Australie - anglais - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - azathioprine, quantity: 25 mg - tablet, film coated - excipient ingredients: purified talc; lactose monohydrate; magnesium stearate; maize starch; povidone; colloidal anhydrous silica; titanium dioxide; hypromellose; microcrystalline cellulose; peg-8 stearate - immunosuppressant antimetabolite: either alone, or more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with higher dosage and prolonged usage of corticosteroids. azathioprine, in combination with cortocosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. azathioprine, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering from the following: severe rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis/polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic anaemia, chronic refractory idiopathic thrombocytopenic purpura.

Irlande - anglais - HPRA (Health Products Regulatory Authority)

sanofi-aventis ireland limited t/a sanofi - mepyramine maleate - cream - 2 percent weight/weight - antihistamines for topical use; mepyramine

Union européenne - anglais - 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.,

Union européenne - anglais - EMA (European Medicines Agency)

sandoz gmbh - ibandronic acid - breast neoplasms; neoplasm metastasis; fractures, bone - drugs for treatment of bone diseases, bisphosphonates - ibandronic acid sandoz is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.,

Union européenne - anglais - EMA (European Medicines Agency)

sandoz gmbh - pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesothelioma pemetrexed sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer pemetrexed sandoz in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed sandoz is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,

Union européenne - anglais - 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.

Union européenne - anglais - 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.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - fingolimod hydrochloride, quantity: 0.56 mg (equivalent: fingolimod, qty 0.5 mg) - capsule, hard - excipient ingredients: mannitol; iron oxide yellow; magnesium stearate; gelatin; titanium dioxide - fingolimod sandoz is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - fenofibrate, quantity: 145 mg - tablet, film coated - excipient ingredients: sodium lauryl sulfate; lactose monohydrate; hypromellose; magnesium stearate; croscarmellose sodium; sucrose; microcrystalline cellulose; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin - fenofibrate sandoz is indicated as an adjunct to diet in the treatment of: - hypercholesterolaemia; - types ii, iii, iv and v dyslipidaemia; - dyslipidaemia associated with type 2 diabetes. fenofibrate sandoz is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. fenofibrate sandoz does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - buprenorphine, quantity: 5 mg - drug delivery system, transdermal - excipient ingredients: levulinic acid; oleyl oleate; povidone; polyethylene; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; acrylates copolymer; ethylene distearamide; adipic acid/1,4-butanediol/mdi copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate - buprenorphine sandoz patches are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. buprenorphine sandoz patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. buprenorphine sandoz patches are not indicated as an as-needed (prn) analgesia.