European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents - blitzima is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)blitzima is indicated for the treatment of previously untreated patients with stage iii-iv follicular lymphoma in combination with chemotherapy.blitzima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.blitzima monotherapy is indicated for treatment of patients with stage iii-iv follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.blitzima is indicated for the treatment of patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.chronic lymphocytic leukaemia (cll)blitzima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory cll. only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including blitzima or patients refractory to previous blitzima plus chemotherapy.

European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; wegener granulomatosis - antineoplastic agents - ritemvia is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl) ritemvia is indicated for the treatment of previously untreated patients with stage iii, iv follicular lymphoma in combination with chemotherapy.ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.ritemvia monotherapy is indicated for treatment of patients with stage iii, iv follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy.ritemvia is indicated for the treatment of patients with cd20 positive diffuse large b cell non hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.granulomatosis with polyangiitis and microscopic polyangiitis.ritemvia, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa).

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - rituximab 120 mg/ml;   - solution for injection - 1400mg/11.7ml - active: rituximab 120 mg/ml   excipient: histidine histidine hydrochloride hyaluronidase methionine polysorbate 80 trehalose dihydrate water for injection - non-hodgkin's lymphoma mabthera is indicated for the treatment of patients with: · cd20 positive, previously untreated low-grade or follicular, b-cell non-hodgkin's lymphoma in combination with chemotherapy, · cd20 positive, relapsed or chemoresistant low-grade or follicular, b-cell non-hodgkin's lymphoma, · cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. mabthera is indicated for maintenance treatment of patients with cd20 positive, low grade or follicular, b-cell non-hodgkin's lymphoma.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - rituximab 1600mg;   - solution for injection - 1600mg/13.4ml - active: rituximab 1600mg   excipient: histidine histidine hydrochloride methionine polysorbate 80 trehalose dihydrate vorhyaluronidase alfa water for injection - mabthera sc 1600 mg in combination with chemotherapy is indicated for the treatment of patients with chronic lymphocytic leukaemia

Kenya - English - Pharmacy and Poisons Board

f. hoffman-la roche ltd capitol hill towerscathedral road. p.o. box - rituximab - injection - rituximab - other antineoplastic agents: monoclonal antibodies

Kenya - English - Pharmacy and Poisons Board

f. hoffman-la roche ltd capitol hill towerscathedral road. p.o. box - rituximab - injection - rituximab 500mg - other antineoplastic agents: monoclonal antibodies

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

acrotech biopharma inc - ibritumomab tiuxetan (unii: 4q52c550xk) (ibritumomab tiuxetan - unii:4q52c550xk) - zevalin is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular b-cell non-hodgkin's lymphoma (nhl). zevalin is indicated for the treatment of previously untreated follicular nhl in adult patients who achieve a partial or complete response to first-line chemotherapy. none. risk summary based on its radioactivity, y-90 zevalin may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]  . immunoglobulins are known to cross the placenta. there are no available data on zevalin use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. advise women of childbearing potential to use adequate contraception for a minimum of twelve months. inform women who become pregnant while receiving zevalin of the potential fetal risks. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other

Canada - English - Health Canada

hoffmann-la roche limited - rituximab - solution - 10mg - rituximab 10mg - antineoplastic agents

Canada - English - Health Canada

glaxosmithkline inc - tositumomab - solution - 14mg - tositumomab 14mg - antineoplastic agents

Canada - English - Health Canada

janssen inc - daratumumab - solution - 400mg - daratumumab 400mg - antineoplastic agents