Liên Minh Châu Âu - Tiếng Malt - EMA (European Medicines Agency)

eisai gmbh - lenvatinib mesilate - karċinoma, Ċellula renali - aġenti antineoplastiċi - kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (rcc):in combination with pembrolizumab, as first-line treatment (see section 5. in combination with everolimus, following one prior vascular endothelial growth factor (vegf)-targeted therapy.

Liên Minh Châu Âu - Tiếng Malt - EMA (European Medicines Agency)

eisai gmbh - lenvatinib mesilate - neoplażmi tat-tirojde - aġenti antineoplastiċi - lenvima huwa indikat bħala monoterapija għall-kura ta ' pazjenti adulti b'progressiva, lokalment avvanzat jew dak metastatiku, differenzjati (papillari/follikulari/hürthle taċ-ċelluli) karċinoma tat-tirojde (d), refrattarji għat-jodju radjuattiv (rai). lenvima huwa indikat bħala monoterapija għall-kura ta 'pazjenti adulti b'avvanzat jew wara falliment ta' karċinoma epatoċellulari (hcc) u li jkunu rċevew l-ebda terapija sistemika.

Liên Minh Châu Âu - Tiếng Malt - EMA (European Medicines Agency)

bayer ag  - vardenafil - disfunzjoni erettili - uroloġiċi - trattament ta 'disfunzjoni erettili f'irġiel adulti. id-disfunzjoni erettili hija l-inkapaċità li tinkiseb jew tinżamm erezzjoni tal-pene suffiċjenti għal prestazzjoni sesswali sodisfaċenti. biex levitra ikun effettiv, hija meħtieġa stimulazzjoni sesswali. levitra mhux indikat għall-użu min-nisa.

Liên Minh Châu Âu - Tiếng Malt - EMA (European Medicines Agency)

bayer ag  - vardenafil - disfunzjoni erettili - uroloġiċi - trattament ta 'disfunzjoni erettili f'irġiel adulti. id-disfunzjoni erettili hija l-inkapaċità li tinkiseb jew tinżamm erezzjoni tal-pene suffiċjenti għal prestazzjoni sesswali sodisfaċenti. biex vivanza ikun effettiv, hija meħtieġa stimulazzjoni sesswali. vivanza mhux indikat għall-użu min-nisa.

Liên Minh Châu Âu - Tiếng Malt - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - stavudine - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - iebes capsuleszerit huwa indikat flimkien ma ' prodotti mediċinali antiretrovirali oħra għat-trattament ta infettati bl-hiv pazjenti adulti u pazjenti pedjatriċi ('l fuq minn l-età ta'tliet xhur) biss meta l-mediċini antiretrovirali oħra ma jistgħux jintużaw. it-tul tat-terapija b'zerit għandha tiġi limitata għall-iqsar żmien possibbli. trab għall-ħalq solutionzerit huwa indikat flimkien ma ' prodotti mediċinali antiretrovirali oħra għat-trattament ta infettati bl-hiv pazjenti adulti u pazjenti pedjatriċi (mit-twelid) biss meta l-mediċini antiretrovirali oħra ma jistgħux jintużaw. it-tul tat-terapija b'zerit għandha tiġi limitata għall-iqsar żmien possibbli.

Liên Minh Châu Âu - Tiếng Malt - EMA (European Medicines Agency)

ab science - masitinib mesilate - mastocitosi - aġenti antineoplastiċi - it-trattament tal-mastocytosis.

Liên Minh Châu Âu - Tiếng Malt - EMA (European Medicines Agency)

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - aġenti antineoplastiċi - lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Liên Minh Châu Âu - Tiếng Malt - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - afatinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - giotrif bħala monoterapija hija indikata għat-trattament ofepidermal growth factor receptor (egfr) tki pazjenti adulti naΐve għal kura bil-lokalment avvanzat jew dak metastatiku li mhux ta 'ċelluli żgħar kanċer tal-pulmun (nsclc) ma' l-attivazzjoni tal-egfr-mutazzjoni tal - (s);lokalment avvanzat jew metastatiku nsclc tal-kanser skwamuż tar-istoloġija tal-progress fuq jew wara ibbażat fuq il-platinu ' kimoterapija.

Liên Minh Châu Âu - Tiếng Malt - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult 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. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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 dfsp. 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. .

Liên Minh Châu Âu - Tiếng Malt - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. , l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. imatinib actavis is indicated for: , 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 dfsp. l-esperjenza b'imatinib f'pazjenti b'mds/mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna. m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.