Unjoni Ewropea - Malti - EMA (European Medicines Agency)

elanco gmbh - benazepril hydrochloride, pimobendan - inibituri ace, kombinazzjonijiet - klieb - għall-kura ta 'insuffiċjenza tal-qalb konġestiva minħabba insuffiċjenza ta' valv atrijoventrikulari jew kardjomijopatija dilwita fil-klieb.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - cinacalcet hydrochloride - hypercalcemia; parathyroid neoplasms; hyperparathyroidism - homeostasi tal-kalċju - sekondarja hyperparathyroidismadultstreatment ta 'iperparatirojdiżmu sekondarju (hpt) f'pazjenti adulti bl-aħħar stadju ta' mard renali (esrd) fuq l-manutenzjoni terapija b'dijalisi. pedjatriċi populationtreatment ta 'iperparatirojdiżmu sekondarju (hpt) fit-tfal ta' 3 snin u ikbar bl-aħħar stadju ta ' mard renali (esrd) fuq l-manutenzjoni terapija b'dijalisi li hpt sekondarja mhux ikkontrollata sew bl-istandard tal-kura it-terapija. mimpara jista 'jintuża bħala parti minn kors terapewtiku li jinkludi binders tal-fosfat u/jew sterols ta' vitamina d, kif xieraq. karċinoma tal-paratirojde u iperparatirojdiżmu primarju fl-adulti. tnaqqis ta 'iperkalċimja f'pazjenti adulti bil:karċinoma tal-paratirojde;hpt primarja fejn paratirojdektomija għanda tkun indikata fuq il-bażi tal-livelli tal-kalċju fis-serum (kif definit mil-linji gwida ta' kura rilevanti), iżda fejn paratirojdektomija mhiex klinikament xierqa jew kontraindikata.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - ropeginterferon alfa-2b - polycythemia vera - immunostimulanti, - besremi huwa indikat bħala monoterapija fl-adulti għat-trattament ta ' poliċitemija vera mingħajr sintomatika splenomegalija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan pharmaceuticals limited - cinacalcet hydrochloride - hyperparathyroidism, secondary; hypercalcemia - homeostasi tal-kalċju - il-kura ta 'iperparatirojdiżmu sekondarju (hpt) f'pazjenti b'mard renali fl-aħħar stadju (esrd) fuq terapija ta' dijalisi ta 'manteniment. cinacalcet mylan jista 'jintuża bħala parti minn kors terapewtiku li jinkludi binders tal-fosfat u/jew sterols ta' vitamina d, kif xieraq. tnaqqis ta 'iperkalċimja f'pazjenti b': - paratirojde carcinomaprimary hpt li għalihom parathyroidectomywould tkun indikata fuq il-bażi tal-livelli tal-kalċju fis-serum (kif definit mil-linji gwida ta ' kura rilevanti), iżda fejn paratirojdektomija mhiex klinikament xierqa jew kontraindikata.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

acino pharma gmbh  - clopidogrel - mard vaskulari periferali - aġenti antitrombotiċi - clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta 'avvenimenti aterotrombotiċi f': pazjenti li jbatu minn infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard arterjali periferali. - pazjenti li jbatu mis-sindromu koronarju akut: mhux elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux tal-mewġa q 'infart mijokardijaku), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutanju, flimkien ma' acetylsalicylic acid (asa). l - elevazzjoni tas-segment st infart mijokardijaku akut, flimkien ma ' asa f'medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika. għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

acino pharma gmbh - clopidogrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - aġenti antitrombotiċi - clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta 'avvenimenti aterotrombotiċi f': pazjenti li jbatu minn infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard arterjali periferali;il-pazjenti li jbatu mis-sindromu koronarju akut:- nuqqas ta elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux-mewġa-q infart mijokardijaku), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutanju, flimkien ma ' acetylsalicylic acid (asa);l - elevazzjoni tas-segment st infart mijokardijaku akut, flimkien ma ' asa f'medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika. għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

eisai gmbh - eribulin - breast neoplasms; liposarcoma - aġenti antineoplastiċi - monoterapija b'halaven hija indikata għat-trattament ta 'pazjenti b'kanċer tas-sider lokalment avvanzat jew metastatiku li għamel progress wara mill-inqas korsijiet kemoterapewtiċi għal mard avvanzat (ara sezzjoni 5. terapija ta 'qabel kellha tinkludi anthracycline u taxane sakemm il-pazjenti ma kinux adattati għal dawn it-trattamenti. halaven huwa indikat għall-kura ta ' pazjenti adulti li ma jistax jitneħħa pazjenti b'liposarkoma li kienu rċevew qabel terapija li jkun fiha anthracycline (sakemm ma jkunux addattati) għall-marda avvanzata jew metastatika (ara sezzjoni 5.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biofrontera bioscience gmbh - idroklorur ta 'l-aċidu 5-aminolevuliniku - keratosis, actinic; carcinoma, basal cell - aġenti antineoplastiċi - it-trattament ta'keratosi aktinika ta ' severita ħafifa għal moderata fuq il-wiċċ u l-qorriegħa (olsen grad 1-2; ara t-taqsima 5. 1) u tal-qasam cancerization fl-adulti. it-trattament tal-superfiċjali u/jew nodular karċinoma taċ-ċellola bażali mhux tajbin għall-kura kirurġika minħabba possibbli relatati mal-kura-morbidità u/jew foqra kosmetiċi-eżitu fl-adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

acino pharma gmbh - clopidogrel - peripheral vascular diseases; stroke; myocardial infarction - aġenti antitrombotiċi - clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta 'avvenimenti aterotrombotiċi f': pazjenti li jbatu minn infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard arterjali periferali. għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.