Európska únia - maltčina - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - amino acid metaboliżmu, Żbalji inborn - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.

Európska únia - maltčina - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - aġenti antitrombotiċi - prevenzjoni ta ' l-thromboembolism venous (vte) fil-pazjenti adulti li għaddejjin minn elettiva għadma jew irkoppa sostituzzjoni kirurġija. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 for haemodynamically unstable pe patients. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 għall-emodinamikament instabbli pe pazjenti). adultsprevention 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. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment 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. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 u 5. rivaroxaban accord, 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. adultsprevention 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. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment 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.

Európska únia - maltčina - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - aġenti antineoplastiċi - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Európska únia - maltčina - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulin human - diabetes mellitus - drogi użati fid-dijabete - dijabete mellitus fejn huwa meħtieġ it-trattament bl-insulina. insulina bniedem winthrop mgħaġġla huwa wkoll adattat għat-trattament ta ' koma hyperglycaemic u ketoacidosis, kif ukoll għall-kisba minn qabel, intra - u postoperative stabbilizzazzjoni fil-pazjenti bl-diabetes mellitus.

Európska únia - maltčina - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulin human - diabetes mellitus - drogi użati fid-dijabete - dijabete mellitus fejn huwa meħtieġ it-trattament bl-insulina. insuman rapid huwa wkoll adattat għall-kura ta 'koma ipergliċemika u ketoaċidożi, kif ukoll għall-kisba ta' stabilizzazzjoni minn qabel, intra u wara l-operazzjoni f'pazjenti bid-dijabete mellitus.

Európska únia - maltčina - EMA (European Medicines Agency)

immedica pharma ab - glycerol phenylbutyrate - disturbi taċ-Ċiklu ta 'l-urea, inborn - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - ravicti huwa indikat għall-użu bħala terapija aġġuntiva għall-kroniku tal-ġestjoni ta 'pazjenti bil-urea disturbi fiċ-ċiklu (ucds) inklużi n-nuqqasijiet tal-carbamoyl phosphate-synthase-i (cps), ornithine carbamoyltransferase (otc), argininosuccinate synthetase (ass), argininosuccinate lyase (asl), arginase i (arg) u ornithine translocase defiċjenza hyperornithinaemia-iperammonemija homocitrullinuria sindromu (hhh) li ma jistgħux ikunu ġestiti mill-restrizzjoni ta' proteini tad-dieta u/jew l-aċidu amminiku supplimentazzjoni waħdu. ravicti għandhom jiġu użati mal-restrizzjoni ta ' proteini tad-dieta u, f'xi każijiet, supplimenti tad-dieta (e. , amino acids essenzjali, arginine, citrulline, supplimenti ta 'kaloriji mingħajr proteini).

Európska únia - maltčina - EMA (European Medicines Agency)

alexion europe sas - sebelipase alfa - metaboliżmu tal-lipidi, Żbalji inborn - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - kanuma huwa indikat għal terapija ta 'sostituzzjoni ta' enżimi fit-tul (ert) f'pazjenti ta 'etajiet kollha b'defiċjenza ta' lipase ta 'lysosomal acid (lal).

Európska únia - maltčina - EMA (European Medicines Agency)

bracco international b.v. - hexafluworidu tal-kubrit - ultrasonography; echocardiography - midja ta 'kuntrast - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. sonovue hu għall-użu mal-viżjoni bl-ultrasawnd biex itejbu l-echogenicity tad-demm, jew ta ' fluwidi fil-apparat tal-awrina li jirriżulta f'titjib signal to noise ratio. sonovue għandu jintuża biss f'pazjenti fejn l-istudju mingħajr titjib tal-kuntrast ikun inkonklussiv. echocardiographysonovue huwa tal-kuntrast ekokardjografiku transpulmonari għall-użu f'pazjenti adulti b'suspett jew stabbilita mard kardjovaskulari biex jipprovdu opacification tal-kmamar tal-qalb u jsaħħaħ-ventrikolu tax-xellug endocardial-delineazzjoni tal-fruntiera. doppler tal-macrovasculaturesonovue iżid il-preċiżjoni fil-kxif jew l-esklużjoni ta ' anormalitajiet fl-arterji ċerebrali u extracranial karotide jew fl-arterji periferali f'pazjenti adulti billi jtejbu l-doppler signal to noise ratio. sonovue jżid il-kwalità tal-doppler tal-fluss tal-immaġni u l-tul tal-klinikament utli titjib tas-sinjal fl-evalwazzjoni tal-vina portali f'pazjenti adulti. doppler tal-microvasculaturesonovue itejjeb il-wiri tal-vaskularità tal-fwied u fis-sider feriti waqt il-doppler sonography f'pazjenti adulti li jwassal għal karatterizzazzjoni aktar speċifika tal-leżjonijiet. ultrasonografija tal-ħmieġ ta'l-imsaren fl-awrina tractsonovue huwa indikat għall-użu fil-ultrasonografija tal-ħmieġ ta'l-imsaren fl-apparat f'pazjenti pedjatriċi mill-tarbija tat-twelid sa 18-il sena li jiġi lokalizzat vesicoureteral rifluss. għal-limitazzjoni fl-interpretazzjoni ta negattiv urosonography.

Európska únia - maltčina - EMA (European Medicines Agency)

sanofi b.v. - imiglucerase - mard gaucher - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - cerezyme (imiglucerase) huwa indikat għall-użu bħala longterm enżima terapija ta ' sostituzzjoni fil-pazjenti bl-djanjosi konfermat ta ' non-neuronopathic (tip 1) jew neuronopathic kronika (tip 3) mard gaucher li jesebixxu klinikament sinifikanti nonneurological manifestazzjonijiet tal-marda. il-manifestazzjonijiet mhux newroloġiċi tal-marda gaucher jinkludu wieħed jew aktar mill-kondizzjonijiet li ġejjin:anemija wara l-esklużjoni ta 'kawżi oħra, bħal iron deficiencythrombocytopeniabone-marda wara l-esklużjoni ta' kawżi oħra bħal vitamina d deficiencyhepatomegaly jew splenomegalija.

Európska únia - maltčina - EMA (European Medicines Agency)

grunenthal gmbh - allopurinol, lesinurad - gotta - preparazzjonijiet antigout - duzallo huwa indikat fl-adulti għat-trattament ta'l-iperuriċemija fil-gotta pazjenti li ma kisbux-mira tal-uric acid fis-serum livelli b'doża adegwata ta ' allopurinol waħdu.