Bimzelx
bimekizumab
Table of contents
Overview
Bimzelx is a medicine used to treat plaque psoriasis, a disease that causes red, scaly patches on the skin. It is used in adults with moderate to severe disease who need systemic treatment (treatment with medicines affecting the whole body).
Bimzelx contains the active substance bimekizumab.
-
List item
Bimzelx : EPAR - Medicine overview (PDF/119.73 KB)
First published: 24/08/2021
EMA/432519/2021 -
-
List item
Bimzelx : EPAR - Risk-management-plan summary (PDF/185.04 KB)
First published: 24/08/2021
Authorisation details
Product details | |
---|---|
Name |
Bimzelx
|
Agency product number |
EMEA/H/C/005316
|
Active substance |
Bimekizumab
|
International non-proprietary name (INN) or common name |
bimekizumab
|
Therapeutic area (MeSH) |
Psoriasis
|
Anatomical therapeutic chemical (ATC) code |
L04AC
|
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 | |
---|---|
Marketing-authorisation holder |
UCB Pharma S.A.
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
20/08/2021
|
Contact address |
UCB Pharma S.A. |
Product information
05/12/2022 Bimzelx - EMEA/H/C/005316 - IB/0013
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
Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.