Spevigo
spesolimab
Table of contents
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.
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List item
Spevigo : EPAR - Medicine Overview (PDF/118.18 KB)
First published: 08/02/2023
EMA/849592/2022 -
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List item
Spevigo : EPAR - Risk Management Plan (PDF/1.75 MB)
First published: 08/02/2023
Authorisation details
Product details | |
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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 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 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 | |
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Marketing-authorisation holder |
Boehringer Ingelheim International GmbH
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Date of issue of marketing authorisation valid throughout the European Union |
09/12/2022
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Contact address |
Binger Strasse 173 |
Product information
Spevigo - EMEA/H/C/005874 -
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
Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.