Skyrizi

RSS

risankizumab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 14/03/2022

Authorisation details

Product details
Name
Skyrizi
Agency product number
EMEA/H/C/004759
Active substance
Risankizumab
International non-proprietary name (INN) or common name
risankizumab
Therapeutic area (MeSH)
  • Psoriasis
  • Arthritis, Psoriatic
Anatomical therapeutic chemical (ATC) code
L04AC18
Additional monitoringAdditional 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
Marketing-authorisation holder
AbbVie Deutschland GmbH & Co. KG
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
26/04/2019
Contact address

Knollstrasse 50
67061 Ludwigshafen am Rhein
Germany

Product information

27/01/2022 Skyrizi - EMEA/H/C/004759 - P46-008

Product information documents contain:

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).

Assessment history

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