यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - tumur stromali gastrointestinali - aġenti antineoplastiċi oħra, inibituri tal-proteina kinase - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - aġenti antineoplastiċi - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pazjenti li għandhom livell baxx jew l-riskju baxx ħafna ta ' rikorrenza m'għandhomx jirċievu kura awżiljarja. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. Ħlief fil għadhom kif ġew dijanjostikati cml ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

gilead sciences ireland unlimited company - lenacapavir sodium - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - sunlenca injection, in combination with other antiretroviral(s), 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 (see sections 4. 2 u 5. sunlenca tablet, in combination with other antiretroviral(s), 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, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4. 2 u 5.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - aġenti antineoplastiċi - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5. renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - aġenti antineoplastiċi - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

glaxo group ltd. - amprenavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - agenerase, flimkien ma 'mediċini antiretrovirali oħra, huwa indikat għall-kura ta' impeditur protease (pi) b'esperjenza ta 'adulti infettati bl-hiv-1 u tfal' l fuq minn 4 snin. il-kapsuli ta 'agenerase għandhom normalment jiġu amministrati b'doża baxxa ta' ritonavir bħala stimulant farmakokinetiku ta 'amprenavir (ara sezzjonijiet 4. 2 u 4. l-għażla ta 'amprenavir għandha tkun ibbażata fuq ittestjar ta' reżistenza virali individwali u l-istorja tal-kura tal-pazjenti (ara sezzjoni 5. il-benefiċċju ta 'agenerase ma' ritonavir ma ntwerewx f'pi nave-pazjenti (ara sezzjoni 5.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

roche registration ltd. - nelfinavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - viracept huwa indikat fit-trattament ta 'kombinazzjoni antiretrovirali ta' adulti, adolexxenti u tfal ta 'tlett snin u ikbar li huma infettati bil-virus tal-bniedem-immunodefiċjenza (hiv-1). fl-protease inhibitor (pi) pazjenti b'esperjenza, l-għażla ta ' nelfinavir għandha tkun ibbażata fuq testijiet tar-reżistenza virali u l-istorja tat-trattament.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):għat-trattament ta ' l-hiv-1 infezzjoni fil-kura antiretrovirali (art)-l-esperjenza f'pazjenti adulti, inklużi dawk li ġew ħafna ttrattati minn qabel. għat-trattament ta 'l-hiv-1 infezzjoni fil-pazjenti pedjatriċi mill-eta' ta 3 snin u mill-inqas 15-il kg piż tal-ġisem. id-deċiżjoni li jinbeda it-trattament b'darunavir amministrat flimkien ma 'doża baxxa ta' ritonavir, għandha tingħata konsiderazzjoni kbira lill-istorja tat-trattament tal-pazjent individwali u l-mudelli ta 'tibdiliet ġenetiċi assocjati ma' mediċini differenti. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 u 5. darunavir amministrat flimkien ma 'doża baxxa ta' ritonavir huwa indikat, flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' pazjenti bil-vajrus tal-immunodefiċjenza umana (hiv-1) .  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. id-deċiżjoni li jinbeda it-trattament b'darunavir f'dawn l-arti-pazjenti b'esperjenza, ġenotipika l-ittestjar għandu jiggwida l-użu ta ' darunavir (ara sezzjonijiet 4. 2, 4. 3, 4. 4 u 5.

यूरोपीय संघ - माल्टीज़ - 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.

यूरोपीय संघ - माल्टीज़ - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, kobikistat - infezzjonijiet ta 'hiv - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta, huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' infezzjoni tal-virus tal-immunodefiċjenza umana 1 (hiv 1) f'adulti ta '18-il sena jew akbar. Ġenotipika l-ittestjar għandu jiggwida l-użu tal-rezolsta.