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

arrotex pharmaceuticals pty ltd - valaciclovir, quantity: 500 mg - tablet, film coated - excipient ingredients: magnesium stearate; povidone; crospovidone; microcrystalline cellulose; indigo carmine aluminium lake; titanium dioxide; hypromellose; polysorbate 80; macrogol 6000; macrogol 400 - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. treatment of ophthalmic zoster. treatment of clinical episodes of genital herpes simplex infections. for the prevention of recurrent genital herpes in immunocompromised patients with creatinine clearance of > 15 ml/min. for the 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 precautions). for 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)

sun pharma anz pty ltd - valaciclovir, quantity: 500 mg - tablet, film coated - excipient ingredients: povidone; magnesium stearate; indigo carmine aluminium lake; crospovidone; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 6000; macrogol 400 - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. treatment of ophthalmic zoster. treatment of clinical episodes of genital herpes simplex infections. for the prevention of recurrent genital herpes in immunocompromised patients with creatinine clearance of > 15 ml/min. for the 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 precautions). for 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)

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)

amneal pharma australia pty ltd - valaciclovir hydrochloride, quantity: 556 mg - tablet, film coated - excipient ingredients: magnesium stearate; crospovidone; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; indigo carmine aluminium lake - 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. ,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 - valaciclovir hydrochloride, quantity: 1112 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; magnesium stearate; crospovidone; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; indigo carmine aluminium lake - 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. ,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 - valaciclovir hydrochloride, quantity: 1112 mg - tablet, film coated - excipient ingredients: magnesium stearate; povidone; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; indigo carmine aluminium lake - 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. ,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)

sun pharma anz pty ltd - valaciclovir, quantity: 500 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; crospovidone; magnesium stearate; indigo carmine aluminium lake; titanium dioxide; hypromellose; polysorbate 80; macrogol 6000; macrogol 400 - for the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. treatment of ophthalmic zoster. treatment of clinical episodes of genital herpes simplex infections. for the prevention of recurrent genital herpes in immunocompromised patients with creatinine clearance of > 15 ml/min. for the 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 precautions). for prophylaxis of cytomegalovirus (cmv) infection and disease following solid organ transplantation in patients at risk of cmv disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - valaciclovir hydrochloride 556.275mg equivalent to valaciclovir 500 mg - film coated tablet - 500 mg - active: valaciclovir hydrochloride 556.275mg equivalent to valaciclovir 500 mg excipient: crospovidone indigo carmine aluminium lake magnesium stearate microcrystalline cellulose opadry blue 02c50740 povidone - valaciclovir rbx is indicated for the treatment of herpes zoster (shingles) and the reduction of zoster associated pain, which includes acute and post herpetic neuralgia, when given to immunocompetent patients in infection of less than 72 hours duration.

New Zealand - English - Medsafe (Medicines Safety Authority)

haleon new zealand ulc - aciclovir 5%{relative}; aciclovir 5%{relative} - topical cream - 5% w/w - active: aciclovir 5%{relative} excipient: cetostearyl alcohol dimeticone liquid paraffin poloxamer 407 propylene glycol purified water sodium laurilsulfate white soft paraffin active: aciclovir 5%{relative} excipient: cetostearyl alcohol dimeticone arlacel 165 = 0.75% glycerol monostearate + 0.75% macgogol stearate 100 liquid paraffin poloxamer 407 propylene glycol purified water sodium laurilsulfate white soft paraffin - for the treatment of herpes simplex virus infections of the lips and face (recurrent herpes labialis)

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

amneal pharma australia pty ltd - aciclovir, quantity: 800 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; colloidal anhydrous silica - aciclovir tablets are indicated 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 advaned symptomatic hiv disease cd4 + counts < 150 x 10(6)/l). in accordance with details specified in the "indications" and the "dosage and administration" sections of the approved product information provided as attachment 1.