European Union - English - EMA (European Medicines Agency)

roche registration gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents - mabthera is indicated in adults for the following indications:non‑hodgkin’s lymphoma (nhl)mabthera is indicated for the treatment of previously untreated adult patients with stage iii‑iv follicular lymphoma in combination with chemotherapy.mabthera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.mabthera monotherapy is indicated for treatment of adult patients with stage iii‑iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.mabthera is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non‑hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.mabthera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months  to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll).chronic lymphocytic leukaemia (cll)mabthera 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 mabthera or patients refractory to previous mabthera plus chemotherapy.rheumatoid arthritismabthera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease‑modifying anti‑rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies.mabthera has been shown to reduce the rate of progression of joint damage as measured by x‑ray and to improve physical function, when given in combination with methotrexate.granulomatosis with polyangiitis and microscopic polyangiitismabthera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa).mabthera, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa.pemphigus vulgarismabthera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; wegener granulomatosis; leukemia, lymphocytic, chronic, b-cell; microscopic polyangiitis - antineoplastic agents - truxima is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)truxima is indicated for the treatment of previously untreated patients with stage iii iv follicular lymphoma in combination with chemotherapy.truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.truxima 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.truxima 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)truxima 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 truxima or patients refractory to previous truxima plus chemotherapy.rheumatoid arthritistruxima in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease modifying anti rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies.truxima has been shown to reduce the rate of progression of joint damage as measured by x ray and to improve physical function, when given in combination with methotrexate.granulomatosis with polyangiitis and microscopic polyangiitistruxima, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa).pemphigus vulgaristruxima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

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).

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

roche products ltd - rituximab - solution for infusion - 10mg/1ml

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

roche products ltd - rituximab - solution for infusion - 10mg/1ml

Canada - English - Health Canada

pfizer canada ulc - rituximab - solution - 10mg - rituximab 10mg - antineoplastic agents

Canada - English - Health Canada

amgen canada inc - rituximab - solution - 10mg - rituximab 10mg - antineoplastic agents

Canada - English - Health Canada

sandoz canada incorporated - rituximab - solution - 10mg - rituximab 10mg - antineoplastic agents

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

sanof-aventis u.s. llc - isatuximab (unii: r30772kcu0) (isatuximab - unii:r30772kcu0) - sarclisa is indicated: - in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor. - in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. sarclisa is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients [see warnings and precautions (5.1)] . risk summary sarclisa can cause fetal harm when administered to a pregnant woman. the assessment of isatuximab-irfc-associated risks is based on the mechanism of action and data from target antigen cd38 knockout animal models (see data). there are no available data on sarclisa use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction toxicity studies hav

Israel - English - Ministry of Health

j-c health care ltd - itraconazole - solution - itraconazole 10 mg/ml - itraconazole - itraconazole - sporanox oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. prevention of fungal infection during neutropenia of immunodeficient patients.