Malta - engleză - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sunitinib - hard capsule - sunitinib 12.5 mg - antineoplastic agents

Malta - engleză - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sunitinib - hard capsule - sunitinib 25 mg - antineoplastic agents

Malta - engleză - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sunitinib - hard capsule - sunitinib 37.5 mg - antineoplastic agents

Malta - engleză - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - sunitinib - hard capsule - sunitinib 50 mg - antineoplastic agents

Malaezia - engleză - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

mylan healthcare sdn. bhd. - etoposide -

Malaezia - engleză - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

mylan healthcare sdn. bhd. - ondansetron hydrochloride dihydrate -

Uniunea Europeană - engleză - 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.

Uniunea Europeană - engleză - 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.

Uniunea Europeană - engleză - 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.

Uniunea Europeană - engleză - 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.