Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - rasagilintartrat - parkinsons sygdom - anti-parkinson-lægemidler - rasagilin mylan er indiceret til behandling af idiopatisk parkinsons sygdom (pd) som monoterapi (uden levodopa) eller som supplerende behandling (med levodopa) hos patienter med afslutning af dosisudsving.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - amlodipin besilate, valsartan - forhøjet blodtryk - agenter, der virker på renin-angiotensinsystemet - behandling af essentiel hypertension. amlodipin/valsartan mylan er indiceret hos voksne, hvis blodtryk ikke er tilstrækkeligt kontrolleret på amlodipin eller valsartan monoterapi.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tadalafil - erektil dysfunktion - urologicals - behandling af erektil dysfunktion hos voksne mænd. for at tadalafil skal være effektiv, kræves seksuel stimulation. tadalafil mylan er ikke indiceret til brug hos kvinder.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multipel sklerose, recidiverende-remitterende - immunosuppressiva - 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).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan ireland limited - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiske midler - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan ireland limited - arsen trioxid - leukæmi, promyelocytisk, akut - antineoplastiske midler - arsen trioxid mylan er indiceret til induktion af remission, og en konsolidering i voksne patienter med:- nydiagnosticerede lav til intermediær risiko for akut promyelocyt leukæmi (apl) (hvide blodlegemer, ≤ 10 x 103/µl) i kombination med trans-retinsyre (atra)- recidiverende/refraktær akut promyelocyt leukæmi (apl) (tidligere behandling burde have medtaget en retinoid og kemoterapi), der er karakteriseret ved tilstedeværelsen af t(15;17) translokation og/eller tilstedeværelsen af promyelocyt leukæmi/retinsyre receptor alpha (pml/rar-alpha) - genet. svarprocenten af anden akut myeloid leukæmi undertyper til arsen trioxid har ikke beenexamined.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan ireland limited - lenalidomid - multipelt myelom - immunosuppressiva - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan ireland limited - abiraterone acetat - prostatiske neoplasmer - 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazol - schizophrenia; bipolar disorder - psykoleptika - aripiprazol mylan pharma er indiceret til behandling af skizofreni hos voksne og hos unge i alderen 15 år og ældre. aripiprazol mylan pharma er indiceret til behandling af moderate til svære maniske episoder i bipolar lidelse og til forebyggelse af nye maniske episode i voksne, der har oplevet overvejende maniske episoder og hvis maniske episoder svarede, at aripiprazol-behandling. aripiprazol mylan pharma er indiceret til behandling i op til 12 uger af moderate til svære maniske episoder i bipolar jeg uorden i unge i alderen 13 år og ældre.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - cinacalcethydrochlorid - hyperparathyroidism, secondary; hypercalcemia - calciumhomeostase - behandling af sekundær hyperparathyroidisme (hpt) hos patienter med nyresygdom i sluttrinnet (esrd) ved vedligeholdelsesdialysebehandling. cinacalcet mylan kan bruges som en del af en terapeutiske regime inklusive fosfat bindemidler og/eller vitamin d steroler, som er relevant. reduktion af hypercalcaemia i patienter med:parathyroid carcinomaprimary hpt, for hvem parathyroidectomywould være angivet på grundlag af serum calcium-niveauer (som defineret i de relevante retningslinjer for behandling), men i hvem parathyroidectomy ikke er klinisk relevant, eller er kontraindiceret.