Elonva Kesatuan Eropah - Malta - EMA (European Medicines Agency)

elonva

n.v. organon - corifollitropin alfa - reproductive techniques, assisted; ovulation induction; investigative techniques - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - controlled ovarian stimulation (cos) in combination with a gnrh antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (art) program. elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human chorionic gonadotropin (hcg).

Entyvio Kesatuan Eropah - Malta - EMA (European Medicines Agency)

entyvio

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - immunosuppressanti selettivi - kolite colitisentyvio huwa indikat għall-kura ta ' pazjenti adulti b'attiva minn moderata sa gravi kolite bl-ulċeri li kellhom rispons inadegwat b', tilfu r-rispons għal, jew li kienu intolleranti jew terapija konvenzjonali jew fattur tan-nekrożi tat-tumur alfa (tnfa) antagonist. crohn diseaseentyvio huwa indikat għall-kura ta 'pazjenti adulti b'attiva minn moderata sa gravi marda ta' crohn li kellhom rispons inadegwat b', tilfu r-rispons għal, jew li kienu intolleranti jew terapija konvenzjonali jew fattur tan-nekrożi tat-tumur alfa (tnfa) antagonist. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Januvia Kesatuan Eropah - Malta - EMA (European Medicines Agency)

januvia

merck sharp and dohme b.v - sitagliptin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - għall-pazjenti adulti b'dijabete tat-tip 2 mellitus, januvia huwa indikat biex itejbu l-kontroll gliċemiku:bħala monoterapija:f'pazjenti li mhumiex ikkontrollati biżżejjed bid-dieta u l-eżerċizzju waħidhom u li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intolleranza;bħala terapija dupliċi orali flimkien mal:metformin meta d-dieta u l-eżerċizzju flimkien ma 'metformin waħdu ma jipprovdux kontroll gliċemiku adegwat;sulphonylurea meta d-dieta u l-eżerċizzju flimkien ma' doża massima tollerata ta ' sulphonylurea waħedhom ma jipprovdux kontroll gliċemiku adegwat u meta metformin ma jkunx adegwat minħabba kontraindikazzjonijiet jew intolleranza;a peroxisome-proliferator-activated-riċettur gamma (ppary) agonist (i. thiazolidinedione) meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma ' l-agonist ppary waħdu ma jipprovdux kontroll gliċemiku adegwat;ppary agonist (i. thiazolidinedione) meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma 'l-agonist ppary waħdu ma jipprovdux kontroll gliċemiku adegwat;bħala terapija trippla orali f'kombinazzjoni ma': sulphonylurea u metformin meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat;ppary agonista u metformin meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat. januvia huwa wkoll indikat bħala żieda mal-insulina (bil-metformina jew mingħajrha) meta d-dieta u l-eżerċizzju flimkien ma doża stabbli ta ' l-insulina ma jipprovdux kontroll gliċemiku adegwat.

Victrelis Kesatuan Eropah - Malta - EMA (European Medicines Agency)

victrelis

merck sharp dohme ltd - boceprevir - epatite Ċ, kronika - antivirali għal użu sistemiku - victrelis huwa indikat għall-kura ta ' l-infezzjoni tal-ġenotip-1 kronika epatite-c (chc), flimkien mal-peginterferon alfa u ribavirin, fil-pazjenti adulti b ' mard tal-fwied kompensat li huma mhux ittrattat minn qabel jew li jkunu fallew terapija qabel.

Xelevia Kesatuan Eropah - Malta - EMA (European Medicines Agency)

xelevia

merck sharp & dohme b.v. - sitagliptin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - għall-pazjenti adulti b'dijabete tat-tip 2 mellitus, xelevia huwa indikat biex itejbu l-kontroll gliċemiku:bħala monoterapija:f'pazjenti li mhumiex ikkontrollati biżżejjed bid-dieta u l-eżerċizzju waħidhom u li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intolleranza;bħala terapija dupliċi orali flimkien mal:metformin meta d-dieta u l-eżerċizzju flimkien ma 'metformin waħdu ma jipprovdux kontroll gliċemiku adegwat;sulphonylurea meta d-dieta u l-eżerċizzju flimkien ma' doża massima tollerata ta ' sulphonylurea waħedhom ma jipprovdux kontroll gliċemiku adegwat u meta metformin ma jkunx adegwat minħabba kontraindikazzjonijiet jew intolleranza;a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. thiazolidinedione) meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma 'l-agonist ppary waħdu ma jipprovdux kontroll gliċemiku adegwat;bħala terapija trippla orali f'kombinazzjoni ma': sulphonylurea u metformin meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat;ppary agonista u metformin meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku adegwat. xelevia huwa wkoll indikat bħala żieda mal-insulina (bil-metformina jew mingħajrha) meta d-dieta u l-eżerċizzju flimkien ma doża stabbli ta ' l-insulina ma jipprovdux kontroll gliċemiku adegwat.

