Unjoni Ewropea - Malti - EMA (European Medicines Agency)

grünenthal gmbh - lesinurad - iperurċemija - preparazzjonijiet antigout - zurampic, f ' għaqda mal-inibitur oxidase xanthine, huwa indikat fl-adulti għall-trattament adjunctive ta ' hyperuricaemia fil-pazjenti gout (bi jew mingħajr tophi) li ma kisbux mira tas-serum uric acid livelli b ' doża xierqa ta ' l-oxidase ta ' xanthine inibitur waħdu.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biocryst - peramivir - influwenza, bniedem - antivirali għal użu sistemiku - alpivab huwa indikat għall-kura ta mhux ikkomplikati-influwenza fl-adulti u tfal mill-età ta ' 2 snin.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; psoriasis; arthritis, psoriatic; spondylitis, ankylosing; uveitis; colitis, ulcerative; crohn disease - immunosoppressanti - rewmatika arthritiskromeya flimkien ma ' methotrexate, huwa indikat għall -: - trattament ta moderata sa severa, artrite rewmatika attiva f'pazjenti adulti, meta r-rispons li jimmodifikaw il-marda anti-rewmatiċi-mediċini inkluż methotrexate, ma jkunx adegwat. il-kura ta attiva u progressiva severa, artrite rewmatika fl-adulti li ma kienux ittrattati qabel b'methotrexate. kromeya 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. idjopatika ġuvenili arthritispolyarticular idjopatika ġuvenili arthritiskromeya flimkien ma 'methotrexate huwa indikat għall-kura tal-attivi-artrite idjopatika ġuvenili poliartikulari, f'pazjenti mill-età ta' 2 snin li kellhom rispons inadegwat għal wieħed jew aktar li jimmodifikaw il-marda anti-rewmatiċi-mediċini (dmards). idacio jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal methotrexate jew meta titkompla l-kura b'methotrexate ma tkunx tajba (għall-effikaċja fil-monoterapija ara sezzjoni 5. adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. enthesitis relatati mal-arthritiskromeya huwa indikat għall-kura tal-attivi-artrite assoċjata ma'entesite fil-pazjenti, l-età ta ' 6 snin u akbar, li kellhom rispons mhux adegwat għal, jew li huma intolleranti għal, terapija konvenzjonali (ara sezzjoni 5. assjali spondyloarthritisankylosing ankilosanti (as)kromeya huwa indikat għall-kura ta ' adulti li jbatu minn ankylosing spondylitis attiva li kellhom rispons mhux adekwat għat-terapija. assjali aksjali mingħajr evidenza radjografika ta askromeya huwa indikat għall-kura ta 'adulti li jbatu minn assjali aksjali mingħajr evidenza radjografika ta' kif iżda bil-għan sinjali ta 'infjammazzjoni minn crp għoli u/jew ta' l-mri, li kellhom rispons mhux adegwat għal, jew li huma intolleranti għal mediċini anti-infjammatorji. psorjatika arthritiskromeya huwa indikat għall-kura tas-sustanza attiva u progressiva artrite psorjatika fl-adulti meta r-rispons għall-preċedenti li jimmodifikaw il-marda anti-rewmatiċi terapija bil-mediċina kienet inadegwata. 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 (ara sezzjoni 5. 1) u li jtejjeb il-funzjoni fiżika. psoriasiskromeya huwa indikat għall-kura moderata għal severa ta ' psorjasi tal-plakka kronika f'pazjenti adulti li huma kandidati għat-terapija sistemika. pedjatrika tal-plakka psoriasiskromeya huwa indikat għall-kura ta kroniku sever tal-psorjasi tal-plakka fit-tfal u fl-adolexxenti mill-età ta ' 4 snin li kellhom rispons inadegwat għal, jew huma xierqa għall-kandidati għal terapija topika u fototerapiji. crohn diseasekromeya huwa indikat għall-kura ta attiva minn moderata sa gravi marda ta ' crohn, f'pazjenti adulti li ma kellhomx rispons minkejja sħiħ u adegwat matul it-terapija b'xi corticosteroid u/jew immunosoppressanti; jew li huma intolleranti għal, jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn. pedjatriċi crohn diseasekromeya huwa indikat għall-kura ta attiva minn moderata sa gravi marda ta 'crohn f'pazjenti pedjatriċi (mill-età ta' 6 snin) li kellhom rispons mhux adekwat għat-terapija konvenzjonali, inkluż primarja nutrizzjoni-terapija u xi corticosteroid u/jew immunomodulatur, jew li ma jifilħux jew għandhom kontra-indikazzjonijiet għal dawn it-terapiji. kolite colitiskromeya huwa indikat għall-kura ta attiva minn moderata sa gravi kolite bl-ulċeri fil-pazjenti adulti li kellhom rispons mhux adekwat għat-terapija konvenzjonali, inkluż kortikosterojdi u 6 mercaptopurine (6-mp) jew azathioprine (aza), jew li huma intolleranti għal, jew li jkollhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn. uveitiskromeya huwa indikat għall-kura ta mhux infettiv intermedji, posterjuri u panuveitis f'pazjenti adulti li kellhom rispons mhux adegwat għall-kortikosterojdi, il-pazjenti fil-bżonn ta ' kortikosterojdi li ma jitilfux potassium, jew min-kura bil-kortikosterojdi huwa xieraq. pedjatriċi uveitiskromeya huwa indikat għall-kura ta kronika pedjatrika mhux infettiv uveite anterjuri f'pazjenti li għandhom minn 2-il sena li kellhom rispons mhux adegwat għal, jew li huma intolleranti għal terapiji konvenzjonali, jew li terapija konvenzjonali ma tkunx xierqa.