United States - English - NLM (National Library of Medicine)

e.r. squibb & sons, l.l.c. - belatacept (unii: e3b2gi648a) (belatacept - unii:e3b2gi648a) - belatacept 250 mg - nulojix® (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. nulojix is to be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. use nulojix only in patients who are ebv seropositive [see contraindications (4) and warnings and precautions (5.1)] . use of nulojix for the prophylaxis of organ rejection in transplanted organs other than kidney has not been established [see warnings and precautions (5.6)] . nulojix is contraindicated in transplant recipients who are epstein-barr virus (ebv) seronegative or with unknown ebv serostatus due to the risk of post-transplant lymphoproliferative disorder (ptld), predominantly involving the central nervous system (cns) [see boxed warning and warnings and precautions (5.1)] . to monitor maternal-fetal outcomes of pregnant women who have received immunosuppressants including nulojix or whose partners have received nulojix, healthcare providers are strongly encouraged to regis

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - belatacept - graft rejection; kidney transplantation - immunosuppressants - nulojix, in combination with corticosteroids and a mycophenolic acid (mpa), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant. 

Australia - English - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - belatacept, quantity: 250 mg - injection, intravenous infusion - excipient ingredients: water for injections; hydrochloric acid; monobasic sodium phosphate; sucrose; nitrogen; sodium hydroxide; sodium chloride - nulojix (belatacept) is indicated for prophylaxis of organ rejection in adults receiving a renal transplant. nulojix is to be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

bristol-myers squibb pharmaceuticals ltd - belatacept - powder for solution for infusion - 250mg

Israel - English - Ministry of Health

bristol-myers squibb (israel) limited - belatacept 25 mg/ml - powder for concentrate for infusion - belatacept - nulojix, in combination with corticosteroids and mycophenolic acid (mpa), is indicated for prophylaxis of graft rejection in adults receiving a renal transplant. it is recommended to add an interleukin (il)-2 receptor antagonist for induction therapy to this belatacept-based regimen

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

bristol-myers squibb - belatacept - lyophilisate for solution for injection - 250 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - mycophenolate mofetil 250mg;   - capsule - 250 mg - active: mycophenolate mofetil 250mg   excipient: croscarmellose sodium gelatin magnesium stearate povidone pregelatinised maize starch - cellcept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. cellcept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - mycophenolate mofetil 500mg (as 542 mg of the hydrochloride salt);   - powder for infusion - 500 mg - active: mycophenolate mofetil 500mg (as 542 mg of the hydrochloride salt)   excipient: citric acid polysorbate 80 sodium chloride - cellcept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. cellcept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - mycophenolate mofetil 200 mg/ml;   - powder for oral suspension - 200 mg/ml - active: mycophenolate mofetil 200 mg/ml   excipient: aspartame citric acid colloidal silicon dioxide fruit mix flavour 274869 lecithin methyl hydroxybenzoate sodium citrate dihydrate sorbitol xanthan gum - cellcept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. cellcept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - mycophenolate mofetil 500mg;   - tablet - 500 mg - active: mycophenolate mofetil 500mg   excipient: croscarmellose sodium magnesium stearate microcrystalline cellulose opadry lavender y-5-10272-a povidone - cellcept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. cellcept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.