Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - bevacizumab - carcinoma, non-small-cell lung; breast neoplasms; ovarian neoplasms; colorectal neoplasms; carcinoma, renal cell - aġenti antineoplastiċi - bevacizumab flimkien ma 'kimoterapija bbażata fuq fluoropyrimidine huwa indikat għall-kura ta' pazjenti adulti b'karċinoma metastatika tal-kolon jew tar-rektum. bevacizumab f'kombinazzjoni ma 'paclitaxel, huwa indikat għall-kura preferita ta' pazjenti adulti b'kanċer metastatiku tas-sider. għal aktar informazzjoni kif tal-bniedem tar-riċettur tal-fattur tat-tkabbir epidermali 2 (her2) status. bevacizumab f'kombinazzjoni ma 'capecitabine huwa indikat għall-kura preferita ta' pazjenti adulti b'kanċer metastatiku tas-sider li fihom it-trattament bil-kimoterapija oħra għażliet inklużi l-tassani jew antraċiklini ma jkunx ikkunsidrat xieraq. pazjenti li rċivew korsijiet li fihom taxxaane u anthracycline fl-istabbiliment awżiljarju fl-aħħar 12-il xahar għandhom jiġu esklużi mit-trattament b'avastin flimkien ma 'capecitabine. għal aktar informazzjoni dwar her2-istatus. bevacizumab, barra minn hekk 'kimoterapija bbażata fuq platinum, huwa ndikat għall-kura preferita ta' pazjenti adulti li ma jistax jitneħħa, avvanzat, li mmetastatizza jew rikorrenti taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija ta ' ċelluli skwamużi. bevacizumab, f'kombinazzjoni ma 'erlotinib, huwa indikat għall-kura preferita ta' pazjenti adulti li ma jistax jitneħħa, avvanzat, li mmetastatizza jew rikorrenti mhux squamous taċ-ċelluli mhux żgħar tal-pulmun il-kanċer mar-riċettur tal-fattur tat-tkabbir epidermali (egfr) mutazzjonijiet li jattivaw. bevacizumab f'kombinazzjoni ma 'interferon alfa-2a huwa indikat għall-ewwel linja tal-kura ta' pazjenti adulti b'avvanzat u/jew metastatiku taċ-ċelluli renali kanċer. bevacizumab, f'kombinazzjoni ma 'carboplatin u paclitaxel huwa ndikat għall-quddiem il-linja ta 'trattament ta' pazjenti adulti b'avvanzati (il-federazzjoni internazzjonali tal-mard tal-ġilda u l-ostetriċja (medjevali) stadji iii b, iii u iv) ta 'l-epitilju ta' l-ovarji, l-tubu fallopjan, jew primarja peritoneali-kanċer. bevacizumab, f'kombinazzjoni ma 'carboplatin u gemcitabine, huwa indikat għall-kura ta' pazjenti adulti bil-ewwel rikorrenza tal-sensittiva għall-platinum ta 'l-epitilju ta' l-ovarji, l-tubu fallopjan jew primarja peritoneali-kanċer li ma rċevew terapija minn qabel ma 'bevacizumab, jew l-oħra' impedituri vegf jew vegf–riċetturi fil-mira l-aġenti. bevacizumab f'kombinazzjoni ma 'paclitaxel, topotecan, jew pegylated liposomal doxorubicin huwa indikat għat-trattament ta' pazjenti adulti bil-platinu-reżistenti rikorrenti ta 'l-epitilju ta' l-ovarji, l-tubu fallopjan, jew primarja peritoneali-kanċer li ma rċeviet l-ebda aktar minn żewġ qabel ma 'korsijiet ta' kimoterapija u li qatt ma kienu rċevew terapija minn qabel ma 'bevacizumab, jew l-oħra' impedituri vegf jew vegf–riċetturi fil-mira l-aġenti. bevacizumab, flimkien ma 'paclitaxel u cisplatin jew, alternattivament, paclitaxel u topotecan f'pazjenti li ma jistgħux jirċievu l-platinum-terapija, huwa indikat għall-kura ta' pazjenti adulti b'persistenti, rikorrenti, jew karċinoma metastatika taċ-ċerviċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda manufacturing austria ag - proteina umana c - purpura fulminans; protein c deficiency - aġenti antitrombotiċi - ceprotin is indicated for prophylaxis and treatment of  purpura fulminans  coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein c deficiency.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

