Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tadalafil - disfunzjoni erettili - uroloġiċi - trattament ta 'disfunzjoni erettili f'annimali adulti. sabiex tadalafil ikun effettiv, l-istimulazzjoni sesswali hija meħtieġa. tadalafil mylan mhuwiex indikat għall-użu min-nisa.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - entecavir monohydrate - epatite b - antivirali għal użu sistemiku - entecavir mylan is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active inflammation and/or fibrosis. mard tal-fwied dekompensat. kemm għall-kkumpensati u mard tal-fwied dikumpensat, din l-indikazzjoni hija bbażata fuq tagħrif minn provi kliniċi f'pazjenti li huma nucleoside naïve b'hbeag pożittiv u hbeag negattiv li jaqbadhom infezzjoni hbv. fir-rigward ta 'pazjenti b'epatite b refrattarja għal lamivudine. entecavir mylan huwa indikat ukoll għat-trattament ta ' infezzjoni hbv kronika nucleoside naïve pazjenti pedjatriċi minn 2 sa.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - febuxostat - hyperuricemia; arthritis, gouty; gout - preparazzjonijiet antigout - febuxostat mylan huwa indikat għall-prevenzjoni u trattament ta ' l-hyperuricaemia fil-pazjenti adulti li għaddejjin minn chemotherapy għal malignancies haematologic f'riskju intermedju għall-għoli tal-tumuri lysis syndrome (tls). febuxostat mylan huwa indikat għat-trattament ta'iperuriċemija kronika f'kundizzjonijiet fejn il-depożizzjoni ta ' urate diġà seħħet (inkluż passat, jew preżenza ta tophus u/jew l-artrite tal-gotta). febuxostat mylan huwa indikat fl-adulti.

Unjoni Ewropea - Malti - 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).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - prasugrel besilate - myocardial infarction; acute coronary syndrome; angina, unstable - aġenti antitrombotiċi - prasugrel mylan, ko-amministrat ma ' acetylsalicylic acid (asa), huwa indikat għall-prevenzjoni ta'avvenimenti aterotrombotiċi f'pazjenti adulti b'sindromu koronarju akut (i. anġina instabbli, mhux tas-segment st 'infart mijokardijaku b'elevazzjoni [ua/nstemi] jew elevazzjoni tas-segment st' infart mijokardijaku [stemi]) li għaddejjin minn primarju jew ittardjat ta ' intervent koronarju perkutaneju (pci).

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - 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 (.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - aġenti antitrombotiċi - clopidogrel/acetylsalicylic acid mylan huwa indikat għall-prevenzjoni sekondarja ta ' avvenimenti aterotrombotiċi f'pazjenti adulti li diġà qed jieħdu ż-żewġ clopidogrel u acetylsalicylic acid (asa). clopidogrel/acetylsalicylic acid mylan huwa kombinazzjoni b'doża fissa tal-prodott mediċinali għall-kontinwazzjoni tat-terapija:mhux elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux-mewġa-q infart mijokardijaku) li jinkludu pazjenti fi proċess li titpoġġa stent wara koronarju perkutanju interventionst elevazzjoni tas-segment infart mijokardijaku akut fil-medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - 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. , terapija ta 'kumbinazzjoni tripla) bħala żieda mad-dieta u l-eżerċizzju f'pazjenti mhux ikkontrollati adegwatament fuq id-doża massima ttollerata ta' metformin u sulphonylurea. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , 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. , 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.