Ireland - English - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - dexamethasone sodium phosphate - solution for injection/infusion - 4 milligram(s)/millilitre - glucocorticoids; dexamethasone - glucocorticoids - it e can be used for all forms of general and local glucocorticoid injection therapy and all acute conditions in which intravenous glucocorticoids may be life-saving.

Israel - English - Ministry of Health

taro pharmaceutical industries ltd - triamcinolone - tablets - triamcinolone 4 mg - triamcinolone - triamcinolone - rheumatology: - active phases of systemic vasculitis: panarteritis nodosa (in patients with concomitant positive hepatitis b serology, the duration of treatment should be restricted to two weeks), polymyalgia rheumatica (pmr), pmr with giant cell arteritis, arteritis temporalis with acute visual loss;- active phases of systemic rheumatic disease: systemic lupus erythematosus, mixed connective tissue disease;- severe progressive forms of active rheumatoid arthritis, e.g. rapidly destructive forms and/or with extra-articular manifestations;- other forms of inflammatory rheumatic arthritis, provided that the severity of symptoms requires it and non-steroidal anti-inflammatory drugs (nsaids) cannot be used:spondylarthritis (ankylosing spondylitis with involvement of peripheral joints, psoriatic arthritis, enteropathic arthropathy with high inflammatory activity);- reactive forms of arthritis;- arthritis in sarcoidosis;- severe systemic form of juvenile idiopathic arthritis (still’s disease) or with iridocyclitis refractory to topical treatment.pulmonary and respiratory tract disorders: - bronchial asthma:for the long-term treatment of severe chronic asthma (category 4) and for treatment of exacerbations in adults and children.- chronic obstructive pulmonary disease (copd):for short-term treatment (max. 14 days) of exacerbations;- upper respiratory tract disorders:for short-term treatment of severe forms of allergic rhinitis in adults after failure of all other treatment alternatives, including topical glucocorticoids.dermatology: - oral initial treatment of extensive, severe, acute skin conditions responsive to glucocorticoids, such as: allergic skin disease (e.g. acute urticaria, contact dermatitis, drug eruption), atopic eczema (acute exacerbations or extensive weeping eczema), pemphigus vulgaris.nephrology: - minimal change glomerulonephritis;- extracapillary proliferative glomerulonephritis (rapidly progressive glomerulonephritis), generally in combination with cytostatics, tapering and ending treatment in goodpasture’s syndrome; for all other forms, long-term continuation of treatment;- idiopathic retroperitoneal fibrosis.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - rituximab - concentrate for solution for infusion - rituximab 10 mg/ml - rituximab - rituximab - mabthera is indicated for the following indications: * non-hodgkin’s lymphoma (nhl)mabthera is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma.mabthera is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy mabthera is indicated for the treatment of patients with cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop chemotherapy. mabthera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. * chronic lymphocytic leukaemia (cll)mabthera 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 mabthera or patients refractory to previous mabthera plus chemotherapy.* rheumatoid arthritismabthera 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 polyangiitismabthera, 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 vulgarismabthera is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv).

Israel - English - Ministry of Health

amgen europe b.v. - denosumab - solution for injection - denosumab 60 mg / 1 ml - denosumab - denosumab - treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. in postmenopausal women prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. in men with prostate cancer receiving hormone ablation, prolia significantly reduces the risk of vertebral fractures.treatment of bone loss associated with long-term systemic glucocorticoid therapy of a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 3 months, in adult patients at high risk of fracture.

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 truxima 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; - cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia truxima is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.,rheumatoid arthritis truxima (rituximab) 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 at least one tumour necrosis factor (tnf) inhibitor therapy. truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa) truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

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 truxima 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; - cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia truxima is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.,rheumatoid arthritis truxima (rituximab) 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 at least one tumour necrosis factor (tnf) inhibitor therapy. truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa) truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

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

sandoz pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: sodium chloride; citric acid monohydrate; hydrochloric acid; water for injections; sodium hydroxide; polysorbate 80 - non-hodgkin?s lymphoma (nhl),riximyo (rituximab) 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,,? cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia (cll),riximyo (rituximab) is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia in combination with chemotherapy.,rheumatoid arthritis (ra),riximyo (rituximab) 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 at least one tumour necrosis factor (tnf) inhibitor therapy. rituximab has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa),riximyo (rituximab) in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

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

sandoz pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: water for injections; polysorbate 80; citric acid monohydrate; hydrochloric acid; sodium chloride; sodium hydroxide - non-hodgkin?s lymphoma (nhl),riximyo (rituximab) 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,,? cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia (cll),riximyo (rituximab) is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia in combination with chemotherapy.,rheumatoid arthritis (ra),riximyo (rituximab) 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 at least one tumour necrosis factor (tnf) inhibitor therapy. rituximab has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa),riximyo (rituximab) in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - rituximab - concentrate for solution for infusion - rituximab 10 mg/ml - rituximab - truxima is indicated in adults for the following indications: * non-hodgkin’s lymphoma (nhl) truxima is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma. truxima is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy. truxima is indicated for the treatment of patients with cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop chemotherapy. truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.* 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 rituximab or patients refractory to previous rituximab plus chemotherapy.* granulomatosis with polyangiitis and microscopic polyangiitistruxima, 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):truxima is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv).

Ireland - English - HPRA (Health Products Regulatory Authority)

aspen pharma trading limited - dexamethasone - tablet - 2 milligram(s) - glucocorticoids; dexamethasone