Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belimumab - lupus eritematoso, sistemiku - immunosoppressanti - benlysta huwa indikat bħala terapija add-on f'pazjenti b'età ta ' 5 snin u akbar bi attiva, awtoantikorpi pożittivi lupus eritematosus sistemika (sle) bil-livell għoli ta'attività tal-marda (e. , pożittivi kontra dsdna u baxxa jikkumplimentaw) minkejja terapija standard. benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - asthma biresp spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β₂ adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β₂ adrenoceptor agonists. orin patients already adequately controlled on both inhaled corticosteroids and long-acting β₂ adrenoceptor agonists. copdbiresp spiromax is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev₁).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration ltd. - ibandronic acid - l-osteoporożi, il-menopawża - drogi għat-trattament ta 'mard tal-għadam - trattament ta 'l-osteoporożi f'nisa wara l-menopawża b'riskju akbar ta' ksur. tnaqqis fir-riskju ta ' ksur vertebrali ġie muri. l-effikaċja fuq tal-femora-għonq ksur għadha ma ġietx stabbilita.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig - bosutinib (bħala monoidrat) - lewkimja, myeloid - antineoplastic agents, protein kinase inhibitors - bosulif huwa indikat għat-trattament ta ' pazjenti adulti:għadhom kif ġew dijanjostikati fażi l-kronika (pk) philadelphia chromosome pożittivi għall-lewkimja tal-mudullun kronika (ph+ cml). cp, fil-fażi aċċelerata (ap), u blast phase (bp) ph+ cml li kienu kkurati qabel b'wieħed jew aktar ta 'tyrosine kinase(i) [tki(i)] u li għalihom imatinib, nilotinib u l-dasatinib ma huma kkunsidrati għażliet ta' trattament adattati.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

covis pharma europe b.v. - aclidinium bromide - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - bretaris genuair huwa indikat bħala trattament ta 'manteniment tal-bronkodilatur biex itaffi s-sintomi f'pazjenti adulti b'mard pulmonari ostruttiv kroniku (copd).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - ticagrelor - peripheral vascular diseases; acute coronary syndrome - aġenti antitrombotiċi - brilique, ko-amministrat ma 'acetylsalicylic acid (asa), huwa indikat għall-prevenzjoni ta'avvenimenti aterotrombotiċi f'pazjenti adulti withacute sindromi koronarji (acs) l-ora l-istorja tal-infart mijokardijaku (mi) u l-għoli tar-riskju ta'l-iżvilupp ta'aterotrombotiċi eventbrilique, mogħti flimkien ma'acetyl salicylic acid (asa), huwa indikat għall-prevenzjoni ta'avvenimenti aterotrombotiċi f'pazjenti adulti bi storja ta' infart mijokardijaku (mi seħħew mill-inqas sena ilu) u l-għoli tar-riskju ta'l-iżvilupp ta'aterotrombotiċi-avveniment.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

h. lundbeck a/s - vortioxetine - disturb depressiv, maġġur - psychoanaleptics, - trattament ta 'episodji depressivi maġġuri fl-adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pharmaxis europe limited - mannitol - fibrożi ċistika - sogħla u preparazzjonijiet kesħin - bronchitol huwa indikat għat-trattament tal-fibrożi ċistika (fk) f'adulti ta '18-il sena' l fuq bħala terapija add-on għall-aħjar standard ta 'kura.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - budesonide / formoterol teva huwa indikat fl-adulti ta '18-il sena' l fuq biss. asthmabudesonide/formoterol teva 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.