Skyrizi

RSS

risankizumab

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

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.

This EPAR was last updated on 17/01/2023

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
14
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

10/01/2023 Skyrizi - EMEA/H/C/004759 - PSUSA/00010765/202203

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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).

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

Changes since initial authorisation of medicine

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