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

mayne pharma international pty ltd - oxycodone hydrochloride, quantity: 5 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium starch glycollate type a; silicon dioxide; lactose monohydrate; maize starch; stearic acid - mayne pharma oxycodone ir is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Malta - Inggeris - Medicines Authority

laboratorios q pharma, s.l c/ moratín, 15 entlo. oficinas 6-7, alicante 03008, spain - dutasteride, tamsulosin hydrochloride - hard capsule - tamsulosin hydrochloride 0.4 mg dutasteride 0.5 mg - urologicals

Kesatuan Eropah - Inggeris - EMA (European Medicines Agency)

acino pharma gmbh  - clopidogrel - peripheral vascular diseases - antithrombotic agents - clopidogrel is indicated in adults for the prevention of atherothrombotic events in:patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.patients suffering from acute coronary syndrome:- non st segment elevation acute coronary syndrome (unstable angina or non q wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa).- st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy.for further information please refer to section 5.1.

Kesatuan Eropah - Inggeris - EMA (European Medicines Agency)

acino pharma gmbh - clopidogrel - peripheral vascular diseases; stroke; myocardial infarction - antithrombotic agents - clopidogrel is indicated in adults for the prevention of atherothrombotic events in:patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.for further information please refer to section 5.1.

Kesatuan Eropah - Inggeris - EMA (European Medicines Agency)

acino pharma gmbh - clopidogrel - peripheral vascular diseases; stroke; myocardial infarction - antithrombotic agents - clopidogrel is indicated in adults for the prevention of atherothrombotic events in:patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.for further information please refer to section 5.1.

Kesatuan Eropah - Inggeris - EMA (European Medicines Agency)

teva pharma b.v. - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated in the treatment of type-2 diabetes mellitus as monotherapy: , in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. , pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. after initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in hba1c). in patients who fail to show an adequate response, pioglitazone should be discontinued. in light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.,

Kesatuan Eropah - Inggeris - EMA (European Medicines Agency)

1 a pharma gmbh - rivastigmine - alzheimer disease; dementia; parkinson disease - psychoanaleptics, - symptomatic treatment of mild to moderately severe alzheimer's dementia.symptomatic treatment of mild to moderately severe dementia in patients with idiopathic parkinson's disease.

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

mayne pharma international pty ltd - erythromycin, quantity: 250 mg - capsule, enteric - excipient ingredients: povidone; monobasic potassium phosphate; lactose monohydrate; gelatin; carbon black; sunset yellow fcf; shellac; indigo carmine; purified water; cellacefate; erythrosine; diethyl phthalate - mayne pharma erythromycin is indicated in children and adults for the treatment of the following conditions: upper respiratory tract infections of mild to moderate degree caused by streptococcus pyogenes (group a beta haemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae). lower respiratory tract infections of mild to moderate severity caused by streptococcus pyogenes (group a beta hemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae), acute and chronic bronchitis, pneumonia. sinusitis caused by streptococcus pneumoniae, streptococcus pyogenes. otitis media due to streptococcus pneumoniae, streptococcus pyogenes. respiratory tract infections due to mycoplasma pneumonia (eaton's agent). skin, and skin structure infections of mild to moderate severity caused by streptococcus pyogenes and staphylococcus aureus (resistant staphylococci may emerge during treatment). bordetella pertussis: erythromycin produces early elimination of the causative organism from the nasopharynx although the clinical course of the disease is not altered; therapeutic doses should be continued for at least 10 days. diphtheria: as an adjunct to antitoxin infections due to corynebacterium diphtheriae, to prevent establishment of carriers and to eradicate the organism in carriers. erythrasma: in the treatment of infections due to corynebacterium minutissimum. infections due to listera monocytogenes. non-gonococcal urethritis: chlamydia trachomatis and ureaplasma urealyticum have been shown to be sensitive to erythromycin and clinical studies have demonstrated its efficacy in urethritis due to these organisms. a minimum of 10 days therapy appears to be required. chlamydia trachomatis infection (excluding non-gonococcal urethritis): erythromycin has been shown to be effective in the treatment of trachoma or inclusion-body conjunctivitis and pneumonia in infants caused by chlamydia trachomatis. campylobacter fetus (subspecies) jejuni: infections due to this organism when antibiotic therapy is indicated. primary syphilis caused by treponema pallidum: erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. in the treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the followup after therapy. legionnaires' disease caused by legionella pneumophila: although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating legionnaires' disease. prevention of initial attacks of rheumatic fever: penicillin is considered by the american heart association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of group a beta - haemolytic streptococcal infections of the upper respiratory tract e.g. tonsillitis or pharyngitis). erythromycin is indicated for the treatment of penicillin allergic patients. a therapeutic dose should be administered for 10 days. prevention of recurrent attacks of rheumatic fever: penicillin or sulphonamides are considered by the american heart association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. in patients who are allergic to penicillin and sulphonamides, oral erythromycin is recommended by the american heart association in the long term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever). prevention of bacterial endocarditis: although no controlled clinical efficacy trials have been conducted, oral erythromycin has been suggested by the american heart association and the american dental association in a regimen for prophylaxis against bacterial endocarditis in patients sensitive to penicillin who have congenital heart disease, or rheumatic or other acquired valvular heart disease when they undergo dental or surgical procedures of the upper respiratory tract. erythromycin is not suitable prior to genitourinary or gastrointestinal tract surgery.

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

seed pharma pty ltd - carbimazole, quantity: 5 mg - tablet - excipient ingredients: croscarmellose sodium; lactose; magnesium stearate - therapy of hyperthyroidism. definitive therapy: induction of a permanent remission, in either primary or secondary thyrotoxicosis. preparation for thyroidectomy. before and after radioactive iodine treatment.

Israel - Inggeris - Ministry of Health

mbi pharma ltd., israel - dexamethasone phosphate ( as sodium phosphate ) - solution for injection / infusion - dexamethasone phosphate ( as sodium phosphate ) 4 mg/ml - dexamethasone - dexamethasone kern pharma is indicated in the treatment of:• endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia.• allergy: severe or disabling allergic conditions resistant to conventional treatments, as in: bronchial asthma, contact or atopical dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs.• ophtalmic: serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers.• inflammatory bowel dis.: systemic treatment in exacerbations of ulcerative colitis and regional enteritis.• dermatological diseases (pemphigus, stevens johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides) • respiratory diseases (symptomatic sarcoidosis, berylliosis, loeffler's syndrome)• haematological: acquired )autoimmune( haemolytic anaemia, idiopathic thrombocytopenic purpura in adult, pure red cell aplasia• nephrotic syndrome of the idioplathic type or that due to lupus erythematosus• cerebral edema caused by brain tumor, neurosurgery, brain abscess, bacterial meningitis• collagen diseases: active rheumatoid arthritis with severe progressive course, fast destructive remitting forms and / or extra-articular manifestations, juvenile idiopathic arthritis with severe systemic-onset form (still's disease) or locally with no control, rheumatic fever with carditis, dermatomyositis, polymyositis, sle, temporal arteritis.• infectious diseases: bacterial meningitis – adjunct to antibiotics in suspected pneumococcal meningitis and tb meningitis. severe infectious diseases with toxic states (eg tuberculosis, typhoid, brucellosis;. only with simultaneous anti-infective therapy)• fetal lung maturation• chemotherapy – associated nausea and vomiting• multiple myeloma – part of chemotherapy protocols (eg vad)• prevention and treatment of acute mountain sickness/hace