European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - docetaxel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - antineoplastic agents - treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tenofovir disoproxil - hiv infections - antivirals for systemic use - hiv-1 infectiontenofovir disoproxil 245 mg film-coated tablets are 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 245 mg film-coated tablets are also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.the choice of tenofovir disoproxil 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 245 mg film-coated tablets are 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.evidence of lamivudine-resistant hepatitis b virus.decompensated liver disease.tenofovir disoproxil 245 mg film-coated tablets are 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.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - zonisamide - epilepsy - antiepileptics, - monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.

European Union - English - 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

European Union - English - 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.

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - fulvestrant - breast neoplasms - endocrine therapy - fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on antiestrogen therapy.

European Union - English - 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).

European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - rasagiline tartrate - parkinson disease - anti-parkinson drugs - rasagiline mylan is indicated for the treatment of idiopathic parkinson’s disease (pd) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

European Union - English - 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. 

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuscular blockade - all other therapeutic products - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults.for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.