Uniunea Europeană - malteză - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - zoledronic acid - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - drogi għat-trattament ta 'mard tal-għadam - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture, including those with a recent low-trauma hip fracture. trattament ta ' osteoporożi assoċjat ma sistemiku fit-tul terapija bi glukokortikojdi fil-nisa wara l-menopawża u f'irġiel f'riskju akbar ta'ksur. it-trattament tal-marda ta'paget ta ' l-għadam.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - nelarabine - leukimija linfoblastika taċ-Ċelluli t prekursuri-linfoma - aġenti antineoplastiċi - nelarabine huwa indikat għat-trattament ta'pazjenti b't-cell acute lymphoblastic leukaemia (t-all) u b't-cell lymphoblastic lymphoma (t-lbl) li l-marda tagħhom ma tkunx wieġbet għal jew tkun reġgħet tfaċċat wara trattament b'għallinqas żewġ reġimens ta ' kimoterapija. due to the small patient populations in these disease settings, the information to support these indications is based on limited data.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

astellas pharma europe b.v. - mirabegron - bużżieqa ta 'l-awrina, Żejjed - uroloġiċi - trattament sintomatiku ta 'urġenza. Żieda fil-frekwenza biex tgħaddi l-awrina u / jew urġenza ta ' nkontinenza kif jistgħu jseħħu f'pazjenti adulti bil-attiva żżejjed-sindromu tal-bużżieqa.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

sandoz pharmaceuticals d.d. - topotecan - ovarian neoplasms; uterine cervical neoplasms; small cell lung carcinoma - aġenti antineoplastiċi - il-kapsuli ta 'hycamtin huma indikati bħala monoterapija għall-kura ta' pazjenti adulti b'kanċer tal-pulmun taċ-ċelluli ż-żgħar (sclc) li rkadew u li għalihom it-trattament mill-ġdid bir-reġimen ta 'l-ewwel linja mhuwiex ikkunsidrat xieraq. topotecan huwa indikat għall-kura ta 'pazjenti b'karċinoma metastatika ta'l-ovarji, wara l-falliment ta' l-ewwel linja jew wara t-terapija. il-kapsuli ta 'hycamtin huma indikati bħala monoterapija għall-kura ta' pazjenti adulti b'kanċer tal-pulmun taċ-ċelluli ż-żgħar (sclc) li rkadew u li għalihom it-trattament mill-ġdid bir-reġimen ta 'l-ewwel linja mhuwiex ikkunsidrat xieraq.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

astellas pharma europe b.v. - micafungin - kandidjasi - antimikotiċi għal użu sistemiku - mycamine hu indikat għal:l-adulti, adoloxxenti ≥ 16-il sena u elderlytreatment ta 'kandidjasi invażiva;trattament ta' kandidjasi esofagali f'pazjenti li għalihom hija xierqa terapija intravenuża;profilassi ta 'infezzjoni candida f'pazjenti li jkunu qed alloġeniċi ematopojetiċi trapjant taċ-ċelloli staminali jew pazjenti li jkunu mistennija li jkollhom newtropenja (għadd assolut ta' newtrofili < 500 ċellola/µl) għal 10 ijiem jew aktar. tfal (li jinkludu trabi li għadhom jitwieldu) u adoloxxenti < 16-il sena ta agetreatment ta ' kandidjasi invażiva. profilassi ta 'infezzjoni candida f'pazjenti li jkunu qed alloġeniċi ematopojetiċi trapjant taċ-ċelloli staminali jew pazjenti li jkunu mistennija li jkollhom newtropenja (għadd assolut ta' newtrofili < 500 ċellola/µl) għal 10 ijiem jew aktar. id-deċiżjoni jekk jintużax mycamine għandha tieħu in kunsiderazzjoni l-potenzjal tar-riskju għall-iżvilupp ta ' tumuri fil-fwied. għalhekk, mycamine għandu jintuża biss jekk antifungali oħrajn ma jkunux xierqa.

Uniunea Europeană - malteză - 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.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

astellas pharma europe b.v. - gilteritinib fumarate - lewkimja, mijelojda, akuta - aġenti antineoplastiċi - xospata huwa indikat bħala monoterapija għall-kura ta ' pazjenti adulti li rkadew jew refrattorji lewkimja majelojde akuta (aml) b'flt3 mutazzjoni.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

astellas pharma europe b.v. - roxadustat - anemia; kidney failure, chronic - preparazzjonijiet antianemiċi - evrenzo is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (ckd).

Uniunea Europeană - malteză - EMA (European Medicines Agency)

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - aġenti antineoplastiċi - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

Uniunea Europeană - malteză - EMA (European Medicines Agency)

stada arzneimittel ag - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - oftalmoloġiċi - ximluci is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).