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

lupin australia pty limited - escitalopram oxalate, quantity: 6.385 mg (equivalent: escitalopram, qty 5 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; purified talc; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400 - - treatment of major depression. - treatment of social anxiety disorder (social phobia). - treatment of generalised anxiety disorder. - treatment of obsessive-compulsive disorder.

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

alphapharm pty ltd - mirtazapine, quantity: 45 mg - tablet, film coated - excipient ingredients: magnesium stearate; maize starch; lactose; hyprolose; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; hypromellose; macrogol 4000 - treatment of major depression including relapse prevention.

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

novartis pharmaceuticals australia pty ltd - pazopanib hydrochloride, quantity: 216.7 mg - tablet, film coated - excipient ingredients: povidone; magnesium stearate; sodium starch glycollate; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400 - votrient is indicated for the treatment of advanced and/or metastatic renal cell carcinoma (rcc). votrient is indicated for the treatment of patients with advanced (unresectable and/or metastatic) soft tissue sarcoma (sts) in patients who, unless otherwise contraindicated, have received prior chemotherapy including an anthracycline treatment. the phase iii trial population excluded patients with gastrointestinal stromal tumour (gist) or adipocytic soft tissue sarcoma.

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

novartis pharmaceuticals australia pty ltd - pazopanib hydrochloride, quantity: 433.4 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 400 - votrient is indicated for the treatment of advanced and/or metastatic renal cell carcinoma (rcc). votrient is indicated for the treatment of patients with advanced (unresectable and/or metastatic) soft tissue sarcoma (sts) in patients who, unless otherwise contraindicated, have received prior chemotherapy including an anthracycline treatment. the phase iii trial population excluded patients with gastrointestinal stromal tumour (gist) or adipocytic soft tissue sarcoma.

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

arrotex pharmaceuticals pty ltd - aciclovir, quantity: 800 mg - tablet - excipient ingredients: magnesium stearate; croscarmellose sodium; indigo carmine; microcrystalline cellulose; colloidal anhydrous silica; brilliant blue fcf - for use in adult patients for: 1. the treatment of first episode (primary or non-primary) genital herpes and the management of recurrent episodes of genital herpes in certain patients; 2. the treatment of acute attacks of herpes zoster (shingles), when the duration of rash is less than 72 hours; 3. the management of patients with advanced symptomatic hiv disease (cd4+counts, <150 x 10exp6/l). for use in accordance with details specified in the "indications" and the "dosage and adminsitration" sections of the approved product information document. a copy is provided as attachment 1.

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

arrotex pharmaceuticals pty ltd - valaciclovir hydrochloride monohydrate, quantity: 584 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; macrogol 8000; hypromellose; titanium dioxide; indigo carmine aluminium lake; stearic acid - 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 in immunocompromised patients. . prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

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

arrotex pharmaceuticals pty ltd - valaciclovir hydrochloride monohydrate, quantity: 1168 mg - tablet, film coated - excipient ingredients: stearic acid; macrogol 8000; titanium dioxide; hypromellose; colloidal anhydrous silica - 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 in immunocompromised patients. . prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

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

amneal pharma australia pty ltd - citalopram hydrobromide, quantity: 12.495 mg - tablet, film coated - excipient ingredients: maize starch; microcrystalline cellulose; purified water; macrogol 400; hypromellose; lactose monohydrate; magnesium stearate; croscarmellose sodium; pregelatinised maize starch; purified talc; titanium dioxide - treatment of major depression

Australia - English - 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.

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

alphapharm pty ltd - valaciclovir hydrochloride, quantity: 611.22 mg (equivalent: valaciclovir, qty 500 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; 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 vaclovir, it is recommended that patients use safer sex practices (see section 4.4). prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.