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

douglas pharmaceuticals australia pty ltd - isotretinoin, quantity: 40 mg - capsule, soft - excipient ingredients: titanium dioxide; glycerol; sorbitol solution (70 per cent) (non-crystallising); hydrogenated soya oil; dl-alpha-tocopherol; soya oil; disodium edetate; butylated hydroxyanisole; sunset yellow fcf; gelatin; partially hydrogenated soya oil; yellow beeswax; purified water - oratane is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cyctic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

arrotex pharmaceuticals pty ltd - aripiprazole, quantity: 10 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; maize starch; hyprolose; magnesium stearate; lactose monohydrate; microcrystalline cellulose - aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

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

arrotex pharmaceuticals pty ltd - aripiprazole, quantity: 20 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; colloidal anhydrous silica; hyprolose; magnesium stearate - aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

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

aurobindo pharma australia pty ltd - pantoprazole sodium sesquihydrate -

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

strides pharma science pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.1 mg (equivalent: pantoprazole, qty 40 mg) - tablet, enteric coated - excipient ingredients: triethyl citrate; sodium carbonate; hyprolose; iron oxide yellow; calcium stearate; crospovidone; hypromellose; mannitol; methacrylic acid - ethyl acrylate copolymer (1:1) - 1. for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:- i) duodenal ulcer, ii) gastric ulcer, iii) gastro-oesophageal reflux disease (gord): symptomatic gord. the treatment of heartburn and other symptoms associated with gord; reflux oesophagitis iv) gastrointestinal lesions refractory h2 blockers v) zollinger-ellison syndrome. patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. for eradication of helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics; i) clarithromycin and amoxicillin, or ii) clarithromycin and metronidazole, or iii) amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism. 4. pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism. 5. prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (nsaids) in increased risk patients with a need for continuous non-selective nsaid treatment.

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

strides pharma science pty ltd - isotretinoin, quantity: 40 mg - capsule, soft - excipient ingredients: purified water; titanium dioxide; dl-alpha-tocopherol; sorbitol solution (70 per cent) (non-crystallising); yellow beeswax; butylated hydroxyanisole; soya oil; partially hydrogenated soya oil; sunset yellow fcf; glycerol; disodium edetate; hydrogenated soya oil; gelatin - dermatane is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cyctic acne who are unresponsive to conventional therapy, including systemic antibiotics.

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

strides pharma science pty ltd - isotretinoin, quantity: 5 mg - capsule, soft - excipient ingredients: gelatin; dl-alpha-tocopherol; soya oil; titanium dioxide; purified water; yellow beeswax; sorbitol solution (70 per cent) (non-crystallising); butylated hydroxyanisole; partially hydrogenated soya oil; hydrogenated vegetable oil; disodium edetate; glycerol - dermatane is indicated for the treatment of patients with severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. if a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

stiefel laboratories (uk) ltd - erythromycin; isotretinoin - cutaneous gel - 20mg/1gram ; 500microgram/1gram

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - imatinib mesilate - tablet - 100mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

wockhardt uk ltd - imatinib mesilate - tablet - 400mg