Європейський Союз - мальтійська - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - sklerosi multipla - immunosuppressanti selettivi - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 u 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Європейський Союз - мальтійська - EMA (European Medicines Agency)

biogen netherlands b.v. - nusinersen sodium - atrofija muskolari, spinali - drogi oħra tas-sistema nervuża - spinraza hija indikata għat-trattament ta '5q atrofija muskolari spinali.

Європейський Союз - мальтійська - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Європейський Союз - мальтійська - 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.

Європейський Союз - мальтійська - EMA (European Medicines Agency)

viatris limited - ċitrat ta 'sildenafil - pressjoni għolja, pulmonari - uroloġiċi - adultstreatment ta ' pazjenti adulti bi pressjoni għolja arterjali tal-pulmun ikklassifikata bħala klassi funzjonali who ii u iii, biex itejbu l-kapaċità għall-eżerċizzju. l-effikaċja intweriet fl-ipertensjoni primarja pulmonari u pressjoni għolja pulmonari assoċjata ma 'mard tat-tessut konnettiv. pedjatriċi populationtreatment tal-pazjenti pedjatriċi li kellhom minn sena 1 sa 17-il sena bi pressjoni arterjali pulmonari għolja. l-effikaċja f'termini ta 'titjib tal-kapaċità ta' eżerċizzju jew ta 'emodinamiċità pulmonari intweriet fl-ipertensjoni primarja pulmonari u pressjoni għolja pulmonari assoċjata ma' mard tal-qalb konġenitali (ara sezzjoni 5.

Європейський Союз - мальтійська - EMA (European Medicines Agency)

mylan ireland limited - l-arsenic trioxide - lewkimja, promyelocytic, akuta - aġenti antineoplastiċi - l-arsenic trioxide mylan huwa indikat għall-induzzjoni tar-remissjoni u l-konsolidazzjoni f'pazjenti adulti bi:- li għadhom kif ġew dijanjostikati baxx intermedju-riskju tal-lewkimja promijeloċitika akuta (apl) (ċelluli bojod tad-demm, ≤ 10 x 103/µl) fil-kombinazzjoni ma'l trans retinoic acid (atra)- li reġgħet tfaċċat/refrattarja-lewkimja promijeloċitika akuta (apl) (t-trattament preċedenti kellha tinkludi xi retinojdi u l-kemoterapija)ikkaratterizzata mill-preżenza ta ' l-t(15;17) traslokazzjoni u/jew il-preżenza tal-lewkimja promijeloċitika/retinoic acid receptor-alpha (pml/rar-alfa) tal-ġene. ir-rata ta ' rispons ta oħra akuti lewkimja miloġenja-sottotipi għall-arsenic trioxide ma beenexamined.

Європейський Союз - мальтійська - 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.

Європейський Союз - мальтійська - EMA (European Medicines Agency)

mylan ireland limited - dimetil fumarate - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Європейський Союз - мальтійська - EMA (European Medicines Agency)

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - immunosoppressanti - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Європейський Союз - мальтійська - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drogi użati fid-dijabete - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 u 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.