澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - amitriptyline hydrochloride, quantity: 10 mg - tablet - excipient ingredients: maize starch; titanium dioxide; lactose monohydrate; macrogol 6000; hypromellose; purified talc; crospovidone; colloidal anhydrous silica; brilliant blue fcf aluminium lake; magnesium stearate; microcrystalline cellulose - for the treatment of major depression. amitriptyline 50 mg tablets are indicated only for the maintenance treatment of major depression ,nocturnal enuresis where organic pathology has been excluded.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - amitriptyline hydrochloride, quantity: 25 mg - tablet - excipient ingredients: titanium dioxide; purified talc; hypromellose; microcrystalline cellulose; macrogol 6000; quinoline yellow aluminium lake; lactose monohydrate; crospovidone; colloidal anhydrous silica; magnesium stearate; maize starch - for the treatment of major depression. amitriptyline 50 mg tablets are indicated only for the maintenance treatment of major depression ,nocturnal enuresis where organic pathology has been excluded.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine juno is indicated for the treatment of patients with intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia (cmmol (10-29 percent marrow blasts without myeloproliferative disorder)), acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azadine is indicated for the treatment of patients with intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia (cmmol (10-29 percent marrow blasts without myeloproliferative disorder)), acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

abraxis bioscience australia pty ltd - paclitaxel, quantity: 100 mg - injection, powder for - excipient ingredients: albumin; sodium octanoate; sodium acetyltryptophanate - metastatic breast cancer abraxane is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. non-small cell lung cancer abraxane, in combination with carboplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation. metastatic adenocarcinoma of the pancreas abraxane, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

abraxis bioscience australia pty ltd - paclitaxel, quantity: 250 mg - injection, powder for - excipient ingredients: albumin; sodium octanoate; sodium acetyltryptophanate - metastatic breast cancer abraxane is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. non-small cell lung cancer abraxane, in combination with carboplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation. metastatic adenocarcinoma of the pancreas abraxane, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 150 mg - injection, solution - excipient ingredients: polysorbate 20; histidine; arginine hydrochloride; histidine hydrochloride monohydrate; water for injections - allergic asthma,children 6 to < 12 years of age - in children aged 6 to <12 years, xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,adults and adolescents 12 years of age and above -xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,chronic rhinosinusitis with nasal polyps (crswnp),xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe crswnp with inadequate response to intranasal corticosteroids. recommended dosing is determined by serum immunoglobulin e levels and body weight corresponding to the recommended dose range in the product information (see section 4.2 dose and method of administration).,chronic spontaneous urticaria (csu),xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - omalizumab, quantity: 75 mg - injection, solution - excipient ingredients: arginine hydrochloride; water for injections; histidine; histidine hydrochloride monohydrate; polysorbate 20 - allergic asthma,children 6 to < 12 years of age - in children aged 6 to <12 years, xolair is indicated as add-on therapy to improve asthma control in patients with severe allergic asthma who have documented exacerbations despite daily high dose inhaled corticosteroids, and who have immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,adults and adolescents 12 years of age and above -xolair is indicated for the management of adult and adolescent patients with moderate to severe allergic asthma, who are already being treated with inhaled steroids, and who have serum immunoglobulin e levels corresponding to the recommended dose range (see table 1 in section 4.2 dose and method of administration).,chronic rhinosinusitis with nasal polyps (crswnp),xolair is indicated as add-on treatment in adult patients (18 years of age and above) for the treatment of severe crswnp with inadequate response to intranasal corticosteroids. recommended dosing is determined by serum immunoglobulin e levels and body weight corresponding to the recommended dose range in the product information (see section 4.2 dose and method of administration).,chronic spontaneous urticaria (csu),xolair is indicated for adults and adolescents (12 years of age and above) with chronic spontaneous urticaria who remain symptomatic despite h1 antihistamine treatment.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - sumatriptan succinate, quantity: 16.8 mg/ml (equivalent: sumatriptan, qty 12 mg/ml) - injection, solution - excipient ingredients: water for injections; sodium chloride - sumatriptan (imigran) tablets, injection and nasal spray are indicated for the acute relief of migraine attacks with or without aura. sumatriptan (imigran) injection is also indicated for the acute treatment of cluster headaches. there is no information available on the use of imigran injection in the treatment of basilar or hemiplegic migraine.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - sumatriptan succinate, quantity: 16.8 mg/ml (equivalent: sumatriptan, qty 12 mg/ml) - injection, solution - excipient ingredients: sodium chloride; water for injections - sumatriptan (imigran) tablets, injection and nasal spray are indicated for the acute relief of migraine attacks with or without aura. sumatriptan (imigran) injection is also indicated for the acute treatment of cluster headaches. there is no information available on the use of imigran injection in the treatment of basilar or hemiplegic migraine.