Israel - English - Ministry of Health

j-c health care ltd - hydrocortisone; miconazole nitrate - cream - hydrocortisone 10 mg/g; miconazole nitrate 20 mg/g - hydrocortisone and antibiotics - hydrocortisone and antibiotics - infections of the skin caused by dermatophytes or candida species in which inflammatory symptoms are prominent.

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

viatris pty ltd - phenoxymethylpenicillin benzathine, quantity: 40.27 mg/ml (equivalent: phenoxymethylpenicillin, qty 30 mg/ml) - oral liquid, suspension - excipient ingredients: sodium propyl hydroxybenzoate; sodium methyl hydroxybenzoate; butylated hydroxyanisole; polysorbate 80; xanthan gum; sucrose; purified water; sodium citrate dihydrate; potassium sorbate; citric acid; flavour - treatment of mild to moderately severe infections due to penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. for prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or sydenham's chorea and to prevent bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. note: oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth.

Malta - English - Medicines Authority

doc generici srl via turati, 40-20121, milano, italy - aripiprazole - oral solution - aripiprazole 1 mg/ml - psycholeptics

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

aspen pharmacare australia pty ltd - indometacin, quantity: 100 mg - suppository, moulded - excipient ingredients: macrogol 3350; purified water; glycerol; edetic acid; butylated hydroxyanisole; butylated hydroxytoluene; macrogol 8000 - indocid is indicated in active stage of: rheumatoid arthritis, osteoarthritis, degenerative joint disease of the hip, ankylosing spondylitis, gout. it is also indicated for: acute musculoskeletal disorders, such as bursitis, tendonitis, synovitis, tenosynovitis, tenosynovitis, capsulitis of the shoulder, sprains and strains; low back pain (commonly referred to as lumbago); inflammation, pain and oedema following orthopaedic surgical procedures and nonsurgical procedures associated with reduction and immobilisation of fractures or dislocations; pain and associated symptoms of primary dysmenorrhoea.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - simvastatin 10mg;  ;  ;  ;   - film coated tablet - 10 mg - active: simvastatin 10mg         excipient: butylated hydroxyanisole hyprolose hypromellose lactose magnesium stearate microcrystalline cellulose pregelatinised maize starch purified talc   purified water titanium dioxide - patients at high risk of coronary heart disease (chd) or with existing chd. in patients at high risk of chd (with or without hyperlipidaemia but with a total cholesterol of >3.5 mmol/l), i.e. patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd, simvastatin is indicated to: · reduce the risk of total mortality by reducing chd deaths. · reduce the risk of major vascular events (a composite of non-fatal myocardial infarction, chd death, stroke, or revascularisation procedures. · reduce the risk of stroke. · reduce the need for coronary revascularisation procedures (including coronary artery bypass grafting and percutaneous transluminal coronary angioplasty). · reduce the need for peripheral and other non-coronary revascularisation procedures. · reduce the risk of hospitalisation for angina pectoris. in patients with diabetes, simvastatin reduces the risk of developing peripheral macrovascular complications (a composite of peripheral revascularisation procedures, lower limb amputations, or leg ulcers. in hypercholesterolaemic patients with coronary heart disease, simvastatin slows the progress of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - simvastatin 20mg;  ;  ;  ;   - film coated tablet - 20 mg - active: simvastatin 20mg         excipient: butylated hydroxyanisole hyprolose hypromellose lactose magnesium stearate microcrystalline cellulose pregelatinised maize starch purified talc   purified water titanium dioxide - patients at high risk of coronary heart disease (chd) or with existing chd. in patients at high risk of chd (with or without hyperlipidaemia but with a total cholesterol of >3.5 mmol/l), i.e. patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd, simvastatin is indicated to: · reduce the risk of total mortality by reducing chd deaths. · reduce the risk of major vascular events (a composite of non-fatal myocardial infarction, chd death, stroke, or revascularisation procedures. · reduce the risk of stroke. · reduce the need for coronary revascularisation procedures (including coronary artery bypass grafting and percutaneous transluminal coronary angioplasty). · reduce the need for peripheral and other non-coronary revascularisation procedures. · reduce the risk of hospitalisation for angina pectoris. in patients with diabetes, simvastatin reduces the risk of developing peripheral macrovascular complications (a composite of peripheral revascularisation procedures, lower limb amputations, or leg ulcers. in hypercholesterolaemic patients with coronary heart disease, simvastatin slows the progress of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - simvastatin 40mg;  ;  ;  ;   - film coated tablet - 40 mg - active: simvastatin 40mg         excipient: butylated hydroxyanisole hyprolose hypromellose lactose magnesium stearate microcrystalline cellulose pregelatinised maize starch purified talc   purified water titanium dioxide - patients at high risk of coronary heart disease (chd) or with existing chd. in patients at high risk of chd (with or without hyperlipidaemia but with a total cholesterol of >3.5 mmol/l), i.e. patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd, simvastatin is indicated to: · reduce the risk of total mortality by reducing chd deaths. · reduce the risk of major vascular events (a composite of non-fatal myocardial infarction, chd death, stroke, or revascularisation procedures. · reduce the risk of stroke. · reduce the need for coronary revascularisation procedures (including coronary artery bypass grafting and percutaneous transluminal coronary angioplasty). · reduce the need for peripheral and other non-coronary revascularisation procedures. · reduce the risk of hospitalisation for angina pectoris. in patients with diabetes, simvastatin reduces the risk of developing peripheral macrovascular complications (a composite of peripheral revascularisation procedures, lower limb amputations, or leg ulcers. in hypercholesterolaemic patients with coronary heart disease, simvastatin slows the progress of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - simvastatin 80mg;  ;  ;  ;   - film coated tablet - 80 mg - active: simvastatin 80mg         excipient: butylated hydroxyanisole hyprolose hypromellose lactose magnesium stearate microcrystalline cellulose pregelatinised maize starch purified talc   purified water titanium dioxide - patients at high risk of coronary heart disease (chd) or with existing chd. in patients at high risk of chd (with or without hyperlipidaemia but with a total cholesterol of >3.5 mmol/l), i.e. patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd, simvastatin is indicated to: · reduce the risk of total mortality by reducing chd deaths. · reduce the risk of major vascular events (a composite of non-fatal myocardial infarction, chd death, stroke, or revascularisation procedures. · reduce the risk of stroke. · reduce the need for coronary revascularisation procedures (including coronary artery bypass grafting and percutaneous transluminal coronary angioplasty). · reduce the need for peripheral and other non-coronary revascularisation procedures. · reduce the risk of hospitalisation for angina pectoris. in patients with diabetes, simvastatin reduces the risk of developing peripheral macrovascular complications (a composite of peripheral revascularisation procedures, lower limb amputations, or leg ulcers. in hypercholesterolaemic patients with coronary heart disease, simvastatin slows the progress of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 10mg;   - film coated tablet - 10 mg - active: simvastatin 10mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate starch, pregelatinised (starch 1500) lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 20a54239 - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - simvastatin 20mg;   - film coated tablet - 20 mg - active: simvastatin 20mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate starch, pregelatinised (starch 1500) lactose monohydrate magnesium stearate microcrystalline cellulose opadry pink 20a54239 - paediatric patients with heterozygous familial hypercholesterolaemia: simvastatin is indicated as an adjunct to diet to reduce total-c, ldl-c, tg, and apo b levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolaemia (hefh).