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

juno pharmaceuticals pty ltd - darunavir, quantity: 800 mg - tablet, film coated - excipient ingredients: silicified microcrystalline cellulose; macrogol 4000; sodium chloride; iron oxide red; purified talc; titanium dioxide; hyprolose; crospovidone; polacrilin potassium; magnesium stearate; colloidal anhydrous silica; polyvinyl alcohol - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 600 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; purified talc; polyvinyl alcohol; hyprolose; polacrilin potassium; macrogol 4000; sodium chloride; titanium dioxide; iron oxide red; silicified microcrystalline cellulose; colloidal anhydrous silica; iron oxide yellow - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

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

juno pharmaceuticals pty ltd - darunavir, quantity: 400 mg - tablet, film coated - excipient ingredients: sodium chloride; hyprolose; macrogol 4000; titanium dioxide; crospovidone; polacrilin potassium; iron oxide red; colloidal anhydrous silica; iron oxide yellow; purified talc; silicified microcrystalline cellulose; polyvinyl alcohol; magnesium stearate - adult patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adult patients.,paediatric patients,darunavir juno (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

Ireland - English - HPRA (Health Products Regulatory Authority)

profile pharma limited - colistin mesilate sodium - powder for nebuliser solution - 1 million international unit - polymixins

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

arrotex pharmaceuticals pty ltd - oxazepam, quantity: 30 mg - tablet, uncoated - excipient ingredients: magnesium stearate; methylcellulose; polacrilin potassium; lactose monohydrate - indications as at 25 feb 2005 : management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety associated with depression is also responsive to murelax therapy. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the physician should periodically reassess the usefulness of the drug for the individual patient. alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are responsive to therapy.

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

sun pharma anz pty ltd - fingolimod hydrochloride, quantity: 560 microgram (equivalent: fingolimod, qty 500 microgram) - capsule, hard - excipient ingredients: polacrilin potassium; crospovidone; colloidal anhydrous silica; magnesium stearate; gelatin; sodium lauryl sulfate; titanium dioxide; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - fingolimod sun is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

aspen pharma pty ltd - oxazepam, quantity: 15 mg - tablet, uncoated - excipient ingredients: magnesium stearate; polacrilin potassium; lactose monohydrate; microcrystalline cellulose - indications as at 22 feb 1995 : management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety associated with depression is also responsive to serepax therapy. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the physician should periodically reassess the usefulness of the drug for the individual patient. alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are reponsive to therapy.

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

aspen pharma pty ltd - oxazepam, quantity: 30 mg - tablet, uncoated - excipient ingredients: magnesium stearate; methylcellulose; polacrilin potassium; lactose monohydrate; sunset yellow fcf - indications as at 22 feb 1995 : management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety associated with depression is also responsive to serepax therapy. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the physician should periodically reassess the usefulness of the drug for the individual patient. alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are reponsive to therapy.

Israel - English - Ministry of Health

rafa laboratories ltd - colistimethate sodium - powder for concentrate for infusion - colistimethate sodium 1000000 u/vial - colistin - colistin - antibiotic for treatment of infections caused by micro-organisms sensitive to colistin.

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

arrotex pharmaceuticals pty ltd - solifenacin succinate, quantity: 10 mg - tablet, orally disintegrating - excipient ingredients: lactose monohydrate; sucralose; polacrilin potassium; sodium stearylfumarate; croscarmellose sodium; mannitol; hypromellose; flavour - solicare odt is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.