Unjoni Ewropea - Malti - EMA (European Medicines Agency)

centus biotherapeutics europe limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; 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 dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. 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. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. 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 in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. 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)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - aġenti antineoplastiċi - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc). imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - sklerosi multipla - immunosuppressanti selettivi - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 u 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosoppressanti - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 u 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - gefitinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - iressa huwa indikat għall-kura ta 'pazjenti adulti b'lokalment avvanzat jew dak metastatiku li mhux żgħar tal-pulmun taċ-ċelluli tal-kanċer b'mutazzjonijiet li jattivaw tal-epidermali-tkabbir tal-fattur-riċetturi ta' tyrosine kinase.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig - crizotinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - xalkori as monotherapy is indicated for:the first‑line treatment of adults with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with previously treated anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with ros1‑positive advanced non‑small cell lung cancer (nsclc)the treatment of paediatric patients (age ≥6 to.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - gefitinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - antineoplastic agents, protein kinase inhibitors - gefitinib mylan huwa indikat bħala monoterapija għall-kura ta 'pazjenti adulti b'lokalment avvanzat jew dak metastatiku li mhux ta' ċelluli żgħar kanċer tal-pulmun (nsclc) b'mutazzjonijiet li jattivaw ta ' egfr‑tk.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan s.a.s. - docetaxel - head and neck neoplasms; carcinoma, non-small-cell lung; adenocarcinoma; prostatic neoplasms; breast neoplasms - aġenti antineoplastiċi - kura tal-kanċer tas-sider, forom speċjali ta 'kanċer tal-pulmun (kanċer tal-pulmun mhux ta' ċelluli żgħar), kanċer tal-prostata, kanċer gastriku jew kanċer tar-ras u l-għonq.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen biologics b.v. - golimumab - arthritis, psoriatic; spondylitis, ankylosing; colitis, ulcerative; arthritis, rheumatoid - immunosoppressanti - artrite rewmatojde (ra)zoely, flimkien ma ' methotrexate (mtx), huwa indikat għall -: - trattament ta moderata sa severa, artrite rewmatika attiva fl-adulti meta r-rispons għall li timmodifika l-marda anti rewmatiċi tad-droga (dmard) terapija inkluż mtx kienet inadegwata. il-kura ta attiva u progressiva severa, artrite rewmatika fl-adulti li ma kienux ittrattati qabel b'mtx. zoely, flimkien ma 'mtx, ġie muri li jnaqqas ir-rata ta' progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta ' x-ray, u li jtejjeb il-funzjoni fiżika. għall-informazzjoni dwar l-artrite idjopatika ġuvenili poliartikulari l-indikazzjoni, jekk jogħġbok ara l-zoely 50 mg smpc. artrite tal-psorijasi (psa)zoely, waħdu jew flimkien ma ' mtx, huwa indikat għall-kura tas-sustanza attiva u progressiva artrite psorjatika f'pazjenti adulti meta r-rispons għall-preċedenti dmard it-terapija kienet inadegwata. zoely 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. assjali spondyloarthritisankylosing ankilosanti (as)zoely huwa indikat għall-kura ta ' ankylosing spondylitis attiva fl-adulti li ma kellhomx rispons xieraq għat-terapija konvenzjonali. mhux radjografiku assjali aksjali (nr assjali spa)zoely huwa indikat għall-kura ta 'adulti bi ħsara severa, attiva mhux radjografiku assjali aksjali bil-għan sinjali ta' infjammazzjoni kif indikat mill-elevati c proteina reattiva (crp) u/jew l-immaġni tar-reżonanza manjetika (mri) l-evidenza, li kellhom rispons mhux adegwat għal, jew li huma intolleranti għal mediċini anti-infjammatorji mhux sterojdi (nsaids). kolite ulċerattiva (uc)zoely 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. idjopatika ġuvenili arthritispolyarticular-artrite idjopatika ġuvenili (pjia)zoely flimkien ma 'methotrexate (mtx), huwa indikat għall-kura tal-artrite idjopatika poliartikolari minorenni fit-tfal 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma' mtx. artrite rewmatojde (ra)zoely, flimkien ma ' methotrexate (mtx), huwa indikat għall -: - trattament ta moderata sa severa, artrite rewmatika attiva fl-adulti meta r-rispons għall li timmodifika l-marda anti rewmatiċi tad-droga (dmard) terapija inkluż mtx kienet inadegwata. il-kura ta attiva u progressiva severa, artrite rewmatika fl-adulti li ma kienux ittrattati qabel b'mtx. zoely, flimkien ma 'mtx, ġie muri li jnaqqas ir-rata ta' progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta ' x-ray, u li jtejjeb il-funzjoni fiżika. idjopatika ġuvenili arthritispolyarticular-artrite idjopatika ġuvenili (pjia)zoely flimkien ma 'mtx huwa indikat għall-kura tal-artrite idjopatika poliartikolari minorenni fit-tfal 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma' mtx. artrite tal-psorijasi (psa)zoely, waħdu jew flimkien ma ' mtx, huwa indikat għall-kura tas-sustanza attiva u progressiva artrite psorjatika f'pazjenti adulti meta r-rispons għall-preċedenti dmard it-terapija kienet inadegwata. zoely 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. assjali spondyloarthritisankylosing ankilosanti (as)zoely huwa indikat għall-kura ta ' ankylosing spondylitis attiva fl-adulti li ma kellhomx rispons xieraq għat-terapija konvenzjonali. mhux radjografiku assjali aksjali (nr assjali spa)zoely huwa indikat għall-kura ta 'adulti bi ħsara severa, attiva mhux radjografiku assjali aksjali bil-għan sinjali ta' infjammazzjoni kif indikat mill-elevati c proteina reattiva (crp) u/jew l-immaġni tar-reżonanza manjetika (mri) l-evidenza, li kellhom rispons mhux adegwat għal, jew li huma intolleranti għal mediċini anti-infjammatorji mhux sterojdi (nsaids). kolite ulċerattiva (uc)zoely 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

seqirus s.r.l.  - antiġeni tal-wiċċ tal-virus ta 'l-influwenza, inattivati: a / vjet nam / 1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaċċini ta 'l-influwenza - profilassi tal-influwenza f'sitwazzjoni pandemika ddikjarata uffiċjalment. il-vaċċin kontra l-influwenza pandemika għandu jintuża skond il-gwida uffiċjali.