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

medis pharma pty ltd - sertraline hydrochloride, quantity: 55.9 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; methylcellulose; magnesium stearate; hypromellose; hyprolose; titanium dioxide; indigo carmine; colloidal anhydrous silica; macrogol 8000 - sertraline is indicated in adults for the treatment of 1) major depression; 2) premenstrual dysphoric disorder (pmdd) as defined by dsm-iv criteria.

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

arrotex pharmaceuticals pty ltd - atomoxetine hydrochloride, quantity: 114 mg (equivalent: atomoxetine, qty 100 mg) - capsule, hard - excipient ingredients: iron oxide yellow; gelatin; pregelatinised maize starch; titanium dioxide; iron oxide red; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - for the treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

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

arrotex pharmaceuticals pty ltd - atomoxetine hydrochloride, quantity: 91.2 mg (equivalent: atomoxetine, qty 80 mg) - capsule, hard - excipient ingredients: gelatin; iron oxide yellow; iron oxide red; pregelatinised maize starch; titanium dioxide; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - for the treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

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

arrotex pharmaceuticals pty ltd - atomoxetine hydrochloride, quantity: 68.3 mg (equivalent: atomoxetine, qty 60 mg) - capsule, hard - excipient ingredients: gelatin; indigo carmine; titanium dioxide; pregelatinised maize starch; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - for the treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

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

arrotex pharmaceuticals pty ltd - atomoxetine hydrochloride, quantity: 45.5 mg (equivalent: atomoxetine, qty 40 mg) - capsule, hard - excipient ingredients: gelatin; pregelatinised maize starch; iron oxide yellow; indigo carmine; titanium dioxide; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - for the treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

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

arrotex pharmaceuticals pty ltd - atomoxetine hydrochloride, quantity: 28.5 mg (equivalent: atomoxetine, qty 25 mg) - capsule, hard - excipient ingredients: iron oxide yellow; gelatin; titanium dioxide; pregelatinised maize starch; indigo carmine; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - for the treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

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

arrotex pharmaceuticals pty ltd - atomoxetine hydrochloride, quantity: 20.5 mg (equivalent: atomoxetine, qty 18 mg) - capsule, hard - excipient ingredients: iron oxide yellow; pregelatinised maize starch; gelatin; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - for the treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

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

arrotex pharmaceuticals pty ltd - atomoxetine hydrochloride, quantity: 11.4 mg (equivalent: atomoxetine, qty 10 mg) - capsule, hard - excipient ingredients: gelatin; titanium dioxide; pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - for the treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

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

inova pharmaceuticals (australia) pty ltd - metronidazole, quantity: 7.5 mg/g - gel - excipient ingredients: carbomer 974p; propylene glycol; sodium hydroxide; disodium edetate; propyl hydroxybenzoate; methyl hydroxybenzoate; purified water - zidoval vaginal gel 0.75% is indicated in the treatment of symptomatic bacterial vaginosis (formerly referred to as haemophilus vaginalis vaginitis, gardnerella vaginalis vaginitis, non-specific vaginitis, corynebacterium vaginale vaginitis or anaerobic vaginosis). note: for purpose of this indicated, a clincial diagnosis of bacterial vaginosis is usually defined by the presence of at least three of the following four criteria: a) vaginal discharge ph of greater than 4.5, b) a vaginal discharge emitting a "fishy" amine odour when mixed with a 10% koh solution, c) a vaginal discharge containing clue cells on wet mount microscopy examination, d) a gram stain consistent with a diagnosis of bacterial vaginosis (lactobacillus morphotype absent of markedly decreased, gardnerella morphotype predominant flora, white blood cells absent or few, mobiluncus morphotype may or may not be present). a diagnosis of bacterial vaginosis requires that other pathogens which may be associated with genital infection, such as trichomonas vaginalis, candida albicans, chlamydia trachomatis and neisseria gonorrhoeae, should be ruled out be appropriate laboratory means.

European Union - English - EMA (European Medicines Agency)

novartis europharm ltd - midostaurin - leukemia, myeloid, acute; mastocytosis - antineoplastic agents - rydapt is indicated:in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (aml) who are flt3 mutation positive (see section 4.2);as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (asm), systemic mastocytosis with associated haematological neoplasm (sm ahn), or mast cell leukaemia (mcl).