Taltz
ixekizumab
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Taltz. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Taltz.
For practical information about using Taltz, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Taltz : EPAR - Summary for the public (PDF/81.44 KB)
First published: 02/05/2016
Last updated: 02/05/2016
EMA/171915/2016 -
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List item
Taltz : EPAR - Risk-management-plan summary (PDF/97.27 KB)
First published: 11/06/2020
Last updated: 07/07/2020
Authorisation details
Product details | |
---|---|
Name |
Taltz
|
Agency product number |
EMEA/H/C/003943
|
Active substance |
ixekizumab
|
International non-proprietary name (INN) or common name |
ixekizumab
|
Therapeutic area (MeSH) |
Psoriasis
|
Anatomical therapeutic chemical (ATC) code |
L04AC
|
Publication details | |
---|---|
Marketing-authorisation holder |
Eli Lilly and Company (Ireland) Limited
|
Revision |
17
|
Date of issue of marketing authorisation valid throughout the European Union |
25/04/2016
|
Contact address |
Dunderrow |
Product information
12/01/2023 Taltz - EMEA/H/C/003943 - II/0046
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
Immunosuppressants
Therapeutic indication
Plaque psoriasis
Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Psoriatic arthritis
Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.