Европска Унија - Енглески - EMA (European Medicines Agency)

mylan pharmaceuticals limited - amlodipine besilate, valsartan - hypertension - agents acting on the renin-angiotensin system - treatment of essential hypertension.amlodipine/valsartan mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Европска Унија - Енглески - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole mylan pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole mylan pharma is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.aripiprazole mylan pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.

Европска Унија - Енглески - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv infections - antivirals for systemic use - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4.2).darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):for the treatment of hiv-1 infection in antiretroviral treatment (art)-experienced adult patients, including those that have been highly pre-treated.for the treatment of hiv-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.in deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection. darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2). darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.2). art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. in deciding to initiate treatment with darunavir in such art-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).

Европска Унија - Енглески - EMA (European Medicines Agency)

mylan pharmaceuticals limited - emtricitabine, tenofovir disoproxil maleate - hiv infections - antivirals for systemic use - treatment of hiv-1 infection:emtricitabine/tenofovir disoproxil mylan is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults (see section 5.1).emtricitabine/tenofovir disoproxil mylan is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1).pre-exposure prophylaxis (prep):emtricitabine/tenofovir disoproxil mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).

Европска Унија - Енглески - 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.

Европска Унија - Енглески - EMA (European Medicines Agency)

mylan ireland limited - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide mylan is indicated for induction of remission, and consolidation in adult patients with:- newly diagnosed low to intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 103/μl) in combination with all trans retinoic acid (atra)- relapsed/refractory acute promyelocytic leukaemia (apl) (previous treatment should have included a retinoid and chemotherapy)characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic acid receptor alpha (pml/rar alpha) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not beenexamined.

Европска Унија - Енглески - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.sitagliptin/metformin hydrochloride mylan is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist.sitagliptin/metformin hydrochloride mylan is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Европска Унија - Енглески - EMA (European Medicines Agency)

mylan ireland limited - dimethyl fumarate - multiple sclerosis, relapsing-remitting - immunosuppressants - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Европска Унија - Енглески - 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.

Европска Унија - Енглески - EMA (European Medicines Agency)

mylan pharmaceuticals limited - cinacalcet hydrochloride - hyperparathyroidism, secondary; hypercalcemia - calcium homeostasis - treatment of secondary hyperparathyroidism (hpt) in patients with end-stage renal disease (esrd) on maintenance dialysis therapy.cinacalcet mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate.reduction of hypercalcaemia in patients with:parathyroid carcinomaprimary hpt for whom parathyroidectomywould be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.