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

janssen biotech, inc. - daratumumab (unii: 4z63yk6e0e) (daratumumab - unii:4z63yk6e0e), hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - darzalex faspro is indicated for the treatment of adult patients with multiple myeloma: - in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. - in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. - in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. - in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. - in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. - in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have receive

Israel - English - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - rituximab - concentrate for solution for infusion - rituximab 10 mg/ml - rituximab - ruxience is indicated for:non-hodgkin’s lymphoma (nhl):ruxience is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma.ruxience is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapyruxience is indicated for the treatment of patients with cd20 positive diffuse large b-cell nonhodgkin's lymphoma in combination with chop chemotherapy.ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.chronic lymphocytic leukaemia (cll):ruxience in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. rheumatoid arthritis:ruxience is indicated, in combination with methotrexate, to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response or intolerance to one or more tnf antagonist therapies.granulomatosis with polyangiitis and microscopic polyangiitis:ruxience, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (gpa) (wegener’s granulomatosis (wg)) and microscopic polyangiitis (mpa).pemphigus vulgaris:ruxience is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv).

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - daratumumab 20 mg/ml;  ;   - concentrate for infusion - 100 mg/5ml - active: daratumumab 20 mg/ml     excipient: glacial acetic acid mannitol polysorbate 20 sodium acetate trihydrate sodium chloride water for injection - darzalex is indicated for the treatment of patients: with newly diagnosed multiple myeloma: - who are eligible for autologous stem cell transplant. for use in combination with: - bortezomib, thalidomide, and dexamethasone. - who are ineligible for autologous stem cell transplant. for use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone with multiple myeloma who have received: - at least one prior therapy. for use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone. - at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent for use as: - monotherapy

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - daratumumab 20 mg/ml;  ;   - concentrate for infusion - 400 mg/20ml - active: daratumumab 20 mg/ml     excipient: glacial acetic acid mannitol polysorbate 20 sodium acetate trihydrate sodium chloride water for injection - darzalex is indicated for the treatment of patients: with newly diagnosed multiple myeloma: - who are eligible for autologous stem cell transplant. for use in combination with: - bortezomib, thalidomide, and dexamethasone. - who are ineligible for autologous stem cell transplant. for use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone with multiple myeloma who have received: - at least one prior therapy. for use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone. - at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent for use as: - monotherapy

European Union - English - 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).

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multiple myeloma - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1).as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - rituximab 10 mg/ml (murine/human monoclonal antibody);  ;  ;   - concentrate for infusion - 10 mg/ml - active: rituximab 10 mg/ml (murine/human monoclonal antibody)       excipient: citric acid hydrochloric acid polysorbate 80 sodium chloride sodium citrate dihydrate water for injection - 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.

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)

amgen europe b.v. - panitumumab - colorectal neoplasms - antineoplastic agents - vectibix is indicated for the treatment of adult patients with wild-type ras metastatic colorectal cancer (mcrc): , in first-line in combination with folfox or folfiri., in second-line in combination with folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)., as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.