European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - capecitabine - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastic agents - ecansya is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.ecansya is indicated for the treatment of metastatic colorectal cancer.ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.ecansya in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline. ecansya is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - irbesartan hydrochloride - hypertension - agents acting on the renin-angiotensin system - treatment of essential hypertension.treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto  - telmisartan - hypertension - angiotensin ii antagonists, plain - hypertensiontreatment of essential hypertension in adults.cardiovascular preventionreduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - clopidogrel (as hydrogen sulfate) - peripheral vascular diseases; stroke; acute coronary syndrome; myocardial infarction - antithrombotic agents - prevention secondary prevention of atherothrombotic events clopidogrel is indicated in:adult 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.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 fibrillation:- in 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.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - rivastigmine - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - symptomatic treatment of mild to moderately severe alzheimer's dementia. symptomatic treatment of mild to moderately severe dementia in patients with idiopathic parkinson's disease.,

European Union - English - EMA (European Medicines Agency)

krka d.d. - pemetrexed disodium - carcinoma, non-small-cell lung; mesothelioma - antineoplastic agents - malignant pleural mesotheliomapemetrexed krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.non-small cell lung cancerpemetrexed krka 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 krka 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 krka 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.

European Union - English - 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. repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone.treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

European Union - English - EMA (European Medicines Agency)

krka, d.d. - memantine hydrochloride - alzheimer disease - other anti-dementia drugs - treatment of patients with moderate to severe alzheimer’s disease.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - telmisartan, hydrochlorothiazide - hypertension - telmisartan and diuretics - tolucombi fixed-dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on tolucombi 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

European Union - English - EMA (European Medicines Agency)

krka, d.d., novo mesto - irbesartan, hydrochlorothiazide - hypertension - agents acting on the renin-angiotensin system - treatment of essential hypertension. this fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.