Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

mylan b.v. dieselweg 25 3752 lb bunschoten - leflunomide 20 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171), - leflunomide

Europese Unie - Nederlands - EMA (European Medicines Agency)

gilead sciences ireland uc, galapagos nv - filgotinib maleate - artritis, reumatoïde - immunosuppressiva - rheumatoid arthritisjyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca 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 agent.