Европска Унија - Енглески - EMA (European Medicines Agency)

mylan pharmaceuticals limited - anagrelide hydrochloride - thrombocythemia, essential - antineoplastic agents - anagrelide is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (et) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.an at-risk patientan at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events. 

Европска Унија - Енглески - 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).

Малезија - Енглески - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

mylan healthcare sdn. bhd. - epirubicin hydrochloride -

Малта - Енглески - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pantoprazole - gastro-resistant tablet - pantoprazole 20 mg - drugs for acid related disorders

Малта - Енглески - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pantoprazole - gastro-resistant tablet - pantoprazole 40 mg - drugs for acid related disorders

Малта - Енглески - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - tigecycline - powder for solution for infusion - tigecycline 50 mg - antibacterials for systemic use

Европска Унија - Енглески - EMA (European Medicines Agency)

mylan s.a.s. - lopinavir/ritonavir - hiv infections - antivirals for systemic use, - lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infected adults, adolescents and children above the age of 2 years.the choice of lopinavir/ritonavir to treat protease inhibitor experienced hiv-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

Европска Унија - Енглески - EMA (European Medicines Agency)

mylan ireland limited - lenalidomide - multiple myeloma - immunosuppressants - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

Европска Унија - Енглески - 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. 

Европска Унија - Енглески - 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.