Unia Europejska - angielski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv infections - antivirals for systemic use - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4.2).darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):for the treatment of hiv-1 infection in antiretroviral treatment (art)-experienced adult patients, including those that have been highly pre-treated.for the treatment of hiv-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.in deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection. darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2). darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.2). art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. in deciding to initiate treatment with darunavir in such art-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).

Unia Europejska - angielski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - duloxetine - neuralgia; diabetic neuropathies; depressive disorder, major; anxiety disorders - psychoanaleptics, - treatment of major depressive disorder;treatment of diabetic peripheral neuropathic pain;treatment of generalised anxiety disorder;duloxetine mylan is indicated in adults.

Unia Europejska - angielski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - memantine hydrochloride - alzheimer disease - other anti-dementia drugs, psychoanaleptics, - treatment of patients with moderate to severe alzheimer’s disease.

Unia Europejska - angielski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - olanzapine - schizophrenia; bipolar disorder - psycholeptics - adultsolanzapine is indicated for the treatment of schizophrenia.olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.olanzapine is indicated for the treatment of moderate to severe manic episode.in patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

Unia Europejska - angielski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tadalafil - erectile dysfunction - urologicals - treatment of erectile dysfunction in adult males.in order for tadalafil to be effective, sexual stimulation is required.tadalafil mylan is not indicated for use by women.

Unia Europejska - angielski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - entecavir monohydrate - hepatitis b - antivirals for systemic use - entecavir mylan is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis.decompensated liver disease.for both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with hbeag positive and hbeag negative hbv infection. with respect to patients with lamivudine-refractory hepatitis b.entecavir mylan is also indicated for the treatment of chronic hbv infection in nucleoside naive paediatric patients from 2 to

Unia Europejska - angielski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - febuxostat - hyperuricemia; arthritis, gouty; gout - antigout preparations - febuxostat mylan is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (tls).febuxostat mylan is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).febuxostat mylan is indicated in adults.

Unia Europejska - angielski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - prasugrel besilate - myocardial infarction; acute coronary syndrome; angina, unstable - antithrombotic agents - prasugrel mylan, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-st segment elevation myocardial infarction [ua/nstemi] or st segment elevation myocardial infarction [stemi]) undergoing primary or delayed percutaneous coronary intervention (pci).

Unia Europejska - angielski - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antithrombotic agents - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers. rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery. treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults.-------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment. 

Unia Europejska - angielski - EMA (European Medicines Agency)

mylan ireland limited - dimethyl fumarate - multiple sclerosis, relapsing-remitting - immunosuppressants - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.