Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan pharmaceuticals limited - efavirenz, emtricitabine, tenofovir disoproxil maleate - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - efavirenz / emtricitabine / tenofovir disoproxil mylan huwa kombinazzjoni ta 'doża fissa ta' efavirenz, emtricitabine u tenofovir disoproxil. dan huwa indikat għat-trattament ta ' l-infezzjoni tal-virus ta ' immunodefiċjenza umani-1 (hiv-1) fl-adulti età ta ' 18-il sena u aktar ma virologic it-trażżin għall-hiv-1 rna livelli ta ' < 50 kopji/ml fuq tagħhom terapija kurrenti antiretroviral ta ' l-għaqda għal aktar minn tliet xhur. pazjenti għandu ma esperjenzaw nuqqas viroloġika fuq xi terapija antiretroviral minn qabel u għandhom ikunu magħrufa li ma jkunu harboured ir-razez tal-virus bl-mutazzjonijiet li jikkonferixxu reżistenza sinifikanti lil xi tat-tliet komponenti li jinsabu fil-efavirenz / emtricitabine/tenofovir disoproxil mylan qabel il-bidu ta ' l-ewwel skoperta ta ' trattament ta ' antiretroviral. id-dimostrazzjoni tal-benefiċċju ta 'efavirenz/emtricitabine/tenofovir disoproxil huwa bbażat primarjament fuq dejta minn 48 ġimgħa minn studju kliniku li fih il-pazjenti b'soppressjoni viroloġika stabbli fuq terapija antiretrovirali ta' kombinazzjoni bidlu għal efavirenz/emtricitabine/tenofovir disoproxil (ara sezzjoni 5. bħalissa m'hemm l-ebda dejta disponibbli minn studji kliniċi b'efavirenz / emtricitabine / tenofovir disoproxil f'pazjenti li qatt ma ħadu kura jew f'pazjenti ttrattati bil-kbir. ebda dejta ma hija disponibbli biex tappoġġja l-kumbinazzjoni ta ' efavirenz/emtricitabine/tenofovir disoproxil u aġenti antiretrovirali oħra.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan pharmaceuticals limited - fulvestrant - neoplażmi tas-sider - terapija endokrinali - fulvestrant huwa indikat għall-kura ta ' pożittiv għar-riċetturi tal-estroġenu, lokalment avvanzat jew tal-kanċer tas-sider metastatiku fin-nisa wara l-menopawża:ma kinux ittrattati qabel b'terapija endokrinali, orwith rikaduta tal-marda fuq jew wara l-adjuvant kontra l-estroġenu-terapija, jew progressjoni tal-marda fuq antiestrogen-terapija.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - aġenti antitrombotiċi - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan ireland limited - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - aġenti antineoplastiċi - 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.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan s.a.s - ritonavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - ritonavir huwa indikat flimkien ma 'aġenti antiretrovirali oħra għat-trattament ta' pazjenti infettati bl-hiv 1 (adulti u tfal ta '2 snin u aktar).

Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan ireland limited - lenalidomide - majloma multipla - immunosoppressanti - 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).

Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan pharmaceuticals limited - cinacalcet hydrochloride - hyperparathyroidism, secondary; hypercalcemia - homeostasi tal-kalċju - il-kura ta 'iperparatirojdiżmu sekondarju (hpt) f'pazjenti b'mard renali fl-aħħar stadju (esrd) fuq terapija ta' dijalisi ta 'manteniment. cinacalcet mylan jista 'jintuża bħala parti minn kors terapewtiku li jinkludi binders tal-fosfat u/jew sterols ta' vitamina d, kif xieraq. tnaqqis ta 'iperkalċimja f'pazjenti b': - paratirojde carcinomaprimary hpt li għalihom parathyroidectomywould tkun indikata fuq il-bażi tal-livelli tal-kalċju fis-serum (kif definit mil-linji gwida ta ' kura rilevanti), iżda fejn paratirojdektomija mhiex klinikament xierqa jew kontraindikata.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan s.a.s - ambrisentan - pressjoni għolja, pulmonari - għal pressjoni għolja, - ambrisentan mylan huwa indikat għall-kura tal-pressjoni għolja arterjali pulmonari (pah) f'pazjenti adulti tal-klassi funzjonali tal-who (fc) ii iii, inkluż l-użu fil-kura flimkien. l-effikaċja ntweriet f'aph idjopatika (ipah) u f'pah assoċjata ma 'mard tat-tessut konnettiv. ambrisentan mylan huwa indikat għall-kura tal-pressjoni għolja arterjali pulmonari (pah) f'pazjenti adulti tal-klassi funzjonali tal-who (fc) ii iii, inkluż l-użu fil-kura flimkien. l-effikaċja ntweriet f'aph idjopatika (ipah) u f'pah assoċjata ma 'mard tat-tessut konnettiv.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan pharmaceuticals limited - deferasirox - iron overload; beta-thalassemia - aġenti kelanti tal-ħadid - deferasirox mylan huwa indikat għall-kura ta 'tagħbija żejda kronika tal-ħadid minħabba trasfużjonijiet tad-demm frekwenti (≥7 ml/kg/xahar ta' ċelloli ħomor ippakkjati) f'pazjenti bil-beta talassemija maġġuri ta '6 snin u l-olderthe-trattament tal-eċċess kroniku ta'ħadid minħabba trasfużjonijiet tad-demm meta terapija b'deferoxamine tkun kontra-indikata jew inadegwata f'dawn gruppi ta' pazjenti:f'pazjenti pedjatriċi b'beta-talessimja maġġuri b'tagħbija żejda tal-ħadid minħabba trasfużjonijiet tad-demm frekwenti (≥7 ml/kg/xahar ta ' ċelloli ħomor ippakkjati) b'età minn 2 sa 5 snin,fl-adulti u f'pazjenti pedjatriċi bil-beta talassemija maġġuri b'tagħbija żejda tal-ħadid minħabba trasfużjonijiet tad-demm frekwenti (.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psikolettiċi - aripiprazole mylan pharma huwa indikat għall-kura ta 'l-iskiżofrenja fl-adulti u fl-adoloxxenti li għandhom 15-il sena jew aktar. aripiprazole mylan pharma huwa indikat għat-trattament ta 'episodji manijaċi serji f'disturb bipolari i u għall-prevenzjoni ta' episodju manijaku ġdid f'adulti li esperjenzaw episodji predominantament manijaċi u li l-episodji manijaċi rrispondew għat-trattament b'aripiprazole. aripiprazole mylan pharma huwa indikat għall-kura sa 12-il ġimgħa ta 'episodji manijaċi serji f'disturb bipolari i fl-adolexxenti ta' minn 13-il sena u anzjani.