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

mylan b.v. dieselweg 25 3752 lb bunschoten - leflunomide 100 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; hypromellose (e 464) ; lactose 1-water ; macrogol 4000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hypromellose (e 464) ; lactose 1-water ; macrogol 4000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171), - leflunomide

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(i)) ; 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), 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)

merck europe b.v. - avelumab - neuro-endocriene tumoren - andere antineoplastische middelen, monoklonale antilichamen - bavencio is geïndiceerd als monotherapie voor de behandeling van volwassen patiënten met gemetastaseerd merkelcelcarcinoom (mcc). bavencio in combinatie met axitinib is geïndiceerd voor eerstelijns behandeling van volwassen patiënten met gevorderd niercelcarcinoom (rcc). bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc) who are progression-free following platinum‑based chemotherapy.

Europese Unie - Nederlands - EMA (European Medicines Agency)

takeda pharma a/s - darvadstrocel - anale fistels - immunosuppressiva - alofisel is geïndiceerd voor de behandeling van complexe perianale fistels bij volwassen patiënten met niet-actief/licht actieve luminale ziekte van crohn, bij fistels hebben aangetoond dat een onvoldoende respons op ten minste één van conventionele of biologische therapie. alofisel gebruikt zou moeten worden na de behandeling van fistels.

Europese Unie - Nederlands - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft rejection - immunosuppressiva - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pi pharma sa-nv - mercaptopurine 50 mg - tablet - mercaptopurine

Europese Unie - Nederlands - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - spesolimab - psoriasis - immunosuppressiva - spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (gpp) as monotherapy.