European Union - English - EMA (European Medicines Agency)

zentiva, k.s. - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole zentiva is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.aripiprazole zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.

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. - 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. - pregabalin - anxiety disorders; epilepsy - antiepileptics, - neuropathic pain , pregabalin zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. , epilepsy , pregabalin zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. , generalised anxiety disorder , pregabalin zentiva 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. - emtricitabine, tenofovir disoproxil phosphate - hiv infections - antivirals for systemic use - treatment of hiv-1 infectionemtricitabine/tenofovir disoproxil zentiva is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults.emtricitabine/tenofovir disoproxil zentiva is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents.pre-exposure prophylaxis (prep)emtricitabine/tenofovir disoproxil zentiva is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults and adolescents at high risk.

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.

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - tenofovir disoproxil phosphate - hiv infections - antivirals for systemic use - hiv‑1 infectiontenofovir disoproxil zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of hiv‑1 infected adults.in adults, the demonstration of the benefit of tenofovir disoproxil in hiv‑1 infection is based on results of one study in treatment‑naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre‑treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).tenofovir disoproxil zentiva is also indicated for the treatment of hiv‑1 infected adolescents, with nrti (nucleotide reverse transcriptase inhibitor) resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.the choice of tenofovir disoproxil zentiva to treat antiretroviral‑experienced patients with hiv‑1 infection should be based on individual viral resistance testing and/or treatment history of patients.hepatitis b infectiontenofovir disoproxil zentiva is indicated for the treatment of chronic hepatitis b in adults with:compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1);evidence of lamivudine-resistant hepatitis b virus (see sections 4.8 and 5.1);decompensated liver disease (see sections 4.4, 4.8 and 5.1).tenofovir disoproxil zentiva is indicated for the treatment of chronic hepatitis b in adolescents 12 to < 18 years of age with:compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum alt levels and histological evidence of active inflammation and/or fibrosis (see sections 4.4, 4.8 and 5.1).

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva 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 zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination 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 efavir

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.