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

accord healthcare pty ltd - sildenafil citrate, quantity: 70.25 mg (equivalent: sildenafil, qty 50 mg) - tablet, film coated - excipient ingredients: hypromellose; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; calcium hydrogen phosphate; titanium dioxide; lactose monohydrate; triacetin; indigo carmine aluminium lake - indicated for the treatment of erectile dysfunction in adult males. sildenafil citrate 50 mg tablets is not indicated for use by women.

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

accord healthcare pty ltd - sildenafil citrate, quantity: 140.5 mg (equivalent: sildenafil, qty 100 mg) - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; microcrystalline cellulose; hypromellose; calcium hydrogen phosphate; titanium dioxide; lactose monohydrate; triacetin; indigo carmine aluminium lake - indicated for the treatment of erectile dysfunction in adult males. sildenafil citrate 100 mg tablets is not indicated for use by women.

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

accord healthcare pty ltd - sildenafil citrate, quantity: 35.125 mg (equivalent: sildenafil, qty 25 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; hypromellose; calcium hydrogen phosphate; microcrystalline cellulose; magnesium stearate; titanium dioxide; lactose monohydrate; triacetin; indigo carmine aluminium lake - indicated for the treatment of erectile dysfunction in adult males. sildenafil citrate 25 mg tablets is not indicated for use by women.

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

accord healthcare pty ltd - sildenafil citrate, quantity: 70.25 mg (equivalent: sildenafil, qty 50 mg) - tablet, film coated - excipient ingredients: hypromellose; calcium hydrogen phosphate; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; lactose monohydrate; triacetin; indigo carmine aluminium lake - indicated for the treatment of erectile dysfunction in adult males. sildenafil citrate 50 mg tablets is not indicated for use by women.

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

accord healthcare pty ltd - sildenafil citrate, quantity: 35.125 mg (equivalent: sildenafil, qty 25 mg) - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; croscarmellose sodium; hypromellose; calcium hydrogen phosphate; titanium dioxide; lactose monohydrate; triacetin; indigo carmine aluminium lake - indicated for the treatment of erectile dysfunction in adult males. sildenafil citrate 25 mg tablets is not indicated for use by women.

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

bayer australia ltd - moxifloxacin, quantity: 400 mg (equivalent: moxifloxacin hydrochloride, qty 436.8 mg) - tablet, film coated - excipient ingredients: titanium dioxide; microcrystalline cellulose; hypromellose; ferric oxide; croscarmellose sodium; lactose monohydrate; magnesium stearate; macrogol 400 - avelox (moxifloxacin hydrochloride) tablets are indicated for the treatment of adults with infections caused by susceptible organisms in the conditions. acute bacterial sinusitis, community acquired pneumonia, acute exacerbations of chronic bronchitis. avelox iv (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults who require initial iv therapy for the treatment of infections in the conditions. community acquired pneumonia (caused by susceptible organisms). acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics. avelox iv (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents. (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin may be initiated. in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.

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

arrotex pharmaceuticals pty ltd - moxifloxacin hydrochloride monohydrate, quantity: 436.33 mg (equivalent: moxifloxacin, qty mg) - tablet, film coated - excipient ingredients: lactose; povidone; lactose monohydrate; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - moxifloxacin apo (moxifloxacin hydrochloride) tablets are indicated for the treatment of adults with infections caused by susceptible organisms in the conditions:,- acute bacterial sinusitis,- community acquired pneumonia,- acute exacerbations of chronic bronchitis,appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin apo may be initiated, in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.,consideration should be given to available official guidance on the appropriate use of antibacterial agents.

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

ferring pharmaceuticals pty ltd - budesonide, quantity: 9 mg - tablet, modified release - excipient ingredients: stearic acid; lecithin; microcrystalline cellulose; hyprolose; lactose monohydrate; silicon dioxide; magnesium stearate; methacrylic acid copolymer; purified talc; titanium dioxide; triethyl citrate - cortiment prolonged-release tablets are indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (uc) where 5-asa treatment is not sufficient or not tolerated.

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

lundbeck australia pty ltd - zuclopenthixol hydrochloride, quantity: 11.8 mg (equivalent: zuclopenthixol, qty 10 mg) - tablet, film coated - excipient ingredients: copovidone; purified talc; microcrystalline cellulose; lactose monohydrate; glycerol; potato starch; magnesium stearate; hydrogenated castor oil; titanium dioxide; hypromellose; macrogol 6000; iron oxide red - safety related notification and ammended text of the product information approved as described in the letter dated 28 may 2008 from ceu1. (sub#2008-1319-1) clopixol tablets: acute and chronic schizophrenia and other psychoses, especially those with symptoms such as hallucinations, delusions, thought disturbances, agitation, restlessness, hostility or aggressiveness. manic phase of manic depressive illness.

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

roche products pty ltd - cobimetinib fumarate, quantity: 22.2 mg (equivalent: cobimetinib, qty 20 mg) - tablet, film coated - excipient ingredients: titanium dioxide; macrogol 3350; magnesium stearate; microcrystalline cellulose; polyvinyl alcohol; purified talc; lactose monohydrate; croscarmellose sodium - cotellic is indicated for use in combination with zelboraf (vemurafenib) for the treatment of patients with unresectable or metastatic melanoma with braf v600 mutation