10/2022 Adtralza - EMEA/H/C/005255 - II/0001

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other dermatological preparations

Therapeutic indication

Adtralza is indicated for the treatment of moderate to severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.

Assessment history

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