recordati netherlands b.v. - tienzanib - karċinoma, Ċellula renali - aġenti antineoplastiċi - fotivda huwa indikat għall-ewwel trattament linja ta ' l-adulti pazjenti b ' karċinoma taċ-ċelluli renali avvanzati (rcc) u għall-pazjenti adulti li huma vegfr u mtor il-mogħdija inhibitor-naïve wara progressjoni tal-marda wara t-trattament minn qabel waħda ma cytokine terapija għall rcc avvanzati. it-trattament ta ' karċinoma taċ-ċellola renali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - upadacitinib - artrite, rewmatika - immunosoppressanti - rheumatoid arthritisrinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (dmards). rinvoq may be used as monotherapy or in combination with methotrexate. psoriatic arthritisrinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more dmards. rinvoq may be used as monotherapy or in combination with methotrexate. axial spondyloarthritisnon-radiographic axial spondyloarthritis (nr-axspa)rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri), who have responded inadequately to nonsteroidal anti-inflammatory drugs (nsaids). ankylosing spondylitis (as, radiographic axial spondyloarthritis)rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. atopic dermatitisrinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. ulcerative colitisrinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.  crohn’s diseaserinvoq is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - afoxolaner, milbemiċin oxime - endectocides, prodotti kontra l-parassiti, insettiċidi u sustanzi, milbemiċin oxime, kombinazzjonijiet - klieb - għat-trattament tal-briegħed u l-qurdien jigdem fil-klieb meta l-prevenzjoni tal-mard tal-heartworm (dirofilaria immitis larva), angiostrongylosis (tnaqqis fil-livell tal-adulti immaturi (l5) u adulti ta ' angiostrogylus vasorum), thelaziosis (adulti thelazia callipaeda) u/jew trattament ta gastro-nematodu infestazzjonijiet huwa indikat. it-trattament minn infestazzjonijiet tal-briegħed (ctenocephalides felis u c. canis) fil-klieb għal 5 ġimgħat. it-trattament ta ' qurdien infestazzjonijiet (dermacentor reticulatus, ixodes ricinus, ixodes hexagonus, rhipicephalus sanguineus) fil-klieb, għal 4 ġimgħat. il-briegħed u l-qurdien għandhom jingħaqdu ma 'l-ospitant u jibdew jgħumu sabiex ikunu esposti għas-sustanza attiva. it-trattament ta ' infestazzjonijiet bil-adulti gastrointestinali, nematodi tal-ispeċijiet li ġejjin: - imsaren (toxocara canis u toxascaris leonina), anċilostomi (ancylostoma caninum, ancylostoma braziliense u ancylostoma ceylanicum) u ħniex (trichuris vulpis). trattament ta ' domodicosis (ikkawżata minn demodex canis). kura għal sarcoptic mange (ikkawżata minn sarcoptes scabiei var. canis). il-prevenzjoni tal-mard tal-heartworm (dirofilaria immitis larva) b'amministrazzjoni kull xahar. il-prevenzjoni ta angiostrongylosis (bit-tnaqqis tal-livell ta 'l-infezzjoni bil-adulti immaturi (l5) u l-adulti l-istadji ta' angiostrogylus vasorum) b'amministrazzjoni kull xahar. il-prevenzjoni ta'l-istabbiliment tal-thelaziosis (adulti thelazia callipaeda eyeworm l-infezzjoni) b'amministrazzjoni kull xahar.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

theravia - dexamethasone - majloma multipla - kortikosterojdi għal użu sistemiku - trattament ta 'majeloma multipla.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

theramex ireland limited - linzagolix choline - leiomyoma - ormoni u analogi pitwitarji u ipotalamiċi - yselty is indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ceva santé animale - vaċċin inattivat ta 'coxiella burnetii, strain nine mile - immunologicals for bovidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - goats; cattle - cattle: , for the active immunisation of cattle to lower the risk for non-infected animals vaccinated when non-pregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of coxiella burnetii in these animals via milk and vaginal mucus. , onset of immunity: not established. , duration of immunity: 280 days after completion of the primary vaccination course. , goats: , for the active immunisation of goats to reduce abortion caused by coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta. , onset of immunity: not established. , duration of immunity: one year after completion of the primary vaccination course.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - sklerosi multipla - immunosuppressanti selettivi - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).