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

arrotex pharmaceuticals pty ltd - amlodipine besilate, quantity: 13.9 mg; hydrochlorothiazide, quantity: 25 mg; olmesartan medoxomil, quantity: 40 mg - tablet, film coated - excipient ingredients: isopropyl alcohol; silicified microcrystalline cellulose; povidone; lactose monohydrate; pregelatinised maize starch; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - apo-olmesartan/amlodipine/hctz 40/10/25 mg is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. this fixed dose combination is not indicated for initial therapy.

Singapore - English - HSA (Health Sciences Authority)

amgen biotechnology singapore pte ltd - apremilast (in beige tablet); apremilast (in brown tablet); apremilast (in pink tablet) - tablet, film coated - apremilast (in beige tablet) 30 mg; apremilast (in brown tablet) 20 mg; apremilast (in pink tablet) 10 mg

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

arrotex pharmaceuticals pty ltd - roxithromycin, quantity: 150 mg - tablet, film coated - excipient ingredients: hypromellose; colloidal anhydrous silica; glucose; magnesium stearate; purified talc; povidone; titanium dioxide; maize starch; propylene glycol; hyprolose - adults: roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections in adults caused by or likely to be caused by susceptible microorganisms: upper respiratory tract infection: acute pharyngitis, tonsillitis, and sinusitis. lower respiratory tract infection: acute bronchitis and acute exacerbation of chronic bronchitis; community acquired pneumonia. skin and skin structure infections. nongonococcal urethritis. children: roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible micro-organisms: acute pharyngitis. acute tonsillitis. impetigo. appropriate culture and susceptibility tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

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

arrotex pharmaceuticals pty ltd - roxithromycin, quantity: 300 mg - tablet, film coated - excipient ingredients: glucose; propylene glycol; colloidal anhydrous silica; hyprolose; maize starch; povidone; hypromellose; magnesium stearate; titanium dioxide; purified talc - adults: roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections in adults caused by or likely to be caused by susceptible microorganisms: upper respiratory tract infection: acute pharyngitis, tonsillitis, and sinusitis. lower respiratory tract infection: acute bronchitis and acute exacerbation of chronic bronchitis; community acquired pneumonia. skin and skin structure infections. nongonococcal urethritis. children: roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible micro-organisms: acute pharyngitis. acute tonsillitis. impetigo. appropriate culture and susceptibility tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

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

southern cross pharma pty ltd - omeprazole, quantity: 20 mg - tablet, enteric coated - excipient ingredients: iron oxide black; microcrystalline cellulose; povidone; iron oxide red; crospovidone; purified talc; lactose monohydrate; hypromellose phthalate; magnesium stearate; triacetin; ascorbyl palmitate - omeprazole tablets are indicated for: a. gastro-oesophageal reflux disease (gord): 1. symptomatic gord: the relief of heartburn and other symptoms associated with gord. 2. erosive oesophagitis: the treatment and prevention of relapse. b. peptic ulcers: 1. the treatment of duodenal and gastric ulcer. 2. combination therapy for the treatment of peptic ulcer disease associated with heliobacter pylori infection. 3. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be heliobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. c. zollinger-ellison syndrome: the treatment of zollinger-ellison syndrome.

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

ms health pty ltd - misoprostol, quantity: 200 microgram - tablet - excipient ingredients: hypromellose; microcrystalline cellulose; sodium starch glycollate; hydrogenated castor oil - gymiso is indicated in females of childbearing age for the medical termination of a developing intrauterine pregnancy in sequential combination with a mifepristone 200 mg tablet, up to 49 days of gestation.

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

alphapharm pty ltd - amitriptyline hydrochloride, quantity: 50 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; pregelatinised maize starch; colloidal anhydrous silica; lactose monohydrate; magnesium stearate; purified talc; disodium edetate; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000; iron oxide black - endep 50mg tablets are indicated only for the maintenance treatment of major depression. (see precautions). nocturnal enuresis where organic pathology has been excluded.

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

alphapharm pty ltd - doxepin hydrochloride, quantity: 56.5 mg (equivalent: doxepin, qty 50 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; hypromellose; lactose monohydrate; carnauba wax; purified talc; sodium starch glycollate; diethyl phthalate; magnesium stearate; titanium dioxide; indigo carmine; erythrosine; povidone - the 50mg and 75mg tablets are indicated only for the maintenance treatment of major depression. (see precautions).

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - enrofloxacin - tablet - 15 mg/tablet - enrofloxacin - cats, dogs - antibacterial

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - enrofloxacin - tablet - 150 mg/tablet - enrofloxacin - dogs - antibacterial