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

celltrion healthcare australia pty ltd - rituximab, quantity: 500 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; polysorbate 80; water for injections; sodium chloride - non-hodgkin?s lymphoma tuxella is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma , chronic lymphocytic leukaemia tuxella is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.

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

celltrion healthcare australia pty ltd - rituximab, quantity: 100 mg - injection, concentrated - excipient ingredients: polysorbate 80; water for injections; sodium chloride; sodium citrate dihydrate - non-hodgkin?s lymphoma tuxella is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma , chronic lymphocytic leukaemia tuxella is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.

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

celltrion healthcare australia pty ltd - rituximab, quantity: 100 mg - injection, concentrated - excipient ingredients: water for injections; polysorbate 80; sodium chloride; sodium citrate dihydrate - non-hodgkin?s lymphoma ritemvia is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma;

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

celltrion healthcare australia pty ltd - rituximab, quantity: 500 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; polysorbate 80; water for injections; sodium chloride - non-hodgkin?s lymphoma ritemvia is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma;

Israel - English - Ministry of Health

novartis israel ltd - rituximab - concentrate for solution for infusion - rituximab 10 mg / 1 ml - rituximab - rixathon is indicated for the following indications: * non-hodgkin’s lymphoma (nhl): rixathon is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma. rixathon is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy.rixathon is indicated for the treatment of patients with cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop chemotherapy. rixathon maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. * chronic lymphocytic leukaemia (cll): rixathon in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rixathon or patients refractory to previous rixathon plus chemotherapy.* granulomatosis with polyangiitis and microscopic polyangiitis: rixathon, 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 (pv):rixathon is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv)

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.2).,

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

sanofi-aventis australia pty ltd - isatuximab, quantity: 500 mg - injection, concentrated - excipient ingredients: water for injections; histidine hydrochloride monohydrate; sucrose; polysorbate 80; histidine - sarclisa is indicated:,? in combination with pomalidomide and dexamethasone, for the treatment of patients with multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi).,? in combination with carfilzomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

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

sanofi-aventis australia pty ltd - isatuximab, quantity: 100 mg - injection, concentrated - excipient ingredients: histidine; histidine hydrochloride monohydrate; polysorbate 80; sucrose; water for injections - sarclisa is indicated:,? in combination with pomalidomide and dexamethasone, for the treatment of patients with multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi).,? in combination with carfilzomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - ritlecitinib tosilate - alopecia areata - immunosuppressants - litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.

Canada - English - Health Canada

sanofi-aventis canada inc - anti-thymocyte globulin (rabbit) - powder for solution - 25mg - anti-thymocyte globulin (rabbit) 25mg - miscellaneous therapeutic agents