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid; colitis, ulcerative; crohn disease; hidradenitis suppurativa; psoriasis; spondylitis, ankylosing; uveitis - immunosoppressanti - rheumatoid arthritishukyndra 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 (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. 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 arthritispolyarticular juvenile idiopathic arthritishukyndra 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 dmard. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. enthesitis-related arthritishukyndra 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 (see section 5. axial spondyloarthritisankylosing spondylitis (as)hukyndra is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of ashukyndra 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 (nsaids). psoriatic arthritishukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard 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 (ara sezzjoni 5. 1) u li jtejjeb il-funzjoni fiżika. psoriasishukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishukyndra 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)hukyndra is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 u 5. crohn’s diseasehukyndra 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 diseasehukyndra 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. ulcerative colitishukyndra 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. paediatric ulcerative colitishukyndra 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. uveitishukyndra 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 uveitishukyndra 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; spondylitis, ankylosing; arthritis, psoriatic; psoriasis; hidradenitis suppurativa; crohn disease; colitis, ulcerative; uveitis - immunosoppressanti - rheumatoid arthritislibmyris 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 (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. 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 arthritispolyarticular juvenile idiopathic arthritislibmyris 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 dmard. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab ma ġiex studjat f'pazjenti li għandhom inqas minn 2 snin. enthesitis-related arthritislibmyris 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 spondyloarthritisankylosing spondylitis (as)libmyris is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of aslibmyris 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 (nsaids). psoriatic arthritislibmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard 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. psoriasislibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasislibmyris 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)libmyris is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 u 5. crohn’s diseaselibmyris 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 diseaselibmyris 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. ulcerative colitislibmyris 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. paediatric ulcerative colitislibmyris 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. uveitislibmyris 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 uveitislibmyris 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vaċċini - ambirix huwa għall-użu f'persuni mhux immuni minn sena sa u li jinkludu 15-il sena għall-protezzjoni kontra l-infezzjoni tal-epatite-a u l-epatite-b. il-protezzjoni kontra l-epatite b infezzjonijiet tista'ma tinkisibx sa wara t-tieni doża. għalhekk:ambirix għandu jintuża biss meta jkun hemm riskju relattivament żgħir ta 'l-epatite b infezzjoni matul il-kors ta' tilqim;huwa rakkomandat li ambirix jingħata f'sitwazzjonijiet meta t-tlestija ta 'l-żewġ dożi tal-kors tal-vaċċinazzjoni tista' tkun assigurata.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - travoprost, timolol - glaucoma, open-angle; ocular hypertension - oftalmoloġiċi - it-tnaqqis tal-pressjoni intraocular (iop) fil-pazjenti adulti ma miftuħ-angolu glaucoma jew ipertensjoni okulari li huma responsivi biżżejjed biex beta-blockers topika jew analogi prostaglandin.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda pharma a/s - azilsartan medoxomil - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - edarbi huwa indikat għat-trattament tal-ipertensjoni essenzjali fl-adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - fulvestrant - neoplażmi tas-sider - endokrinali it-terapija, anti-estroġeni - faslodex is indicated , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. , , , in combination with palbociclib for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. , fil - pre- jew perimenopausal-nisa, il-kombinazzjoni tat-trattament bil-palbociclib għandu jkun ikkombinat ma ' ormon luteinizing releasing hormone (lhrh) agonist.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda pharma a/s - azilsartan medoxomil - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - ipreziv huwa indikat għat-trattament tal-ipertensjoni essenzjali fl-adulti.