Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

janssen biologics b.v. - abciximab - solution for inj/inf - 2 mg/ml - platelet aggregation inhibitors excl. heparin

Kesatuan Eropah - Inggeris - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastic agents - rituzena is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rituzena is indicated for the treatment of previously untreated patients with stage iii iv follicular lymphoma in combination with chemotherapy.rituzena 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.rituzena 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)rituzena 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 rituzenaor patients refractory to previous rituzena plus chemotherapy.granulomatosis with polyangiitis and microscopic polyangiitisrituzena, 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 - Inggeris - 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 - Inggeris - 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

Kanada - Inggeris - Health Canada

janssen inc - abciximab - solution - 2mg - abciximab 2mg - miscellaneous therapeutic agents

Kanada - Inggeris - Health Canada

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

Kanada - Inggeris - Health Canada

hoffmann-la roche limited - rituximab - solution - 1400mg - rituximab 1400mg - antineoplastic agents

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

janssen-cilag ltd - abciximab - solution for injection - 2mg/1ml

Kanada - Inggeris - Health Canada

hoffmann-la roche limited - rituximab - solution - 1600mg - rituximab 1600mg - antineoplastic agents

Kanada - Inggeris - Health Canada

celltrion healthcare co ltd - rituximab - solution - 100mg - rituximab 100mg - antineoplastic agents