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

medac gmbh - mycobacterium tuberculosi (= bcg) (= bacillus calmette-guerin) 2 10*8 cfu/dosis - 3 10*9 cfu/dosis - poeder en oplosmiddel voor suspensie voor intravesicaal gebruik - tuberculine (bcg) - bcg vaccine

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

medac gesellschaft für klinische spezialpräparate mbh theaterstrasse 6 d-22880 wedel (duitsland) - levende, gevriesdroogde kiemen van de calmette-guerin stam 200000000 - 3000000000 e/flacon - poeder voor blaasspoeling - glucose 0-water ; natriumchloride ; polygeline ; polysorbaat 80 (e 433) ; water, gezuiverd, - bcg vaccine

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

msd belgium bv-srl - mycobacterium tuberculosi (= bcg) (= bacillus calmette-guerin) 2 10*8 cfu - 8 10*8 cfu - poeder voor suspensie voor intravesicaal gebruik - tuberculine (bcg) - bcg vaccine

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

bmodesto b.v. minervaweg 2 8239 dl lelystad - levende, gevriesdroogde kiemen van de calmette-guerin stam - poeder voor blaasspoeling - glucose 0-water ; natriumchloride ; polygeline ; polysorbaat 80 (e 433) ; water voor injectie

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

aj vaccines a/s 5, artillerivej dk-2300 kopenhagen s (denemarken) - levende, gevriesdroogde kiemen van de calmette-guerin stam 0,75 mg/flacon - poeder en oplosmiddel voor oplossing voor injectie - asparagine 1-water ; citroenzuur 1-water (e 330) ; dikaliumwaterstoffosfaat 0-water (e 340) ; ferriammoniumcitraat ; glycerol (e 422) ; magnesiumsulfaat 7-water (e 518) ; natriumglutamaat 1-water (e 621) ; stikstof (head space) (e 941) ; water voor injectie, asparagine 1-water ; citroenzuur 1-water (e 330) ; dikaliumwaterstoffosfaat 0-water (e 340) ; ferriammoniumcitraat ; glycerol (e 422) ; magnesiumsulfaat 7-water (e 518) ; natriumglutamaat 1-water (e 621) ; stikstof (head space) (e 941) ; water, gezuiverd, - tuberculosis, live attenuated

Nederland - Nederlands - 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

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.