Opzelura - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

ruxolitinib

Opinion

On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Opzelura. The marketing authorisation holder for this medicinal product is Incyte Biosciences Distribution B.V.

The CHMP adopted a new indication as follows:

Vitiligo

Opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Atopic dermatitis

Opzelura is indicated for the treatment of moderate atopic dermatitis in adult patients for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold.

CHMP post-authorisation summary of positive opinion for Opzelura (VR-0000313318)

Adopted Reference Number: EMADOC-1700519818-3086715

Key facts

• Name of medicine:
  Opzelura
• EMA product number:
  EMEA/H/C/005843
• Active substance:
  ruxolitinib phosphate
• International non-proprietary name (INN) or common name:
  ruxolitinib
• Therapeutic area (MeSH):
  Vitiligo
• Anatomical therapeutical chemical (ATC) code:
  D11AH
• Marketing authorisation holder:
  Incyte Biosciences Distribution B.V.
• Date of opinion:
  25/06/2026
• Status:
  Positive