This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 20/04/2023

Authorisation details

Product details
Agency product number
Active substance
ruxolitinib phosphate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Incyte Biosciences Distribution B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

19/04/2023 Opzelura - EMEA/H/C/005843 -

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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

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.

Assessment history

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