Skyrizi
risankizumab
Table of contents
Overview
Skyrizi is a medicine used to treat adults with:
- moderate-to-severe plaque psoriasis (a disease causing red, scaly patches on the skin) who require systemic treatment (treatment with medicines given by mouth or by injection);
- active psoriatic arthritis (a disease that causes psoriasis and inflammation of the joints) 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;
- moderate-to-severe Crohn’s disease (a disease causing inflammation of the digestive tract) when conventional or biological treatments do not work well enough or cause unacceptable side effects.
When used for psoriatic arthritis, Skyrizi can be given alone or with another medicine, methotrexate.
Skyrizi contains the active substance risankizumab.
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List item
Skyrizi : EPAR - Medicine overview (PDF/115.87 KB)
First published: 26/06/2019
Last updated: 08/12/2022
EMA/804315/2022 -
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List item
Skyrizi : EPAR - Risk-management-plan summary (PDF/95.31 KB)
First published: 26/06/2019
Last updated: 08/12/2022
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 |
16
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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
25/08/2023 Skyrizi - EMEA/H/C/004759 - IB/0041/G
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
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).
Crohn's disease
Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
Assessment history
News
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16/09/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 October 202115/10/2021
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01/03/2019