Opzelura
ruxolitinib
Table of contents
Overview
Opzelura is a medicine used for treating non-segmental vitiligo, a disease that causes patches of skin to lose colour on both sides of the body. In patients with vitiligo, the immune system (the body’s natural defences) attacks melanocytes (the skin cells that make pigment), causing patches of pale pink or white skin (depigmentation). Opzelura is used in adults and adolescents from 12 years of age with non-segmental vitiligo that also affects the face.
Opzelura contains the active substance ruxolitinib.
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Opzelura : EPAR - Medicine overview (PDF/119.97 KB)
First published: 20/04/2023
EMA/100444/2023 -
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Opzelura : EPAR - Risk management plan summary (PDF/180.77 KB)
First published: 20/04/2023
Authorisation details
Product details | |
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Name |
Opzelura
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Agency product number |
EMEA/H/C/005843
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Active substance |
ruxolitinib phosphate
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International non-proprietary name (INN) or common name |
ruxolitinib
|
Therapeutic area (MeSH) |
Vitiligo
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Anatomical therapeutic chemical (ATC) code |
D11AH
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Publication details | |
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Marketing-authorisation holder |
Incyte Biosciences Distribution B.V.
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Date of issue of marketing authorisation valid throughout the European Union |
19/04/2023
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Contact address |
Paasheuvelweg 25 |
Product information
19/04/2023 Opzelura - EMEA/H/C/005843 -
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
Other dermatological preparations
Therapeutic indication
Opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.