Európska únia - maltčina - EMA (European Medicines Agency)

novartis europharm limited - inclisiran - hypercholesterolemia; dyslipidemias - aġenti li jimmodifikaw il-lipidi - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin, oralone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Európska únia - maltčina - EMA (European Medicines Agency)

ratiopharm gmbh - leflunomide - artrite, rewmatika - immunosoppressanti - leflunomide huwa indikat għall-kura ta ' pazjenti adulti bil:artrite rewmatika attiva bħala 'mard tal-anti-rewmatiċi li jimmodifikaw il-mediċina' (dmard);artrite psorjatika attiva. riċenti jew fl-istess waqt it-trattament b'tossiku għall-fwied jew haematotoxic dmards (e. methotrexate) jista 'jirriżulta f'riskju akbar ta' reazzjonijiet avversi serji; għalhekk, il-bidu tat-trattament ta 'leflunomide għandu jiġi kkunsidrat bir-reqqa fir-rigward ta' dawn l-aspetti ta 'benefiċċju / riskju. barra minn hekk, il-qlib minn leflunomide għal dmard ieħor, mingħajr wara l-proċedura tat-tneħħija jistgħu wkoll iżidu r-riskju ta ' reazzjonijiet avversi serji anke għal żmien twil wara l-qlib tal -.

Európska únia - maltčina - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - capecitabine - stomach neoplasms; breast neoplasms; colonic neoplasms; colorectal neoplasms - capecitabine - capecitabine huwa indikat għat-trattament awżiljarju ta 'pazjenti wara kirurġija ta' stadju iii (dukes 'stage-c) kanċer tal-kolon. capecitabine huwa indikat għat-trattament tal-kanċer metastatiku tal-kolorektum. capecitabine huwa indikat għall-kura preferita tal-kanċer gastriku avvanzat flimkien ma ' reġim ibbażat fuq il -. capecitabine flimkien ma 'docetaxel huwa indikat għall-kura ta' pazjenti b'lokalment avvanzat jew tal-kanċer tas-sider metastatiku wara l-falliment tal-kimoterapija ċitotossika. it-terapija ta 'qabel kellha tinkludi anthracycline. capecitabine huwa wkoll indikat bħala monoterapija għall-kura ta 'pazjenti b'lokalment avvanzat jew tal-kanċer tas-sider metastatiku wara l-falliment ta' taxanes u ta 'kors ta' kimoterapija li fihom jew li għalihom l-aktar anthracycline ma tkunx indikata t-terapija.

Európska únia - maltčina - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sonidegib difosfat - karċinoma, Ċellula basal - aġenti antineoplastiċi - odomzo huwa indikat għat-trattament ta 'pazjenti adulti b'karċinoma taċ-ċelluli bażali lokalment avvanzati (bcc) li mhumiex suġġetti għal kirurġija ta' kura jew terapija bir-radjazzjoni.

Európska únia - maltčina - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - tipranavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - aptivus, mogħti flimkien ma 'doża baxxa ta' ritonavir, huwa indikat għall-kombinazzjoni antiretrovirali tat-trattament ta ' l-hiv-1 infezzjoni fil ħafna ttrattati minn qabel adulti u adolexxenti minn 12-il sena jew akbar fl-età bil-virus reżistenti għall-inibituri ta'proteasi multipliċi. aptivus għandu jintuża biss bħala parti minn attiva antiretrovirali kombinata-dożaġġ f'pazjenti bl-ebda għażliet terapewtiċi oħra. din l-indikazzjoni hija bbażata fuq ir-riżultati ta 'żewġ studji ta' fażi iii, magħmul f'ħafna ttrattati minn qabel pazjenti adulti (numru medjan ta '12-il qabel ma' aġenti antiretrovirali) bil-virus reżistenti għall-inibituri tal-protease u tal-fażi ii studju li investiga l-farmakokinetika, is-sigurtà u l-effikaċja ta ' aptivus fil-aktar li esperjenzaw it-trattament-pazjenti adolexxenti minn 12 sa 18-il sena. id-deċiżjoni li jinbeda it-trattament b'aptivus, mogħti flimkien ma 'doża baxxa ta' ritonavir, għandha tingħata konsiderazzjoni kbira lill-istorja tat-trattament tal-pazjent individwali u l-mudelli ta 'tibdiliet ġenetiċi assocjati ma' mediċini differenti. testijiet ġenotipiċi u finotipiċi (fejn disponibbli) u l-istorja tat-trattament għandhom jiggwidaw l-użu ta ' aptivus. il-bidu tat-trattament għandu jqis il-kombinazzjonijiet ta 'mutazzjonijiet li jistgħu jikkaġunaw impatt ta' rispons nagattiv għal aptivus, mogħti flimkien ma 'doża baxxa ta' ritonavir.

Európska únia - maltčina - 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.

Európska únia - maltčina - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin, linagliptin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - glyxambi, taħlita fissa tad-doża ta empagliflozin u linagliptin, huwa indikat f'adulti ta ' 18-il sena u akbar b'dijabete mellitus tip 2:biex ittejjeb il-kontroll gliċemiku meta metformin u/jew mediċina tat-tip sulphonylurea (su) u waħda mill-monokomponenti tal-glyxambi ma jipprovdux kontroll gliċemiku adegwat;meta diġà qegħdin jiġu ttrattati bil-kombinazzjoni ħielsa ta empagliflozin u linagliptin.

Európska únia - maltčina - EMA (European Medicines Agency)

roche registration gmbh - saquinavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - invirase huwa indikat għall-kura ta 'pazjenti adulti infettati bl-hiv-1. invirase għandu jingħata biss flimkien ma 'ritonavir u prodotti mediċinali antiretrovirali oħra.

Európska únia - maltčina - 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).

Európska únia - maltčina - EMA (European Medicines Agency)

amarin pharmaceuticals ireland limited - icosapent ethyl - dyslipidemias - aġenti li jimmodifikaw il-lipidi - indicated to reduce cardiovascular risk as an adjunct to statin therapy.