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. - 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. - 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. - 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. - 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. - 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. - docetaxel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; stomach neoplasms; breast neoplasms - antineoplastic agents - breast cancerdocetaxel winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.for patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.docetaxel winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.docetaxel winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent.docetaxel winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease.docetaxel winthrop in combination with capecitabine 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.non-small-cell lung cancerdocetaxel winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.docetaxel winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.prostate cancerdocetaxel winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer.gastric adenocarcinomadocetaxel winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.head and neck cancerdocetaxel winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

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.