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

sandoz pty ltd - rabeprazole sodium, quantity: 20 mg - tablet, enteric coated - excipient ingredients: iron oxide yellow; sodium stearylfumarate; hypromellose phthalate; calcium hydroxide; hypromellose; purified talc; titanium dioxide; dibutyl sebacate; hyprolose; mannitol - rabeprazole sandoz is indicated for treatment and prevention of relapse of gastro-oesophageal reflux disease; symptomatic treatment of gastro-oesophageal reflux disease; treatment of duodenal ulcers; treatment of gastric ulcers. patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (nsaids) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,rabeprazole sandoz is also indicated, in combination with clarithromycin and amoxycillin, for eradication of helicobacter pylori in patients with peptic ulcer disease or chronic gastritis; and healing of peptic ulcers in patients with helicobacter pylori associated ulcers.

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

sandoz pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol - bortezomib sandoz, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.,bortezomib sandoz, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.,bortezomib sandoz is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib sandoz in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. aripiprazole sandoz is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. aripiprazole sandoz is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.,

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - pregabalin - anxiety disorders; neuralgia; epilepsy - antiepileptics, - neuropathic painpregabalin sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults.epilepsypregabalin sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.generalised anxiety disorderpregabalin sandoz is indicated for the treatment of generalised anxiety disorder (gad) in adults.

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - pregabalin - anxiety disorders; epilepsy - antiepileptics, - epilepsypregabalin sandoz gmbh is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.generalised anxiety disorderpregabalin sandoz gmbh is indicated for the treatment of generalised anxiety disorder (gad) in adults.

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

sandoz pty ltd - codeine phosphate hemihydrate, quantity: 12.8 mg; ibuprofen, quantity: 200 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400 - for the temporary relief of acute moderate pain and inflammation in patients over the age of 12 years (see also contraindications and paediatric use)

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

sandoz pty ltd - docetaxel, quantity: 80 mg - injection, concentrated - excipient ingredients: ethanol; polysorbate 80; citric acid; nitrogen - docetaxel sandoz is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. docetaxel sandoz in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. docetaxel sandoz in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease. docetaxel sandoz in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. doxorubicin and cyclophosphamide followed by docetaxel sandoz in combination with trastuzumab (ac-th) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel sandoz in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of =1cm and < 7cm. docetaxel sandoz is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy. docetaxel sandoz is indicated for the treatment of metastatic carcinoma of the ovary after failure of firstline or subsequent chemotherapy. docetaxel sandoz is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. docetaxel sandoz, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

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

sandoz pty ltd - docetaxel, quantity: 20 mg - injection, concentrated - excipient ingredients: polysorbate 80; citric acid; ethanol; nitrogen - docetaxel sandoz is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. docetaxel sandoz in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. docetaxel sandoz in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease. docetaxel sandoz in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. doxorubicin and cyclophosphamide followed by docetaxel sandoz in combination with trastuzumab (ac-th) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel sandoz in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of =1cm and < 7cm. docetaxel sandoz is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy. docetaxel sandoz is indicated for the treatment of metastatic carcinoma of the ovary after failure of firstline or subsequent chemotherapy. docetaxel sandoz is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. docetaxel sandoz, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

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

sandoz pty ltd - pravastatin sodium, quantity: 20 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; colloidal anhydrous silica; dibasic sodium phosphate; croscarmellose sodium; povidone; lactose monohydrate; iron oxide red; magnesium stearate - as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/l) serum cholesterol levels. patients with unstable angina pectoris (see clinical trials). as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).

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

sandoz pty ltd - pravastatin sodium, quantity: 80 mg - tablet - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; povidone; sodium lauryl sulfate; dibasic sodium phosphate; croscarmellose sodium; magnesium stearate; iron oxide red; lactose monohydrate - as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/l) serum cholesterol levels. patients with unstable angina pectoris (see clinical trials). as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).