South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

fresenius kabi south africa (pty) ltd - infusion (parenteral) - see ingredients - each 250 ml emulsion contains : glycerol 6,25 g lecithin 1,5 g soya oil 25 g

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

sphere healthcare pty ltd - equisetum arvense, quantity: 50 mg (equivalent: equisetum arvense, qty 250 mg); evening primrose oil, quantity: 200 mg (equivalent: gamma-linolenic acid, qty 20 mg); natural fish oil, quantity: 100 mg (equivalent: eicosapentaenoic acid, qty 18 mg; equivalent: docosahexaenoic acid, qty 12 mg); d-alpha-tocopherol, quantity: 20.1 mg (equivalent: d-alpha-tocopherol, qty 30 iu); pyridoxine hydrochloride, quantity: 5 mg (equivalent: pyridoxine, qty 4.11 mg); biotin, quantity: 75 microgram; betacarotene, quantity: 3 mg; retinol palmitate, quantity: 1.3875 mg; aminobenzoic acid, quantity: 5 mg; calcium ascorbate dihydrate, quantity: 36.5 mg (equivalent: ascorbic acid, qty 30 mg); calcium carbonate, quantity: 100 mg (equivalent: calcium, qty 40 mg); selenomethionine, quantity: 125 microgram (equivalent: selenium, qty 50 microgram); zinc monomethionine sulfate, quantity: 37.5 mg (equivalent: zinc, qty 7.5 mg); dried fish, quantity: 125 mg - capsule, soft - excipient ingredients: lecithin; yellow beeswax; soya oil; colloidal anhydrous silica; gelatin; glycerol; purified water; maltodextrin; colour; dl-alpha-tocopherol; arachis oil - nutritional supplement

Canada - English - Health Canada

westwood-squibb, division of bristol-myers squibb canada inc. - aminobenzoic acid; padimate o; oxybenzone - lotion - 5%; 5%; 3% - aminobenzoic acid 5%; padimate o 5%; oxybenzone 3% - sunscreen agents

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

morningside healthcare ltd - methotrexate - oral tablet - 10mg

Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - methotrexate - solution for infusion or injection - methotrexate 25 mg/ml - antineoplastic agents

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis b surface antigen, poliovirus (inactivated) (type-1 (mahoney strain), type-2 (mef-1 strain), type-3 (saukett strain)), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines - infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and disease caused by haemophilus influenzae type-b.

European Union - English - EMA (European Medicines Agency)

nordic group b.v. - methotrexate - arthritis, psoriatic, psoriasis, arthritis, juvenile rheumatoid, arthritis, rheumatoid - antineoplastic agents, - nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (jia), when the response to nonsteroidal anti-inflammatory drugs (nsaids) has been inadequate,severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet a (puva), and retinoids, and severe psoriatic arthritis in adult patients.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - methotrexate - solution for injection - methotrexate 50 mg/ml - methotrexate - methotrexate - psoriasis in adult patients :because of the high risk attending its use, methotrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. rheumatoid arthritis: methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well estabished according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose nsaids and usually a trial of at least one or more disease-modifying antirheumatic drugs.juvenile idiopathic arthritis:treatment of polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-inflammatory drugs (nsaids) has been inadequatecrohn’s disease: mild to moderate crohn's disease either alone or in combination with corticosteroids in adult patients refractory or intolerant to thiopurines.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - methotrexate - solution for injection - methotrexate 50 mg/ml - methotrexate - methotrexate - psoriasis in adult patients :because of the high risk attending its use, methotrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. rheumatoid arthritis: methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well estabished according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose nsaids and usually a trial of at least one or more disease-modifying antirheumatic drugs.juvenile idiopathic arthritis:treatment of polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-inflammatory drugs (nsaids) has been inadequatecrohn’s disease: mild to moderate crohn's disease either alone or in combination with corticosteroids in adult patients refractory or intolerant to thiopurines.

Israel - English - Ministry of Health

tzamal bio-pharma ltd - methotrexate - solution for injection - methotrexate 50 mg/ml - methotrexate - methotrexate - psoriasis in adult patients :because of the high risk attending its use, methotrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. rheumatoid arthritis: methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well estabished according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose nsaids and usually a trial of at least one or more disease-modifying antirheumatic drugs.juvenile idiopathic arthritis:treatment of polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-inflammatory drugs (nsaids) has been inadequatecrohn’s disease: mild to moderate crohn's disease either alone or in combination with corticosteroids in adult patients refractory or intolerant to thiopurines.