Європейський Союз - англійська - EMA (European Medicines Agency)

krka, d.d., novo mesto - repaglinide - diabetes mellitus, type 2 - drugs used in diabetes - repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (niddm)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

Європейський Союз - англійська - EMA (European Medicines Agency)

krka, d.d., novo mesto - febuxostat - hyperuricemia; gout - antigout preparations - febuxostat krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).febuxostat krka is indicated in adults.

Європейський Союз - англійська - EMA (European Medicines Agency)

krka, d.d., novo mesto - efavirenz, emtricitabine, tenofovir disoproxil succinate - hiv infections - antivirals for systemic use - efavirenz/emtricitabine/tenofovir disoproxil krka is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil krka prior to initiation of their first antiretroviral treatment regimen.the demonstration of the benefit of efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil.no data are currently available from clinical studies with efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.no data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

krka d.d. - rasagiline - tablets - 1mg - anti-parkinson drugs, monoamine oxidase b inhibitors - rasagiline krka is indicated for the treatment of idiopathic parkinson’s disease (pd) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - linezolid - film-coated tablet - 600 milligram(s) - other antibacterials; linezolid - antibacterials for systemic use, other antibacterials - linezolid krka is indicated in adults for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible gram positive bacteria. in determining whether linezolid krka is an appropriate treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents among gram positive bacteria should be taken into consideration

Європейський Союз - англійська - EMA (European Medicines Agency)

krka, d.d., novo mesto - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated as second or third line treatment of type 2 diabetes mellitus as described below: as monotherapy- in adult 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- a sulphonylurea, only in adult 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; pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.after initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in hba1c). in patients who fail to show an adequate response, pioglitazone should be discontinued. in light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

Європейський Союз - англійська - EMA (European Medicines Agency)

krka, d.d., novo mesto - clopidogrel (as hydrochloride) - peripheral vascular diseases; stroke; myocardial infarction - antithrombotic agents - clopidogrel is indicated in adults for the prevention of atherothrombotic events in:patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.

Європейський Союз - англійська - EMA (European Medicines Agency)

krka, d.d., novo mesto - clopidogrel (as hydrochloride) - peripheral vascular diseases; stroke; myocardial infarction - antithrombotic agents - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35days), ischaemic stroke (from 7days until less than 6months) or established peripheral arterial disease.adult patients suffering from acute coronary syndrome:non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa).st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy.prevention of atherothrombotic and thromboembolic events in atrial fibrillationin adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke.

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - duloxetine - gastro-resistant capsule, hard - 30 milligram(s) - other antidepressants; duloxetine - psychoanaleptics, other antidepressants - treatment of major depressive disorder. treatment of diabetic peripheral neuropathic pain. treatment of generalised anxiety disorder.

Ірландія - англійська - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - duloxetine - gastro-resistant capsule, hard - 60 milligram(s) - other antidepressants; duloxetine - psychoanaleptics, other antidepressants - treatment of major depressive disorder. treatment of diabetic peripheral neuropathic pain. treatment of generalised anxiety disorder.