Omvoh - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation.
mirikizumab
Post-authorisationHuman
On 12 December 2024, 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 Omvoh. The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V.
The CHMP adopted a new strength, 200 mg solution for injection in pre-filled syringe or pre-filled pen, and a new indication as follows:
Crohn’s disease:
Omvoh is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
For information, the full indication will be as follows1:
Ulcerative colitis
Omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
Crohn’s disease:
Omvoh is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) and made available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1New text in bold, removed text as strikethrough
CHMP post-authorisation summary of positive opinion for Omvoh (X-06-G)
AdoptedReference Number: EMA/CHMP/548700/2024
English (EN) (133.41 KB - PDF)
First published: