Europos Sąjunga - maltiečių - EMA (European Medicines Agency)

recordati rare diseases - osilodrostat phosphate - is-sindromu ta 'cushing - kortikosterojdi għal użu sistemiku - isturisa huwa indikat għall-kura ta ' l-sindromu ta'cushing fl-adulti.

Europos Sąjunga - maltiečių - EMA (European Medicines Agency)

dendreon uk ltd - awtologi periferali-ċelluli tad-demm lewkoċciti mononukleari inklużi minimu ta ' 50 miljun cd54 + għaċ-ċelloli awtoloġiċi attivat b'fattur fosfataŻi aċidu prostatic granulocyte-macrophage-istimulazzjoni tal-kolonja - neoplasmi prostatiċi - immunostimulanti oħrajn - provenge huwa indikat għat-trattament ta 'kanċer tal-prostata mhux sintomatiku sintomatiku jew sintomatiku metastatiku (mhux vixxerali) f'adulti maskili li fihom il-kemjoterapija għadha mhix indikata klinikament.

Europos Sąjunga - maltiečių - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - awtologi taċ-ċelluli cd34+ arrikkit-popolazzjoni li fiha l-trapjant ta ' ċelloli staminali transduced mal-lentiglobin bb305 lentiviral vector kodifikazzjoni il-beta-a-t87q-emoglobina ġene - beta-talassimja - other hematological agents - zynteglo huwa indikat għall-kura tal-pazjenti ta'12-il sena u akbar bi dipendenti mit-trasfużjoni β-talessimja (tdt) li ma jkollhomx β0/β0-ġenotip, li għalihom il-ċelluli staminali ematopojetiċi (hsc) trapjant huwa xieraq iżda tal-lewkoċiti tal-bniedem l-antiġen (hla) mqabbla relatati hsc tad-donaturi mhux disponibbli.

Europos Sąjunga - maltiečių - EMA (European Medicines Agency)

eurogenerics holdings b.v. - teriparatide - l-osteoporożi - homeostasi tal-kalċju - qutavina is indicated in adults. trattament ta 'l-osteoporożi f'nisa wara l-menopawża u fl-irġiel b'riskju akbar ta' ksur. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. trattament ta 'osteoporożi assoċjat ma sostnut sistemika terapija bi glukokortikojdi f'nisa u l-irġiel f'riskju akbar ta' ksur.

Europos Sąjunga - maltiečių - EMA (European Medicines Agency)

janssen-cilag international nv - apalutamide - neoplasmi prostatiċi - terapija endokrinali - erleada huwa indikat:fl-irġiel adulti għal kura ta ' mhux metastatiku-kastrazzjoni reżistenti għall-kanċer tal-prostata (nmcrpc) li huma f'riskju għoli li jiżviluppaw mard metastatiku. fl-irġiel adulti għal kura tal-kanċer metastatiku tal-ormon tat-sensittivi għall-kanċer tal-prostata (mhspc) flimkien mal-privazzjoni tal-androgen-terapija (adt).

Europos Sąjunga - maltiečių - EMA (European Medicines Agency)

astellas pharma europe b.v. - enzalutamide - neoplasmi prostatiċi - terapija endokrinali - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Europos Sąjunga - maltiečių - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - prostatika neoplażmi, il-kastrazzjoni-reżistenti - aġenti antineoplastiċi - treatment of adult patients with prostate cancer.

Europos Sąjunga - maltiečių - 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.

Europos Sąjunga - maltiečių - EMA (European Medicines Agency)

n.v. organon - corifollitropin alfa - reproductive techniques, assisted; ovulation induction; investigative techniques - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - controlled ovarian stimulation (cos) in combination with a gnrh antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (art) program. elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human chorionic gonadotropin (hcg).

Europos Sąjunga - maltiečių - EMA (European Medicines Agency)

astrazeneca ab - olaparib - neoplażmi fl-ovarji - aġenti antineoplastiċi - ta 'l-ovarji cancerlynparza huwa indikat bħala monoterapija għall -: l-manteniment tat-trattament ta' pazjenti adulti b'avvanzat (medjevali stadji iii u iv) brca1/2 mutat (linja ġerminali u/jew somatiċi) ta 'grad għoli ta' l-epitilju ta 'l-ovarji, tubu fallopjan jew primarja peritoneali-kanċer li huma fir-rispons (sħiħa jew parzjali) wara t-tlestija ta' l-ewwel linja bbażata fuq il-platinu ' kimoterapija. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 u 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. il-pazjenti għandu jkollhom qabel kienu kkurati bil-anthracycline u taxane fil - (neo)adjuvant jew metastatiku-istabbiliment sakemm il-pazjenti li ma kienux tajbin għal dawn it-trattamenti (ara sezzjoni 5. pazjenti bl-ormon tat-riċettur (hr)-kanċer tas-sider posittiv għandu wkoll għamlu progress fuq jew wara qabel l-terapija endokrinali, jew jiġu kkunsidrati bħala mhux adattati għal terapija endokrinali. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.