Australië - Engels - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - levonorgestrel, quantity: 150 microgram; ethinylestradiol, quantity: 30 microgram - tablet, film coated - excipient ingredients: gelatin; hypromellose; iron oxide yellow; titanium dioxide; magnesium stearate; lactose monohydrate; maize starch; macrogol 4000 - oral contraception

Australië - Engels - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - valaciclovir hydrochloride, quantity: 556.275 mg (equivalent: valaciclovir, qty 500 mg) - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 400 - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. for the treatment of ophthalmic zoster. for the treatment of recurrent herpes labialis (cold sores) for the treatment of clinical episodes of genital herpes simplex infections. for the prevention of recurrent genital herpes. reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. in addition to therapy with valaciclovir, it is recommended that patients use safer sex practices (see section 4.4 special warnings and precautions for use). prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg) - tablet, film coated - excipient ingredients: hypromellose; lactose monohydrate; macrogol 3000; croscarmellose sodium; silicon dioxide; magnesium stearate; povidone; polysorbate 20; titanium dioxide; triacetin; microcrystalline cellulose - edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in antiretroviral treatment-naive adult patients with viral load less than or equal to 100,000 copies/ml at baseline. this indication is based on week 48 safety and efficacy analyses from 2 randomised double-blind, controlled phase iii trials in treatment-naive adult patients and on week 96 safety and efficacy analyses from the phase iib trial tmc278-c204 in treatment-naive adult patients (see clinical trials section).

Australië - Engels - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - emtricitabine, quantity: 200 mg; tenofovir disoproxil phosphate, quantity: 291 mg - tablet, film coated - excipient ingredients: mannitol; purified water; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; stearic acid; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake - treatment of hiv-1 infection tenofovir emt gh is indicated for the treatment of hiv infected adults over the age of 18 years, in combination with other antiretroviral agents.,pre-exposure prophylaxis tenofovir emt gh is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 in adults at high risk. this indication is based on clinical trials in men who have sex with men (msm) at high risk for hiv-1 infection and in heterosexual serodiscordant couples (see clinical studies).

Australië - Engels - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - levonorgestrel, quantity: 150 microgram; ethinylestradiol, quantity: 30 microgram - tablet, film coated - excipient ingredients: titanium dioxide; iron oxide red; gelatin; maize starch; macrogol 4000; magnesium stearate; hypromellose; lactose monohydrate - oral contraception

Australië - Engels - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - risperidone, quantity: 2 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; hypromellose; microcrystalline cellulose; propylene glycol; magnesium stearate; titanium dioxide; lactose monohydrate; sunset yellow fcf aluminium lake; sodium lauryl sulfate; purified talc; maize starch - treatment of schizophrenia and related psychoses. . short term treatment of acute mania associated with bipolar 1 disorder. . treatment of behavioural disturbances in dementia. . treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. . treatment of behavioural disorders associated with autism in children and adolescents.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - risperidone, quantity: 0.5 mg - tablet, film coated - excipient ingredients: titanium dioxide; maize starch; microcrystalline cellulose; hypromellose; purified talc; propylene glycol; sodium lauryl sulfate; iron oxide red; magnesium stearate; colloidal anhydrous silica; lactose monohydrate - treatment of schizophrenia and related psychoses. . short term treatment of acute mania associated with bipolar 1 disorder. . treatment of behavioural disturbances in dementia. . treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. . treatment of behavioural disorders associated with autism in children and adolescents.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - risperidone, quantity: 1 mg - tablet, film coated - excipient ingredients: sodium lauryl sulfate; magnesium stearate; hypromellose; maize starch; microcrystalline cellulose; propylene glycol; lactose monohydrate; purified talc; colloidal anhydrous silica - treatment of schizophrenia and related psychoses. . short term treatment of acute mania associated with bipolar 1 disorder. . treatment of behavioural disturbances in dementia. . treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. . treatment of behavioural disorders associated with autism in children and adolescents.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - risperidone, quantity: 4 mg - tablet, film coated - excipient ingredients: maize starch; microcrystalline cellulose; quinoline yellow aluminium lake; propylene glycol; purified talc; indigo carmine aluminium lake; colloidal anhydrous silica; lactose monohydrate; sodium lauryl sulfate; titanium dioxide; hypromellose; magnesium stearate - treatment of schizophrenia and related psychoses. . short term treatment of acute mania associated with bipolar 1 disorder. . treatment of behavioural disturbances in dementia. . treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. . treatment of behavioural disorders associated with autism in children and adolescents.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - risperidone, quantity: 3 mg - tablet, film coated - excipient ingredients: titanium dioxide; sodium lauryl sulfate; microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate; purified talc; magnesium stearate; quinoline yellow aluminium lake; hypromellose; propylene glycol; maize starch - treatment of schizophrenia and related psychoses. . short term treatment of acute mania associated with bipolar 1 disorder. . treatment of behavioural disturbances in dementia. . treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. . treatment of behavioural disorders associated with autism in children and adolescents.