Den europeiske union - engelsk - 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.

Den europeiske union - engelsk - 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.

Den europeiske union - engelsk - 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.

Den europeiske union - engelsk - 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.

Den europeiske union - engelsk - 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.

Den europeiske union - engelsk - 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.

Den europeiske union - engelsk - 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).

Den europeiske union - engelsk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - gefitinib - carcinoma, non-small-cell lung - antineoplastic agents, protein kinase inhibitors - gefitinib mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (nsclc) with activating mutations of egfr‑tk.

Den europeiske union - engelsk - 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.

Malta - engelsk - Malta 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