European Union - English - EMA (European Medicines Agency)

bene-arzneimittel gmbh - pentosan polysulfate sodium - cystitis, interstitial - urologicals - elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition.,

European Union - English - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - colesevelam (as hydrochloride) - hypercholesterolemia - lipid modifying agents - cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-a (hmg-coa)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (ldl-c) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and ldl-c in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).

European Union - English - EMA (European Medicines Agency)

dr. friedrich eberth arzneimittel gmbh - lasofoxifene tartrate - osteoporosis, postmenopausal - sex hormones and modulators of the genital system, - fablyn is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1).when determining the choice of fablyn or other therapies, including oestrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).

European Union - English - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated in the treatment of type-2 diabetes mellitus:as monotherapy:in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;as dual oral therapy in combination with:metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;as triple oral therapy in combination with:metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.pioglitazone is also indicated for combination with insulin in type-2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.

European Union - English - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - pioglitazone, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - competact is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.

European Union - English - EMA (European Medicines Agency)

glenmark arzneimittel gmbh - olanzapine - schizophrenia; bipolar disorder - psycholeptics - adultsolanzapine is indicated for the treatment of schizophrenia.olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.olanzapine is indicated for the treatment of moderate to severe manic episode. in patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

European Union - English - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - pioglitazone, glimepiride - diabetes mellitus, type 2 - drugs used in diabetes - tandemact is indicated for the treatment of patients with type-2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.

European Union - English - EMA (European Medicines Agency)

glenmark arzneimittel gmbh - olanzapine - schizophrenia; bipolar disorder - psycholeptics - adultsolanzapine is indicated for the treatment of schizophrenia.olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.olanzapine is indicated for the treatment of moderate to severe manic episode. in patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

European Union - English - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - verteporfin - myopia, degenerative; macular degeneration - ophthalmologicals - visudyne is indicated for the treatment of:adults with exudative (wet) age-related macular degeneration (amd) with predominantly classic subfoveal choroidal neovascularisation (cnv) or;adults with subfoveal choroidal neovascularisation secondary to pathological myopia.

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

smith & nephew pty ltd - 44760 - prosthetic joint facsimile set - a collection of copies of the prostheses to be implanted, comprised of sets of facsimiles matching the final components (e.g., acetabular and femoral components of a hip prosthesis) used to validate the proper size of the permanent prosthesis required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions.