Adtralza
tralokinumab
Table of contents
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.
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Adtralza : EPAR - Medicine overview (PDF/111.49 KB)
First published: 22/06/2021
Last updated: 25/11/2022
EMA/249552/2021 -
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Adtralza : EPAR - Risk-management-plan summary (PDF/2.28 MB)
First published: 22/06/2021
Authorisation details
Product details | |
---|---|
Name |
Adtralza
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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 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 | |
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Marketing-authorisation holder |
LEO Pharma A/S
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Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
17/06/2021
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Contact address |
Industriparken 55 |
Product information
20/10/2022 Adtralza - EMEA/H/C/005255 - II/0001
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.