Gardasil 9 Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gardasil 9

merck sharp & dohme b.v. - vaċċin tal-papillomavirus uman [tipi 6, 11, 16, 18, 31, 33, 45, 52, 58] (rikombinanti, assorbjati) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - vaċċini għal papillomavirus - gardasil 9 huwa indikat għall-immunizzazzjoni attiva ta 'l-individwi mill-età ta'9 snin kontra l-hpv-mard:premalignant leżjonijiet u l-kanċer li jaffettwa l-ċerviċi, vulva, tal-vaġina u l-anus ikkawżat minn hpv ta' vaċċin typesgenital-felul (kondiloma acuminata) ikkawżata mill-speċifiċi tipi ta ' hpv. ara t-taqsimiet 4. 4 u 5. 1 għal tagħrif importanti dwar l-informazzjoni li ssostni dawn l-indikazzjonijiet. l-użu ta ' gardasil 9 għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Stivarga Unjoni Ewropea - Malti - EMA (European Medicines Agency)

stivarga

bayer pharma ag - regorafenib - neoplażmi kolorettali - antineoplastic agents, protein kinase inhibitors - stivarga huwa indikat bħala monoterapija għall-kura ta ' pazjenti adulti bil:kanċer metastatiku tal-kolorektum (crc) li kienu kkurati minn qabel b', jew mhumiex ikkunsidrati li huma kandidati għall, disponibbli terapiji - dawn jinkludu kimoterapija bbażata fuq fluoropyrimidine, kontra l-vegf-terapija u anti-egfr-terapija;li ma jistgħax jitneħħa kirurġikament, jew li mmetastatizza tumuri stromali gastro-intestinali (gist) li mexa fuq jew li huma intolleranti għal qabel għal trattament b'imatinib u sunitinib;karċinoma epatoċellulari (hcc) li kienu kkurati minn qabel b'sorafenib.

Regranex Unjoni Ewropea - Malti - EMA (European Medicines Agency)

regranex

janssen-cilag international nv - becaplermin - wound healing; skin ulcer - preparazzjonijiet għat-trattament ta 'feriti u ulċeri - regranex huwa indikat, b ' assoċjazzjoni ma ' oħra miżuri ta ' kura tajba ferita, biex jippromwovu granulazzjoni u b'hekk il-fejqan ta ' sħiħa tal-ħxuna, neuropathic, kroniċi, diabetic ulċeri inqas minn jew ugwali għal 5 cm2.

Topotecan Actavis Unjoni Ewropea - Malti - EMA (European Medicines Agency)

topotecan actavis

actavis group ptc ehf - topotecan - uterine cervical neoplasms; small cell lung carcinoma - aġenti antineoplastiċi - monoterapija b'topotecan hija indikata għat-trattament ta 'pazjenti b'kanċer tal-pulmun taċ-ċelluli żgħar li reġa' feġġa (sclc) li għalih it-trattament mill-ġdid bir-reġimen ta 'l-ewwel linja mhuwiex ikkunsidrat xieraq. topotecan flimkien ma ' cisplatin huwa indikat għall-pazjenti b'karċinoma taċ-ċerviċi rikorrenti wara radjuterapija u għall-pazjenti bil-marda fl-istadju ivb. pazjenti li qabel kellhom esponiment għal-cisplatin jinħtieġu intervall sostnut mingħajr trattament biex jiġġustifika trattament bil-kombinazzjoni.

Tygacil Unjoni Ewropea - Malti - EMA (European Medicines Agency)

tygacil

pfizer europe ma eeig - tigecycline - bacterial infections; skin diseases, bacterial; soft tissue infections - antibatteriċi għal użu sistemiku, - tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: , complicated skin and soft tissue infections (cssti), excluding diabetic foot infections, complicated intra-abdominal infections (ciai) , tygacil should be used only in situations where other alternative antibiotics are not suitable. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi. l-użu xieraq ta ' sustanzi antibatteriċi.

