Unjoni Ewropea - Malti - EMA (European Medicines Agency)

midas pharma gmbh - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - oftalmoloġiċi - ranivisio 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).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

curium pet france - piflufolastat (18f) - neoplasmi prostatiċi - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. pylclari is indicated for the detection of prostate-specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high-risk pca prior to initial curative therapy,to localize recurrence of pca in patients with a suspected recurrence based on increasing serum prostate-specific antigen (psa) levels after primary treatment with curative intent. pylclari is indicated for use with positron emission tomography (pet).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

hospira uk limited - docetaxel trihydrate - stomach neoplasms; prostatic neoplasms; breast neoplasms; head and neck neoplasms; carcinoma, non-small-cell lung - aġenti antineoplastiċi - tas-sider cancertaxespira flimkien ma 'doxorubicin u cyclophosphamide huwa indikat għall-kura awżiljarja ta' pazjenti bi:operabbli node-kanċer tas-sider posittiv;operabbli node negattivi għall-kanċer tas-sider. għall-pazjenti b'operabbli node negattivi għall-kanċer tas-sider, adjuvant it-trattament għandu jkun ristrett għal pazjenti eliġibbli li jirċievu l-kimoterapija skond internazzjonalment stabbiliti l-kriterji għall-primarja terapija tal-kanċer tas-sider bikri. taxespira flimkien ma 'doxorubicin huwa indikat għat-trattament ta' pazjenti b'avvanzat lokalment jew metastatiku tas-sider tal-kanċer li ma kinux ħadu qabel terapija ċitotossika għal din il-kundizzjoni. taxespira monoterapija hija indikata għat-trattament ta 'pazjenti b'lokalment avvanzat jew tal-kanċer tas-sider metastatiku wara l-falliment ta' terapija ċitotossika. kemjoterapija preċedenti kellha tinkludi anthracycline jew aġent alkilanti. taxespira flimkien ma 'trastuzumab huwa indikat għat-trattament ta' pazjenti b'kanċer tas-sider metastatiku li t-tumuri tagħhom fuq jesprimu her2, u li preċedentement ma kienux ħadu kimoterapija għall-mard metastatiku. taxespira flimkien ma 'capecitabine huwa indikat għat-trattament ta' pazjenti b'lokalment avvanzat jew tal-kanċer tas-sider metastatiku wara l-falliment tal-kimoterapija ċitotossika. it-terapija ta 'qabel kellha tinkludi anthracycline. taċ-ċelluli mhux żgħar tal-pulmun il-kanċer taxespira indikat għall-kura ta ' pazjenti b'lokalment avvanzat jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer wara l-falliment tal-kimoterapija qabel. taxespira flimkien ma 'cisplatin huwa indikat għat-trattament ta' pazjenti li ma jistax jitneħħa, avvanzat lokalment jew metastatiku taċ-ċelluli mhux żgħar tal-pulmun il-kanċer, f'pazjenti li ma kinux ħadu qabel terapija ċitotossika għal din il-kundizzjoni. kanċer tal-prostata taxespira flimkien ma 'prednisone jew prednisolone huwa indikat għat-trattament ta' pazjenti bl-ormon tat-refrattarji kanċer metastatiku tal-prostata. adenokarċinoma gastrika taxespira flimkien ma 'cisplatin u 5-fluorouracil huwa indikat għat-trattament ta' pazjenti b'adenokarċinoma gastrika metastatika, inkluż l-adenokarċinoma ta ' l-istonku junction, li ma ħadu l-kimoterapija qabel, għal mard metastatiku. - ras u l-għonq tal-kanċer taxespira flimkien ma 'cisplatin u 5-fluorouracil huwa indikat għat-trattament induttiv ta' pazjenti b'lokalment avvanzat tal-karċinoma b'ċelloli squamous tar-ras u l-għonq.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

advanced accelerator applications - edotreotide - neuroendocrine tumors; radionuclide imaging - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. wara l-radjutikkettar ma ' gallju (68ga) chloride, is-soluzzjoni tal-gallju (68ga) edotreotide miksuba huwa indikat għall-positron emission tomography (pet) tal-immaġini tal-somatostatin tar-riċettur tal-espressjoni żejda f'pazjenti adulti b'ikkonfermat jew suspettat differenzjat tajjeb gastro-enteropancreatic newroendokrinika tumuri (gep-net) għal lokalizzazzjoni primarja tumuri u l-metastasi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ge healthcare b.v. - ioflupane (123l) - tomography, emission-computed, single-photon; lewy body disease; parkinson disease; alzheimer disease - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. datscan huwa indikat għall-osservazzjoni telf tal-funzjonali tan-newroni dopaminerġiċi terminali fl-istriatum:f'pazjenti adulti b'klinikament inċerti u sindromi ta'parkinson, per eżempju dawk b'sintomi bikrija, biex jgħin jagħraf bejn tregħid essenzjali u sindromi ta'parkinson relatati mal-marda idjopatika ta ' parkinson, atrofija multipla tas-sistema u progressive supranuclear palsy. datscan huwa f'pożizzjoni li jiddistingwi bejn il-marda ta'parkinson, atrofija multipla tas-sistema u progressive supranuclear palsy. f'pazjenti adulti, li jgħin biex jiddistingwi-probabbiltà ta ' dimenzja b'lewy bodies mill-marda ta'alzheimer. datscan ma jistgħux jiddiskriminaw bejn dimenzja mal-korpi lewy u l-marda ta ' parkinson id-dimenzja.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ascendis pharma endocrinology division a/s - lonapegsomatropin - growth and development - ormoni u analogi pitwitarji u ipotalamiċi - growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [ghd]),.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

blue earth diagnostics ireland ltd - fluciclovine (18f) - prostatic neoplasms; radionuclide imaging - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. axumin huwa indikat għall-positron emission tomography (pet) tal-immaġini biex jidentifikaw ir-rikorrenza tal-kanċer tal-prostata fl-irġiel adulti b'suspett rikorrenza bbażata fuq l-għoli fid-demm antiġen speċifiku għall-prostata (psa) livelli wara l-ewwel trattament kurattiv.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

alnylam netherlands b.v. - givosiran - porphyrias, tal-fwied - varji ta'l-apparat alimentari u tal-metaboliżmu-prodotti - it-trattament ta akuta tal-fwied, porfirja (huma maħsuba) fl-adulti u adolexxenti minn 12-il sena u anzjani.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - radjonuklidi imaging - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.