European Commission Approves Upadacitinib for the Treatment of Adults with Moderate to Severely active Ulcerative Colitis

AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval of Upadacitinib (45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.*

This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via HPRA pharmacovigilance website www.hpra.ie . Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.