European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - zoledronic acid - fractures, bone - drugs for treatment of bone diseases - prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone;treatment of adult patients with tumour-induced hypercalcaemia (tih).

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 - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - antithrombotic agents - clopidogrel/acetylsalicylic acid mylan is indicated for the secondary prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (asa).clopidogrel/acetylsalicylic acid mylan is a fixed-dose combination medicinal product for continuation of therapy in:non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary interventionst segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - abiraterone acetate - prostatic neoplasms - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt).the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

European Union - English - 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.

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 s.a.s - ribavirin - hepatitis c, chronic - antivirals for systemic use - ribavirin mylan is indicated for the treatment of chronic hepatitis c and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (three years of age and older) and adolescents). ribavirin monotherapy must not be used.there is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e. not alfa-2b).please refer also to the interferon alfa-2b summary of product characteristics (smpc) for prescribing information particular to that product.naïve patientsadult patientsribavirin mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (alt), who are positive for serum hepatitis-c-virus (hcv) rna.children and adolescentsribavirin mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents three years of age and older, who have all types of chronic hepatitis c except genotype 1, not previously treated, without liver decompensation, and who are positive for serum hcv rna. when deciding to not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case-by-case basis (see section 4.4).previously treatment-failure patientsadult patientsribavirin mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis c who have previously responded (with normalisation of alt at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.

Canada - English - Health Canada

mylan pharmaceuticals ulc - hydroxyurea - capsule - 500mg - hydroxyurea 500mg - antineoplastic agents

Canada - English - Health Canada

mylan pharmaceuticals ulc - pantoprazole (pantoprazole sodium sesquihydrate) - tablet (delayed-release) - 40mg - pantoprazole (pantoprazole sodium sesquihydrate) 40mg - proton-pump inhibitors

European Union - English - EMA (European Medicines Agency)

mylan s.a.s - ambrisentan - hypertension, pulmonary - antihypertensives, - ambrisentan mylan is indicated for the treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment. efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease.ambrisentan mylan is indicated for the treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment. efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease.