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 contains the active substance risankizumab.
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Skyrizi : EPAR - Medicine overview (PDF/69.76 KB)
First published: 26/06/2019
EMA/156705/2019 -
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Skyrizi : EPAR - Risk-management-plan summary (PDF/79.22 KB)
First published: 26/06/2019
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) |
Psoriasis
|
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 |
4
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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
15/10/2020 Skyrizi - EMEA/H/C/004759 - II/0010/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.