Unjoni Ewropea - Malti - EMA (European Medicines Agency)

otsuka novel products gmbh - delamanid - tuberkulożi, b'resistema multidrug - antimikobatterjali - deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (mdr-tb) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4. 2, 4. 4 u 5. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab vedotin - limfoma, b-cell - aġenti antineoplastiċi - polivy flimkien ma bendamustine u rituximab huwa indikat għall-kura ta ' pazjenti adulti b'reġgħet tfaċċat/refrattarja b kbira mxerrda-cell lymphoma (dlbcl) li mhumiex kandidati għall-trapjant ta'ċelloli staminali ematopojetiċi. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline trading services limited - sotrovimab - covid-19 virus infection - sera immuni u immunoglobulini, - xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (covid-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe covid-19.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vbi vaccines b.v. - antigen tal-wiċċ ta 'l-epatite b - epatite b - vaċċini - prehevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis b virus in adults. it can be expected that hepatitis d will also be prevented by immunisation with prehevbri as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection. the use of prehevbri should be in accordance with official recommendations.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - erlotinib - carcinoma, non-small-cell lung; pancreatic neoplasms - aġenti antineoplastiċi - taċ-ċelluli mhux żgħar tal-pulmun (nsclc)tarceva huwa indikat ukoll għall-jaqilbu trattament ta'manteniment fil-pazjenti b'lokalment avvanzat jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer ma 'egfr mutazzjonijiet li jattivaw u stabbli tal-marda wara l-ewwel linja ta' kimoterapija. tarceva huwa indikat ukoll għat-trattament ta 'pazjenti b'lokalment avvanzat jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer wara l-falliment ta' mill-inqas waħda minn qabel kors ta ' kimoterapija. f'pazjenti b'tumuri mingħajr egfr mutazzjonijiet li jattivaw, tarceva huwa indikat meta għażliet oħra ta'trattament mhumiex ikkunsidrati adattati. meta jiġi preskritt tarceva, fatturi assoċjati ma ' sopravivenza itwal għandhom jiġu kkunsidrati. l-ebda vantaġġ għas-sopravivenza oħra jew effetti klinikament rilevanti tal-kura ġew murija f'pazjenti b'-riċettur tal-fattur tat-tkabbir epidermali (egfr)-ihc - tumuri negattivi. - frixa cancertarceva flimkien ma 'gemcitabine huwa indikat għall-kura ta' pazjenti b'kanċer metastatiku tal-frixa. meta jiġi preskritt tarceva, fatturi assoċjati ma ' sopravivenza itwal għandhom jiġu kkunsidrati.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig - bortezomib - majloma multipla - aġenti antineoplastiċi oħra - bortezomib hospira bħala monoterapija jew flimkien ma 'liposomal doxorubicin jew dexamethasone hu indikat għall-kura ta' pazjenti adulti b'progressiva majeloma multipla li rċevew mill-anqas terapija 1 minn qabel u li diġà għaddew jew li mhumiex tajbin għal trapjant b ' ċelluli staminali ematopojetiċi. bortezomib hospira f'kombinazzjoni ma 'melphalan u prednisone huwa indikat għall-kura ta' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal doża għolja ta 'kimoterapija bi trapjant b' ċelluli staminali ematopojetiċi. bortezomib hospira flimkien ma 'dexamethasone, jew ma' dexamethasone u thalidomide, huwa indikat għall-kura ta 'induzzjoni ta' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li huma eliġibbli għal doża għolja ta 'kimoterapija bi trapjant b' ċelluli staminali ematopojetiċi. bortezomib hospira flimkien ma 'rituximab, cyclophosphamide, doxorubicin u prednisone huwa indikat għall-kura ta' pazjenti adulti li ma kienux ikkurati qabel f'forma ta'tubu taċ-ċelluli tal-limfoma li mhumiex tajbin għal trapjant b ' ċelluli staminali ematopojetiċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gilead sciences international ltd - elvitegravir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - vitekta ko amministrati bl-inibitur protease qawwa ritonavir u ma ' l-aġenti l-oħra antiretroviral, huwa indikat għall-kura ta ' l-infezzjoni (hiv-1) umani-immunodefiċjenza-virus-1 fl-adulti li huma infettati bl-hiv-1 mingħajr mutazzjonijiet magħrufa assoċjati ma ' reżistenza għall-elvitegravir.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - bortezomib - majloma multipla - aġenti antineoplastiċi - bortezomib bħala monoterapija jew flimkien ma 'liposomal doxorubicin jew dexamethasone hu indikat għall-kura ta' pazjenti adulti b'progressiva majeloma multipla li rċevew mill-anqas terapija 1 minn qabel u li diġà għaddew jew li mhumiex tajbin għal trapjant b ' ċelluli staminali ematopojetiċi. bortezomib flimkien ma 'melphalan u prednisone huwa indikat għall-kura ta' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal doża għolja ta 'kimoterapija bi trapjant b' ċelluli staminali ematopojetiċi. bortezomib flimkien ma 'dexamethasone, jew ma' dexamethasone u thalidomide, huwa indikat għall-kura ta 'induzzjoni ta' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li huma eliġibbli għal doża għolja ta 'kimoterapija bi trapjant b' ċelluli staminali ematopojetiċi. bortezomib flimkien ma 'rituximab, cyclophosphamide, doxorubicin u prednisone huwa indikat għall-kura ta' pazjenti adulti li ma kienux ikkurati qabel f'forma ta'tubu taċ-ċelluli tal-limfoma li mhumiex tajbin għal trapjant b ' ċelluli staminali ematopojetiċi.