Hyrimoz Unjoni Ewropea - Malti - EMA (European Medicines Agency)

hyrimoz

sandoz gmbh - adalimumab - arthritis, rheumatoid; arthritis, psoriatic; spondylitis, ankylosing; uveitis; hidradenitis suppurativa; colitis, ulcerative; arthritis, juvenile rheumatoid; crohn disease; skin diseases, papulosquamous - immunosoppressanti - rheumatoid arthritishyrimoz in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hyrimoz jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. juvenile idiopathic arthritis- polyarticular juvenile idiopathic arthritishyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). hyrimoz jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta trattamenti fit-tul b'methotrexate mhux adattat. adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. - enthesitis-related arthritishyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritis- ankylosing spondylitis (as)hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. - axial spondyloarthritis without radiographic evidence of ashyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and / or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. psoriatic arthritishyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. adalimumab ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi periferali kif imkejjel permezz ta' x-ray f'pazjenti b'sottotipi poliartikulari simmetriċi tal-marda, u li jtejjeb il-funzjoni fiżika. psoriasishyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy. crohn’s diseasehyrimoz is indicated for treatment of moderately to severely active crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehyrimoz is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and / or an immunomodulator, or who are intolerant to or have contraindications for such therapies.  paediatric ulcerative colitishyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. ulcerative colitishyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitishyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Cimzia Unjoni Ewropea - Malti - EMA (European Medicines Agency)

cimzia

ucb pharma sa  - certolizumab pegol - artrite, rewmatika - immunosoppressanti - rewmatika arthritiscimzia, flimkien ma ' methotrexate (mtx), huwa indikat għall -: - trattament ta moderata sa severa, artrite rewmatojde attiva (ra) f'pazjenti adulti meta r-rispons għall li jimmodifikaw il-marda mediċini anti-rewmatiċi (dmards), inkluż mtx, kienet inadegwata. cimzia jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux inappropriatethe trattament ta severa, attiva u progressiva f'adulti li ma kinux ittrattati qabel ma ' mtx jew dmards oħra. cimzia kien muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' mtx. assjali aksjali cimzia huwa indikat għall-kura ta ' pazjenti adulti b'attiva severa assjali aksjali, li jinkludu:l-ankylosing spondylitis (as)adulti b'ankylosing spondylitis severa u attiva li kellhom rispons mhux adegwat għal, jew li huma intolleranti għal mediċini anti-infjammatorji mhux sterojdi (nsaids). assjali aksjali mingħajr evidenza

Votrient Unjoni Ewropea - Malti - EMA (European Medicines Agency)

votrient

novartis europharm limited  - pazopanib - karċinoma, Ċellula renali - aġenti antineoplastiċi - tal-kliewi-karċinoma taċ-ċellola (rcc)votrient huwa indikat fl-adulti għall-ewwel linja ta ' trattament ta avvanzat tal-kliewi-karċinoma taċ-ċellola (rcc) u għall-pazjenti li rċevew terapija minn qabel b'ċitokini għal marda avvanzata. sarkoma tat-tessuti rotob (sts)votrient huwa indikat għall-kura ta 'pazjenti adulti b'selettiv sottotipi ta' sarkoma tat-tessuti rotob (sts) u li jkunu ħadu l-kimoterapija qabel, għal mard metastatiku jew li għamlu progress fi żmien 12-il xahar ta'wara (neo)terapija miżjuda. l-effikaċja u s-sigurtà għandhom biss ġewx stabbiliti f'ċerti sts istoloġika tat-tumur sottotipi.

Ulipristal Acetate Gedeon Richter Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ulipristal acetate gedeon richter

gedeon richter plc. - ulipristal acetate - leiomyoma - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - ulipristal acetate huwa indikat għall-kors wieħed ta 'kura ta' qabel l-operazzjoni tat-trattament minn moderat sa sever is-sintomi tal-fibrojdi fl-utru f'nisa adulti ta ' età riproduttiva. ulipristal acetate huwa indikat għat-trattament intermittenti moderat għal sever is-sintomi tal-fibrojdi fl-utru f'nisa adulti ta ' età riproduttiva li mhumiex eliġibbli għall-kirurġija.

Abraxane Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abraxane

bristol-myers squibb pharma eeig - paclitaxel - breast neoplasms; pancreatic neoplasms; carcinoma, non-small-cell lung - aġenti antineoplastiċi - bħala mediċina weħidha, abraxane hu indikat għall-kura ta ' kanċer metastatiku tas-sider f'pazjenti adulti li jkunu fallew l-kura tal-ewwel linja għall-mard metastatiku u li għalihom standard, terapija li jkun fiha anthracycline ma tkunx indikata. abraxane flimkien ma 'gemcitabine huwa indikat għall-kura tal-ewwel linja ta' pazjenti adulti b'kanċer metastatiku tal-adenokarċinoma tal-frixa. abraxane f'kombinazzjoni ma 'carboplatin huwa indikat għall-kura tal-ewwel linja ta taċ-ċelluli mhux żgħar tal-pulmun il-kanċer fil-pazjenti adulti li mhumiex kandidati għall-potenzjalment kurattiva-kirurġija u/jew terapija ta' radjazzjoni.