Rinvoq - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
upadacitinib
Post-authorisationHuman
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 Rinvoq. The marketing authorisation holder for this medicinal product is Abbvie Deutschland GmbH & Co. KG.
The CHMP adopted a new indication as follows:
Alopecia areata
Rinvoq is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older (see section 5.1).
The previously authorised indications for Rinvoq remain unchanged and are described in the Summary of product characteristics (SmPC).
For information, on 25 June 2026, the CHMP also adopted a new indication for the treatment of non-segmental vitiligo in adults and adolescents 12 years and older who are candidates for systemic therapy. Further details are provided in a dedicated summary of opinion available on the EMA website.
Detailed recommendations for the use of this product will be described in the updated 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.
CHMP post-authorisation summary of positive opinion for Rinvoq (VR-0000312506)
Adopted
Reference Number: EMADOC-1700519818-3215454
English (EN) (117.69 KB - PDF)
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