Summary of opinion: Bimzelx, 21/03/2024 Positive

On 21 March 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 Bimzelx.

Metadata
Provider: 
European Medicines AgencyEuropean Medicines Agency
URL: 
https://www.ema.europa.eu/en/medicines/human/variation/bimzelxhttps://www.ema.europa.eu/en/medicines/human/variation/bimzelx
Retrieved on: 
星期三, 四月 3, 2024
Information
Tags: 
Civil service commission, Psoriatic arthritis, Hidradenitis suppurativa, Methotrexate, Psoriasis, MRI, Magnetic resonance imaging, Inflammation, Committee, Nonsteroidal anti-inflammatory drug, Disease-modifying antirheumatic drug, HS, Medication package insert, C-reactive protein, Ankylosing spondylitis, European Commission, Marketing, CHMP, CRP, Axial spondyloarthritis
Geotags: 
EUROPEAN UNION
摘要
Key Points: 
  • On 21 March 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 Bimzelx.
  • The marketing authorisation holder for this medicinal product is UCB Pharma S.A.
  • The CHMP adopted a new indication for the treatment of hidradenitis suppurativa.
  • Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
    Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
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