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

glaxosmithkline australia pty ltd - belimumab, quantity: 200 mg/ml - injection, solution - excipient ingredients: sodium chloride; arginine hydrochloride; histidine hydrochloride monohydrate; histidine; polysorbate 80; water for injections - benlysta is indicated for:,add-on therapy for reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (sle) with a high degree of disease activity (e.g. ana titre greater than or equal to 1:80 and/or anti-dsdna titre greater than or equal to 30 iu/ml) despite standard therapy.,treatment of active lupus nephritis in adult patients who are receiving standard therapy.,the safety and efficacy of benlysta have not been evaluated in patients with severe active central nervous system lupus.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - belimumab - solution for injection - belimumab 200 mg / 1 ml - belimumab - benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (sle) with a high degree of disease activity (e.g., positive anti-dsdna and low complement) despite standard therapy.benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

Singapore - English - HSA (Health Sciences Authority)

all eights (singapore) private limited - hematology - the sta® - staclot® drvv screen and sta® - staclot® drvv confirm kits are intended for the detection of the lupus anticoagulants (la) in plasma by the diluted russell’s viper venom test performed with analyzers of the sta® line suitable to these reagents.

European Union - English - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft rejection - immunosuppressants - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression).jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response.jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice.it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - anifrolumab - concentrate for solution for infusion - anifrolumab 150 mg/ml - anifrolumab - saphnelo is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (sle), who are receiving standard therapy.limitations of usethe efficacy of saphnelo has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. use of saphnelo is not recommended in these situations.

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

astrazeneca pty ltd - anifrolumab, quantity: 300 mg - injection, concentrated - excipient ingredients: polysorbate 80; water for injections; trehalose dihydrate; histidine hydrochloride monohydrate; histidine; lysine hydrochloride - saphnelo (anifrolumab) is indicated as add on treatment of adult patients with moderate to severe, active systemic lupus erythematosus (sle), despite standard therapy.,the safety and efficacy of saphnelo have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.

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

sandoz pty ltd - azathioprine, quantity: 25 mg - tablet, film coated - excipient ingredients: purified talc; lactose monohydrate; magnesium stearate; maize starch; povidone; colloidal anhydrous silica; titanium dioxide; hypromellose; microcrystalline cellulose; peg-8 stearate - immunosuppressant antimetabolite: either alone, or more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with higher dosage and prolonged usage of corticosteroids. azathioprine, in combination with cortocosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis/polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic ana

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

allergy laboratories, inc. - apple (unii: b423vgh5s9) (apple - unii:b423vgh5s9) - apple 1 g in 20 ml - immunotherapy using allergenic extracts is indicated for use in patients with severe allergy symptoms (hay fever, rhinitis, etc.) to pollens, molds, insects, animal danders and various other allergens. immunotherapy is intended for patients whose symptoms are not satisfactorily controlled by avoidance of the offending allergen or by the use of symptomatic medications. treatment uses only those specific allergens that the patient is sensitive to based on diagnostic tests and medical history. it is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing. there are no known absolute contraindications to diagnostic testing or hyposensitization with allergen immunotherapy.  patients with cardiovascular disease or pulmonary disease such as symptomatic asthma, and/or who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. these patients may also be more refractory to the

New Zealand - English - Medsafe (Medicines Safety Authority)

neon healthcare limited - phenelzine sulfate 25.83mg equivalent to phenelzine 15 mg - film coated tablet - 15 mg - active: phenelzine sulfate 25.83mg equivalent to phenelzine 15 mg excipient: magnesium stearate maize starch mannitol opadry red 20a25096 povidone - for the treatment of major depression. phenelzine sulfate should rarely be the first antidepressant medicine used. rather it is more suitable for use with patients who have failed to respond to the medicines more commonly used for these conditions

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

omega pharma ltd - oral capsule