Union européenne - maltais - EMA (European Medicines Agency)

orphelia pharma sas - vigabatrin - spasms, infantile; epilepsies, partial - anti-epilettiċi, - kigabeq huwa indikat fit-trabi u fit-tfal minn xahar 1 għal inqas minn 7 snin ta ' età:it-trattament bil-monoterapija ta infantili spażmi (punent tal-sindromu). it-trattament flimkien ma ' prodotti mediċinali anti-epilettiċi għall-pazjenti b'reżistenti għall-epilessija parzjali (fokali aċċessjonijiet) bi jew mingħajr ġeneralizzazzjoni sekondarja, li huwa fejn l-oħra kollha xierqa il-prodott mediċinali kombinazzjonijiet kienu inadegwati jew ma ġiet ittollerata.

Union européenne - maltais - EMA (European Medicines Agency)

csl behring gmbh - lonoctocog alfa - hemofilja a - sustanzi kontra l-emorraġija - trattament u profilassi ta 'fsada f'pazjenti b'emofilja a (nuqqas konġenitali ta' fattur viii). afstyla jistgħu jiġu użati għall-gruppi kollha tal-età.

Union européenne - maltais - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - avanafil - disfunzjoni erettili - drogi użati f'każ ta 'disfunzjoni erettili - trattament ta 'disfunzjoni erettili f'irġiel adulti. sabiex spedra ikun effettiv, hija meħtieġa stimulazzjoni sesswali.

Union européenne - maltais - EMA (European Medicines Agency)

pfizer europe ma eeig - talazoparib - neoplażmi tas-sider - aġenti antineoplastiċi - talzenna huwa indikat bħala monoterapija għall-kura ta ' pazjenti adulti bil-linja ġerminali brca1/2 mutazzjonijiet, li għandhom her2-negattivi avvanzat lokalment jew metastatiku tas-sider kanċer. patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. pazjenti bl-ormon tat-riċettur (hr)-kanċer tas-sider posittiv għandhom kienu ttrattati minn qabel endokrinali bbażata fuq it-terapija, jew jiġu kkunsidrati bħala mhux tajbin għall-endokrinali-terapija bbażata fuq.

Union européenne - maltais - 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.

Union européenne - maltais - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - aġenti antineoplastiċi - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq bħala monoterapija hija indikata għat-trattament ta ' pazjenti adulti b'lokalment avvanzat jew metastatiku nsclc wara l-kimoterapija qabel. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq bħala monoterapija hija indikata għat-trattament ta ' pazjenti adulti b'lokalment avvanzat jew metastatiku nsclc wara l-kimoterapija qabel. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Union européenne - maltais - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - umeclidinium bromide, vilanterol trifenatate - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - anoro ellipta huwa indikat bħala l-manutenzjoni bronkodilatur-kura biex ittaffi s-sintomi fil-pazjenti adulti bil-marda pulmonari ostruttiva kronika (copd).

Union européenne - maltais - EMA (European Medicines Agency)

itm medical isotopes gmbh - lutetium (177lu) chloride - radjonuklidi imaging - radjofarmaċewtiċi terapewtiċi - endolucinbeta huwa prekursur radjofarmaċewtiku, u mhuwiex maħsub għal użu dirett f'pazjenti. għandha tintuża biss għar-radjutikkettar ta 'molekuli ta' trasport li ġew żviluppati u awtorizzati speċifikament għal radjutikkettar bil-klorur tal-lutetju (177lu).

Union européenne - maltais - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - umeclidinium bromide, vilanterol - mard tal-pulmun, obstructive kronika - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - laventair ellipta huwa indikat bħala l-manutenzjoni bronkodilatur-kura biex ittaffi s-sintomi fil-pazjenti adulti bil-marda pulmonari ostruttiva kronika (copd).

Union européenne - maltais - 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.