Vylaer Spiromax Kesatuan Eropah - Malta - EMA (European Medicines Agency)

vylaer spiromax

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - vylaer spiromax huwa indikat fl-adulti ta '18-il sena' l fuq biss. asthmavylaer spiromax huwa indikat fit-trattament regolari ta ' l-ażżma, fejn l-użu tal-kombinazzjoni (kortikosterojdi meħuda man-nifs u li jaħdem fit-tul β2 adrenoceptor agonist) huwa xieraq:f'pazjenti li mhumiex adegwatament ikkontrollati bil-kortikosterojdi meħuda man-nifs u l - "kif meħtieġ" man-nifs qasir waqt li jaġixxi β2 adrenoceptor agonisti. fjorin pazjenti li diġà ikkontrollati adegwatament fuq iż-żewġ kortikosterojdi meħuda man-nifs u li jaħdem fit-tul β2 adrenoceptor agonisti. copdsymptomatic-trattament ta ' pazjenti b'indeboliment serju copd (fev1 < 50% mbassra-normal) u l-istorja tal-aggravar tal-attakki ripetuti, li għandhom sinifikanti sintomi minkejja regolari it-terapija b'taġixxi fit-tul bronkodilataturi.

Tesavel Kesatuan Eropah - Malta - EMA (European Medicines Agency)

tesavel

merck sharp & dohme b.v. - sitagliptin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - għall-pazjenti b'dijabete tat-tip 2 mellitus, tesavel huwa indikat biex itejbu l-kontroll gliċemiku:bħala monoterapija:f'pazjenti li mhumiex ikkontrollati biżżejjed bid-dieta u l-eżerċizzju waħidhom u li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intolleranza;bħala terapija dupliċi orali flimkien mal:metformin meta d-dieta u l-eżerċizzju flimkien ma 'metformin waħdu ma jipprovdux kontroll gliċemiku adegwat;sulphonylurea meta d-dieta u l-eżerċizzju flimkien ma' doża massima tollerata ta ' sulphonylurea waħedhom ma jipprovdux kontroll gliċemiku adegwat u meta metformin ma jkunx adegwat minħabba kontraindikazzjonijiet jew intolleranza;a ppary agonist (i. thiazolidinedione) meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma ' l-agonist ppary waħdu ma jipprovdux kontroll gliċemiku adegwat;bħala terapija trippla orali f'kombinazzjoni bi sulphonylurea u metformin meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn l-aġenti ma jipprovdux kontroll gliċemiku adegwat;peroxisome-proliferator-activated-riċettur gamma (ppary) agonist u metformin meta l-użu ta'l-agonist ppary huwa xieraq u meta d-dieta u l-eżerċizzju flimkien ma doppju it-terapija b'dawn l-aġenti ma jipprovdux kontroll gliċemiku adegwat. tesavel huwa indikat ukoll bħala add-on għall-insulina (bil-metformina jew mingħajrha) meta d-dieta u l-eżerċizzju flimkien ma stabbli fid-dożaġġ ta ' l-insulina ma jipprovdux kontroll gliċemiku adegwat.

Sitagliptin SUN Kesatuan Eropah - Malta - EMA (European Medicines Agency)

sitagliptin sun

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Sitagliptin Accord Kesatuan Eropah - Malta - EMA (European Medicines Agency)

sitagliptin accord

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Degarelix Accord Kesatuan Eropah - Malta - EMA (European Medicines Agency)

degarelix accord

accord healthcare s.l.u. - degarelix acetate - neoplasmi prostatiċi - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.