Európai Unió - máltai - EMA (European Medicines Agency)

bayer ag - darolutamide - prostatika neoplażmi, il-kastrazzjoni-reżistenti - terapija endokrinali - nubeqa is indicated for the treatment of adult men with- non metastatic castration resistant prostate cancer (nmcrpc) who are at high risk of developing metastatic disease (see section 5. - metastatic hormone sensitive prostate cancer (mhspc) in combination with docetaxel and androgen deprivation therapy (see section 5.

Európai Unió - máltai - EMA (European Medicines Agency)

accord healthcare s.l.u. - cabazitaxel - prostatika neoplażmi, il-kastrazzjoni-reżistenti - aġenti antineoplastiċi - treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Európai Unió - máltai - EMA (European Medicines Agency)

accord healthcare s.l.u. - abiraterone acetate - neoplasmi prostatiċi - terapija endokrinali - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Európai Unió - máltai - 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.

Európai Unió - máltai - EMA (European Medicines Agency)

mylan ireland limited - abiraterone acetate - neoplasmi prostatiċi - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Európai Unió - máltai - EMA (European Medicines Agency)

krka, d.d., novo mesto - abiraterone acetate - neoplasmi prostatiċi - terapija endokrinali - abiraterone krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt) (see section 5. 1)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. 1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Európai Unió - máltai - EMA (European Medicines Agency)

sandoz gmbh - trastuzumab - breast neoplasms; stomach neoplasms - aġenti antineoplastiċi - treatment of metastatic and early breast cancer and metastatic gastric cancer (mgc).

Európai Unió - máltai - EMA (European Medicines Agency)

krka, d.d., novo mesto - irbesartan, hydrochlorothiazide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. din il-kombinazzjoni tad-doża fissa hija indikata f'pazjenti adulti li l-pressjoni tad-demm tagħhom mhix ikkontrollata b'mod adegwat fuq irbesartan jew hydrochlorothiazide waħdu.

Európai Unió - máltai - EMA (European Medicines Agency)

teva b.v.  - irbesartan, hydrochlorothiazide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. din il-kombinazzjoni ta 'doża fissa hija indikata f'pazjenti adulti li l-pressjoni tad-demm tagħhom mhix ikkontrollata b'mod adegwat fuq irbesartan jew hydrochlorothiazide waħdu.

Európai Unió - máltai - EMA (European Medicines Agency)

dompé biotec s.p.a. - pegfilgrastim - neutropenia; cancer - immunostimulanti, - tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti trattati ma chemotherapy ċitotossiċi għall-malignancy (bl-eċċezzjoni ta ' kronika myeloid lewċemja u myelodysplastic sindromi).