Malta - English - Medicines Authority

zentiva k.s. u kabelovny 130, dolní mecholupy, 102 37 praha 10, czech republic - atorvastatin - film-coated tablet - atorvastatin 10 mg - lipid modifying agents

Malta - English - Medicines Authority

zentiva k.s. u kabelovny 130, dolní mecholupy, 102 37 praha 10, czech republic - atorvastatin - film-coated tablet - atorvastatin 20 mg - lipid modifying agents

Malta - English - Medicines Authority

zentiva k.s. u kabelovny 130, dolní mecholupy, 102 37 praha 10, czech republic - atorvastatin - film-coated tablet - atorvastatin 40 mg - lipid modifying agents

Malta - English - Medicines Authority

zentiva k.s. u kabelovny 130, dolní mecholupy, 102 37 praha 10, czech republic - atorvastatin - film-coated tablet - atorvastatin 80 mg - lipid modifying agents

European Union - English - EMA (European Medicines Agency)

zentiva, k.s. - duloxetine - neuralgia; depressive disorder, major; anxiety disorders; diabetes mellitus - other antidepressants - treatment depressive disorder, diabetic neuropathic pain, anxiety disorder. duloxetine zentiva is indicated in adults.,

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - irbesartan - 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)

zentiva k.s. - pregabalin - anxiety disorders; neuralgia; epilepsy - antiepileptics, - neuropathic painpregabalin zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults.epilepsypregabalin zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.generalised anxiety disorderpregabalin zentiva k.s. is indicated for the treatment of generalised anxiety disorder (gad) in adults.

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - clopidogrel - stroke; peripheral vascular diseases; myocardial infarction; acute coronary syndrome - antithrombotic agents - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six 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 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 and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke.for further information please refer to section 5.1.

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - leflunomide - arthritis, rheumatoid; arthritis, psoriatic - immunosuppressants - leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard);active psoriatic arthritis.recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

European Union - English - EMA (European Medicines Agency)

zentiva, k.s. - ivabradine hydrochloride - angina pectoris; heart failure - cardiac therapy - symptomatic treatment of chronic stable angina pectoris ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. ivabradine is indicated:in adults unable to tolerate or with a contra-indication to the use of beta-blockersorin combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. treatment of chronic heart failure ivabradine is indicated in chronic heart failure nyha ii to iv class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.