Skyrizi
risankizumab
Table of contents
Overview
Skyrizi is a medicine used to treat plaque psoriasis, a disease causing red, scaly patches on the skin. It is used in adults with moderate to severe disease and who require systemic treatment (treatment with medicines given by mouth or by injection).
Skyrizi is also used to treat adults with psoriatic arthritis, a disease that causes psoriasis and inflammation of the joints. It is used alone or with another medicine, methotrexate, when treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or causes unacceptable side effects. DMARDs are medicines, such as methotrexate, that slow down worsening of the disease.
Skyrizi contains the active substance risankizumab.
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List item
Skyrizi : EPAR - Medicine overview (PDF/121.75 KB)
First published: 26/06/2019
Last updated: 04/01/2022
EMA/608128/2021 -
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List item
Skyrizi : EPAR - Risk-management-plan summary (PDF/59.47 KB)
First published: 26/06/2019
Last updated: 04/01/2022
Authorisation details
Product details | |
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Name |
Skyrizi
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Agency product number |
EMEA/H/C/004759
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Active substance |
Risankizumab
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International non-proprietary name (INN) or common name |
risankizumab
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
L04AC18
|
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 |
AbbVie Deutschland GmbH & Co. KG
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Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
26/04/2019
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Contact address |
Knollstrasse 50 |
Product information
27/01/2022 Skyrizi - EMEA/H/C/004759 - P46-008
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
- Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Psoriatic Arthritis
- Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).