Európai Unió - angol - 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.

Európai Unió - angol - 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.,

Európai Unió - angol - 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.

Európai Unió - angol - EMA (European Medicines Agency)

zentiva k.s. - riluzole - amyotrophic lateral sclerosis - other nervous system drugs - riluzole zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (als).clinical trials have demonstrated that riluzole zentiva extends survival for patients with als. survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.there is no evidence that riluzole zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. riluzole zentiva has not been shown to be effective in the late stages of als.safety and efficacy of riluzole zentiva has only been studied in als. therefore, riluzole zentiva should not be used in patients with any other form of motor-neurone disease.

Európai Unió - angol - 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).

Európai Unió - angol - 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.

Európai Unió - angol - 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.

Európai Unió - angol - 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

Egyesült Királyság - angol - myHealthbox

zentiva - vardenafil - film-coated tablets - 5mg - urologicals, drugs used in erectile dysfunction - treatment of erectile dysfunction in adult men. erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

Egyesült Királyság - angol - myHealthbox

zentiva - vardenafil - film-coated tablets - 10mg - urologicals, drugs used in erectile dysfunction - treatment of erectile dysfunction in adult men. erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.