Europäische Union - Maltesisch - EMA (European Medicines Agency)

biomarin international limited - cerliponase alfa - ceroid-lipofuscinoses newronali - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - brineura huwa indikat għall-kura ta newronali ceroid lipofuscinosis tat-tip 2 (cln2) il-marda, magħrufa wkoll bħala tripeptidyl peptidase 1 (tpp1), defiċjenza.

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)

fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - il-prodotti terapewtiċi l-oħra kollha - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

biomarin international limited - galsulfase - mucopolysaccharidosis vi - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - naglazyme huwa indikat għal terapija s-sostituzzjoni ta ' l-enżima fit-tul fil-pazjenti bl-djanjosi konfermati ta ' mucopolysaccharidosis vi (mps vi; defiċjenza n-acetylgalactosamine-4-sulfatase; maroteaux-lamy syndrome) (ara taqsima 5. kif għall-lisosomali disturbi ġenetiċi, huwa ta'importanza primarja, speċjalment fil-forom severi, li tinbeda l-kura malajr kemm jista 'jkun, qabel id-dehra ta jitfaċċaw manifestazzjonijiet kliniċi mhux reversibbli ta' l-mard. punt kruċjali huwa li tikkura pazjenti żgħar li għandhom bejn.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

glaxosmithkline trading services limited - fluticasone furoate, bromur tal-umeclidinium, trifenatate tal-vilanterol - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - elebrato ellipta hija indikata bħala trattament manutenzjoni fil-pazjenti adulti ma moderat severi kronika eliminat pulmonari marda (copd) li m'humiex ittrattati adegwatament mill-għaqda tal-corticosteroid bin-nifs u a twila u jaġixxu β2-agonist.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

merck europe b.v. - avelumab - tumuri newroentokrini - aġenti antineoplastiċi oħra, antikorpi monoklonali - bavencio huwa indikat bħala monoterapija għat-trattament ta 'pazjenti adulti b'karċinoma metastatika taċ-ċellula ta' merkel (mcc). bavencio flimkien ma aksitinib huwa indikat għall-kura tal-ewwel linja ta ' pazjenti adulti b'karċinoma taċ-ċellola renali (rcc). bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc) who are progression-free following platinum‑based chemotherapy.

Europäische Union - Maltesisch - 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.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

novartis europharm limited  - brolucizumab - deġenerazzjoni makulari mxarrba - oftalmoloġiċi - beovu huwa indikat fl-adulti għall-kura ta neovaskulari (imxarrba) relatata mal-età deġenerazzjoni makulari (amd).

Europäische Union - Maltesisch - EMA (European Medicines Agency)

mylan pharmaceuticals limited - memantina idrokloridu - marda ta 'alzheimer - other anti-dementia drugs, psychoanaleptics, - trattament ta 'pazjenti b'mard ta' alzheimer moderat għal sever.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

novartis europharm limited - basiliximab - graft rejection; kidney transplantation - immunosoppressanti - simulect huwa indikat għall-profilassi tar-rifjut tal-organu akut fit-trapjant renali alloġeniku de-novo f'pazjenti adulti u pedjatriċi (1-17-il sena). huwa jintuża flimkien ma 'ciclosporin għal mikroemulsjoni u kortikosterojdi bbażati fuq l-immunosoppressjoni, fil-pazjenti bil-panel reattiv ta' antikorpi inqas minn 80%, jew fil-triplu tal-manteniment ta 'terapija ta' jkun fiha ciclosporin għal mikroemulsjoni, kortikosterojdi, u jew azathioprine jew mycophenolate mofetil.