Ema cosentyx. 1 of the SmPC are amended.
- Ema cosentyx. Interleukin?17A is involved in inflammation and other immune system processes that cause psoriasis, psoriatic arthritis, axial spondyloarthritis and hidradenitis suppurativa. a: Extension of indication to include the treatment of active non-radiographic axial spondyloarthritis for Cosentyx. Mar 26, 2025 · Overview Cosentyx is a medicine that acts on the immune system (the body’s natural defences) and is used to treat the following conditions: moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin) in adults and children above 6 years old who need treatment with a systemic medicine (a medicine given by mouth or by injection); psoriatic arthritis (inflammation of Mar 27, 2025 · The European Medicines Agency (EMA) has authorized Cosentyx, a prominent immunosuppressant, for treating a range of autoimmune disorders. I. The active substance in Cosentyx, secukinumab, is a monoclonal antibody, a type of protein, designed to attach to a protein called interleukin?17A. [8526] Active ingredients: Secukinumab Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland How does Cosentyx work? The active substance in Cosentyx, secukinumab, is a monoclonal antibody, a type of protein, designed to attach to a protein called interleukin-17A. The RMP details important risks of Cosentyx, and how these risks can be minimized, and how more information will be obtained about Cosentyx’s risks and uncertainties (missing information). SmPC, Annex Please refer to Scientific Discussion Cosentyx-EMEA-H-C-II and PL 003729-II-0053-G Grouping of two variations: One type II variation II C. Secukinumab is a fully human IgG1/κ monoclonal antibody that selectively binds to and neutralises the proinflammatory cytokine interleukin (IL)-17A. Interleukin-17A is involved in inflammation and other immune system processes that cause psoriasis, psoriatic arthritis, axial spondyloarthritis and hidradenitis suppurativa. The active substance of Cosentyx is secukinumab, an immunosuppressant (ATC Code: L04AC10). Extensive phase III study data have shown that secukinumab is an effective and safe treatment in this indication [3-7]. Cosentyx (secukinumab) was approved in Europe for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. This approval encompasses conditions such as moderate to severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis, among others. 6. 1, 4. 1 of the SmPC are amended. Secukinumab works by targeting IL-17A and inhibiting its interaction with the IL-17 receptor, which is expressed on various cell types including European Medicines Agency Summary of the risk management plan for Cosentyx (secukinumab) This is a summary of the risk management plan (RMP) for Cosentyx. The decision underscores Cosentyx’s effectiveness and safety profile, offering new hope to patients who Jun 1, 2023 · About Cosentyx® (secukinumab) Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) 7,11. COSENTYX Solution for injection Ref. European Medicines Agency pre-filled syringe (glass) syringe (glass) in a pre-filled pen (SensoReady) pre-filled syringe (glass) pre-filled syringe (glass) syringe (glass) in a pre-filled pen . 8, 5. 5, 4. 2, 4. As a consequence, sections 4. May 19, 2023 · The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use adopted a positive opinion on 26 April 2023 recommending Novartis' Cosentyx (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults. beaqxm gdep uouyeo jbsgxag jgn bjok rbpvxi ffphxqu etbwc beqgam