Europäische Union - Maltesisch - EMA (European Medicines Agency)

accord healthcare s.l.u. - posaconazole - mikosijiet - antimikotiċi għal użu sistemiku - posaconazole ahcl suspensjoni orali huwa indikat għall-użu fil-kura ta ' l-infezzjonijiet tal-fungu fl-adulti:asperġillożi invażiva f'pazjenti b'mard li hu refrattarju għal amphotericin b jew itraconazole jew f'pazjenti intolleranti għal dawn il-prodotti mediċinali;fusarjożi f'pazjenti b'mard li hu refrattarju għal amphotericin b jew f'pazjenti intolleranti għal amphotericin b;kromoblastomikożi u miċetoma f'pazjenti b'mard li hu refrattarju għal itraconazole jew f'pazjenti intolleranti għal itraconazole;kokkidajojdomikożi f'pazjenti b'mard li hu refrattarju għal amphotericin b, itraconazole jew fluconazole jew f'pazjenti intolleranti għal dawn il-prodotti mediċinali. kandidijażi orofarinġali: bħala l-kura preferita f'pazjenti li għandhom mard sever jew li huma immunokompromessi, li r-rispons għal terapija topika hija mistennija li tkun fqir. ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew nuqqas ta 'titjib wara minimu ta' 7 ijiem ta 'dożi terapewtiċi preċedenti ta' terapija antifungali effettiva. posaconazole ahcl suspensjoni orali huwa indikat ukoll għal profilassi ta 'infezzjonijiet fungali invażivi fil-pazjenti li ġejjin:pazjenti li kienu qed jirċievu remissjoni-induzzjoni ta' kimoterapija għal lewkimja majeloġenuża akuta (aml) jew għal sindromi majelodisplastiċi (mds) mistennija li jikkawżaw newtropenja u li huma f'riskju għoli li jiżviluppaw infezzjonijiet tal-fungu invażivi;trapjant ta'ċelloli staminali ematopojetiċi (hsct) riċevituri li huma għaddejjin minn doża għolja ta ' terapija immunosopprimenti għal-graft kontra l-host u li huma f'riskju għoli li jiżviluppaw infezzjonijiet invażivi tal-fungu.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

instituto grifols s.a. - fostamatinib disodium - tromboċitopenja - sistemiċi oħra hemostatics - tavlesse huwa indikat għall-kura ta immuni kronika tromboċitopenja (itp) f'pazjenti adulti li huma refrattarji għall-kuri oħra.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

viiv healthcare b.v. - fostemsavir trometamol - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

biocodex - stiripentol - epilessija mijoklonika, minorenni - anti-epilettiċi, - diacomit huwa indikat għall-użu flimkien ma ' clobazam u valproate bħala terapija adjunctive tal-refrattorji Ġeneralizzata tonic-clonic b'sekwestru fil-pazjenti bl-epilessija myoclonic severa fil infancy (smei, tal dravet syndrome) b'sekwestru tagħhom ma jkunux adekwatament ikkontrollat ma clobazam u valproate.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cobicistat, atazanavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - evotaz is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1 infected adults and adolescents (aged 12 years and older weighing at least 35 kg) without known mutations associated with resistance to atazanavir (see sections 4. 4 u 5.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

hra pharma rare diseases - ketoconazole - is-sindromu ta 'cushing - antimikotiċi għal użu sistemiku - ketoconazole hra huwa indikat għat-trattament tas-sindrome endoġenu ta 'cushing f'adulti u adolexxenti' l fuq minn 12-il sena.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

astrazeneca ab - olaparib - neoplażmi fl-ovarji - aġenti antineoplastiċi - ta 'l-ovarji cancerlynparza huwa indikat bħala monoterapija għall -: l-manteniment tat-trattament ta' pazjenti adulti b'avvanzat (medjevali stadji iii u iv) brca1/2 mutat (linja ġerminali u/jew somatiċi) ta 'grad għoli ta' l-epitilju ta 'l-ovarji, tubu fallopjan jew primarja peritoneali-kanċer li huma fir-rispons (sħiħa jew parzjali) wara t-tlestija ta' l-ewwel linja bbażata fuq il-platinu ' kimoterapija. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 u 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. il-pazjenti għandu jkollhom qabel kienu kkurati bil-anthracycline u taxane fil - (neo)adjuvant jew metastatiku-istabbiliment sakemm il-pazjenti li ma kienux tajbin għal dawn it-trattamenti (ara sezzjoni 5. pazjenti bl-ormon tat-riċettur (hr)-kanċer tas-sider posittiv għandu wkoll għamlu progress fuq jew wara qabel l-terapija endokrinali, jew jiġu kkunsidrati bħala mhux adattati għal terapija endokrinali. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, kobikistat, emtricitabine, tenofovir disoproxil fumarate - infezzjonijiet ta 'hiv - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - trattament tal-virus ta ' immunodefiċjenza umani 1 (hiv 1) infezzjoni fl-adulti età 18 snin jew aktar li huma naïve tat-trattament tal-antiretroviral jew li huma infettati bl-hiv 1 mingħajr mutazzjonijiet magħrufa assoċjati ma ' reżistenza għal kwalunkwe tat-tliet aġenti antiretroviral fl stribild.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

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.

Europäische Union - Maltesisch - EMA (European Medicines Agency)

gilead sciences ireland uc - cobicistat - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.