European Union - English - 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.

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 - 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 - 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. 

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).

Malta - English - 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

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 pharmaceuticals limited - teriflunomide - multiple sclerosis, relapsing-remitting - immunosuppressants - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5.1 of the smpc for important information on the population for which efficacy has been established). 

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - atazanavir (as sulfate) - hiv infections - antivirals for systemic use - atazanavir mylan, co-administered with low dose ritonavir, is indicated for the treatment of hiv 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 pi mutations). there are very limited data available from children aged 6 to less than 18 years.the choice of atazanavir mylan in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.