ESTO 15 Israel - English - Ministry of Health

esto 15

unipharm ltd, israel - escitalopram as oxalate - film coated tablets - escitalopram as oxalate 15 mg - escitalopram - treatment of depression and panic disorder. treatment of generalized anxiety disorder (gad), treatment of social anxiety disorder (social phobia). treatment of obsessive compulsive disorder.

DRONCOR Israel - English - Ministry of Health

droncor

unipharm ltd, israel - dronedarone as hydrochloride - coated tablets - dronedarone as hydrochloride 400 mg - dronedarone - droncor is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (af). due to its safety profile, droncor should only be prescribed after alternative treatment options have been considered. droncor should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.

ATOMIC 100 Israel - English - Ministry of Health

atomic 100

unipharm ltd, israel - atomoxetine as hydrochloride - coated tablets - atomoxetine as hydrochloride 100 mg - atomoxetine - atomic is indicated for the treatment of attention-deficit/hyperactivity disorder (adhd) in children of 6 years and older, in adolescents and in adults as part of a comprehensive treatment programme. treatment must be initiated by a specialist in the treatment of adhd, such as a paediatrician, child/adolescent psychiatrist, or psychiatrist. diagnosis should be made according to current dsm criteria or the guidelines in icd. in adults, the presence of symptoms of adhd that were pre-existing in childhood should be confirmed. third-party corroboration is desirable and atomic should not be initiated when the verification of childhood adhd symptoms is uncertain. diagnosis cannot be made solely on the presence of one or more symptoms of adhd.based on clinical judgment, patients should have adhd of at least moderate severity as indicated by at least moderate functional impairment in 2 or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual’s life.

ATOMIC 18 Israel - English - Ministry of Health

atomic 18

unipharm ltd, israel - atomoxetine as hydrochloride - coated tablets - atomoxetine as hydrochloride 18 mg - atomoxetine - atomic is indicated for the treatment of attention-deficit/hyperactivity disorder (adhd) in children of 6 years and older, in adolescents and in adults as part of a comprehensive treatment programme. treatment must be initiated by a specialist in the treatment of adhd, such as a paediatrician, child/adolescent psychiatrist, or psychiatrist. diagnosis should be made according to current dsm criteria or the guidelines in icd. in adults, the presence of symptoms of adhd that were pre-existing in childhood should be confirmed. third-party corroboration is desirable and atomic should not be initiated when the verification of childhood adhd symptoms is uncertain. diagnosis cannot be made solely on the presence of one or more symptoms of adhd.based on clinical judgment, patients should have adhd of at least moderate severity as indicated by at least moderate functional impairment in 2 or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual’s life.

ATOMIC 80 Israel - English - Ministry of Health

atomic 80

unipharm ltd, israel - atomoxetine as hydrochloride - coated tablets - atomoxetine as hydrochloride 80 mg - atomoxetine - atomic is indicated for the treatment of attention-deficit/hyperactivity disorder (adhd) in children of 6 years and older, in adolescents and in adults as part of a comprehensive treatment programme. treatment must be initiated by a specialist in the treatment of adhd, such as a paediatrician, child/adolescent psychiatrist, or psychiatrist. diagnosis should be made according to current dsm criteria or the guidelines in icd. in adults, the presence of symptoms of adhd that were pre-existing in childhood should be confirmed. third-party corroboration is desirable and atomic should not be initiated when the verification of childhood adhd symptoms is uncertain. diagnosis cannot be made solely on the presence of one or more symptoms of adhd.based on clinical judgment, patients should have adhd of at least moderate severity as indicated by at least moderate functional impairment in 2 or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual’s life.

TORVA 80 Israel - English - Ministry of Health

torva 80

unipharm ltd, israel - atorvastatin as calcium trihydrate - coated tablets - atorvastatin as calcium trihydrate 80 mg - atorvastatin - torva is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. torva is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable.pediatric patients (10-17 years of age) : torva is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient.prevention of cardiovascular and/or cerebrovascular event such as mi or stroke: as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor.in patients with clinically evident coronary heart disease torva is indicated to:reduce the risk of non-fatal myocardial infarction.reduce the risk of fatal and non fatal stroke.reduce the risk for revascularization procedures.reduce the risk of hospitalization for chf.reduce the risk of angina.

RISPOND SOLUTION Israel - English - Ministry of Health

rispond solution

unipharm ltd, israel - risperidone - solution - risperidone 1 mg/ml - risperidone - rispond is indicated for the management of schizophrania and manifestation of psychotic disorders. the antipsychotic efficacy of rispond was established in short-term (6 to 8 weeks) controlled trials of schizophrenic inpatients. rispond is also effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. rispond is indicated for the treatment of psychotic manifestations of dementia. conduct and other disruptive disorders: treatment of behavioral disorders expressed by impulse control disorders or self-alienated-aggressive or treatment- requiring behavioral disorders with reduced or substandard intelligence. treatment should not be given to children under the age of 5 years. rispond is indicated for the treatment of mania in bipolar disorder. these episodes are characterized by symptoms such as elevated expansive or irritable mood inflated self-esteem decreased need for sleep pressured speech racing thoughts distractibility or poor judgment including disruptibe or aggressive behaviors.

PIRON 267  Israel - English - Ministry of Health

piron 267

unipharm ltd, israel - pirfenidone - tablets - pirfenidone 267 mg - pirfenidone - piron is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf)

PIRON 801  Israel - English - Ministry of Health

piron 801

unipharm ltd, israel - pirfenidone - tablets - pirfenidone 801 mg - pirfenidone - piron is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf)

GASTRO 20 Israel - English - Ministry of Health

gastro 20

unipharm ltd, israel - famotidine - tablets - famotidine 20 mg - famotidine - for the treatment and prevention of heart burn and hyperacidity in the upper gastrointestinal tract.