Euroopa Liit - hollandi - EMA (European Medicines Agency)

roche registration gmbh - ocrelizumab - multiple sclerose - immunosuppressiva - behandeling van volwassen patiënten met relapsing vormen van multiple sclerose (rms) met actieve ziekte gedefinieerd door klinische of beeldvormende kenmerken. de behandeling van volwassen patiënten met vroege primair progressieve multiple sclerose (ppms) in termen van de ziekte, de duur en de mate van invaliditeit, en imaging kenmerken kenmerk van inflammatoire activiteit.

Belgia - hollandi - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - temsirolimus 30 mg - concentraat en oplosmiddel voor oplossing voor infusie - 30 mg - temsirolimus 25 mg/ml - temsirolimus

Holland - hollandi - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

merck sharp & dohme b.v. waarderweg 39 2031 bn haarlem - levende, gevriesdroogde kiemen van de calmette-guerin stam 500000000 cfu/stuk - oplossing voor intravesicaal gebruik - ammonia (e 527) ; asparagine 1-water ; citroenzuur 1-water (e 330) ; dikaliumwaterstoffosfaat 0-water (e 340) ; ferriammoniumcitraat ; glycerol (e 422) ; helium (head space) (e 939) (ri) ; lactose 1-water ; magnesiumsulfaat 7-water (e 518) ; zinc formate (ri), - bcg vaccine

Holland - hollandi - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

hexal ag industriestrasse 25 d-83607 holzkirchen (duitsland) - azathioprine 25 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; hypromellose (e 464) ; lactose 1-water ; macrogolstearaat, type i ; magnesiumstearaat (e 470b) ; maÏszetmeel ; povidon (e 1201) ; silica, hydrate form unknown (e 551) ; talk (e 553 b) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; hypromellose (e 464) ; lactose 1-water ; macrogolstearaat, type i ; magnesiumstearaat (e 470b) ; maÏszetmeel ; povidon (e 1201) ; silica, hydrate form unknown (e 551) ; talk (e 553 b) ; titaandioxide (e 171), - azathioprine

Holland - hollandi - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

hexal ag industriestrasse 25 d-83607 holzkirchen (duitsland) - azathioprine 50 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; hypromellose (e 464) ; lactose 1-water ; macrogolstearaat, type i ; magnesiumstearaat (e 470b) ; maÏszetmeel ; povidon (e 1201) ; silica, hydrate form unknown (e 551) ; talk (e 553 b) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; hypromellose (e 464) ; lactose 1-water ; macrogolstearaat, type i ; magnesiumstearaat (e 470b) ; maÏszetmeel ; povidon (e 1201) ; silica, hydrate form unknown (e 551) ; talk (e 553 b) ; titaandioxide (e 171), - azathioprine

Euroopa Liit - hollandi - EMA (European Medicines Agency)

pfizer europe ma eeig - temsirolimus - carcinoma, renal cell; lymphoma, mantle-cell - antineoplastische middelen - renal-cell carcinomatorisel is geïndiceerd voor eerstelijns behandeling van volwassen patiënten met geavanceerde renal-cell carcinoma (rcc) die ten minste drie van de zes prognostische risicofactoren. mantel-cel lymphomatorisel is geïndiceerd voor de behandeling van volwassen patiënten met recidief en / of vuurvaste mantel-cel lymfoom (mcl).

Euroopa Liit - hollandi - 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.

Holland - hollandi - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

teva b.v. swensweg 5 2031 ga haarlem - azathioprine 50 mg/stuk - tablet - aardappelzetmeel ; lactose 1-water ; magnesiumstearaat (e 470b) ; povidon (e 1201) ; siliciumdioxide (e 551), - azathioprine

Holland - hollandi - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

aurobindo pharma b.v. baarnsche dijk 1 3741 ln baarn - azathioprine 50 mg/stuk - tablet - aardappelzetmeel ; lactose 1-water ; magnesiumstearaat (e 470b) ; povidon (e 1201) ; siliciumdioxide (e 551), - azathioprine

Holland - hollandi - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

aspen pharma trading limited 3016 lake drive, citywest business campus dublin 24 (ierland) - azathioprine 25 mg/stuk - filmomhulde tablet - hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; polyethyleenglycol (e 1521) ; starch, pregelatinised (not from wheat starch) ; stearinezuur (e 570) ; titaandioxide (e 171), - azathioprine