Spevigo

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spesolimab

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

Overview

Spevigo is a medicine that acts on the immune system. It is used in adults to treat flare-ups (recurrence or worsening) of generalised pustular psoriasis, an inflammatory skin disease causing pustules (pus-filled lesions) to appear over large areas of skin.

Spevigo contains the active substance spesolimab.

This EPAR was last updated on 08/02/2023

Authorisation details

Product details
Name
Spevigo
Agency product number
EMEA/H/C/005874
Active substance
Spesolimab
International non-proprietary name (INN) or common name
spesolimab
Therapeutic area (MeSH)
Psoriasis
Anatomical therapeutic chemical (ATC) code
L04AC22
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.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Date of issue of marketing authorisation valid throughout the European Union
09/12/2022
Contact address

Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Product information

Spevigo - EMEA/H/C/005874 -

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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

Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.

Assessment history

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