Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxo group ltd. - amprenavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - agenerase, flimkien ma 'mediċini antiretrovirali oħra, huwa indikat għall-kura ta' impeditur protease (pi) b'esperjenza ta 'adulti infettati bl-hiv-1 u tfal' l fuq minn 4 snin. il-kapsuli ta 'agenerase għandhom normalment jiġu amministrati b'doża baxxa ta' ritonavir bħala stimulant farmakokinetiku ta 'amprenavir (ara sezzjonijiet 4. 2 u 4. l-għażla ta 'amprenavir għandha tkun ibbażata fuq ittestjar ta' reżistenza virali individwali u l-istorja tal-kura tal-pazjenti (ara sezzjoni 5. il-benefiċċju ta 'agenerase ma' ritonavir ma ntwerewx f'pi nave-pazjenti (ara sezzjoni 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - apixaban - venous thromboembolism; stroke; arthroplasty - aġenti antitrombotiċi - prevention of venous thromboembolic events (vte) in adult patients who have undergone elective hip or knee replacement surgery. il-prevenzjoni ta 'puplesija u emboliżmu sistematiku f'pazjenti adulti b'nuqqas valvulari fibrillazzjoni atrijali (nvaf), ma'wieħed jew aktar fatturi ta' riskju, bħal qabel puplesija jew attakk iskemiku temporanju (tia); età ≥ 75-il sena; pressjoni għolja; d-dijabete mellitus; insuffiċjenza tal-qalb sintomatika (nyha klassi ≥ ii). trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti (ara sezzjoni 4. 4 għall-emodinamikament instabbli pe pazjenti). prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (nvaf), with one or more risk factors, such as prior stroke or transient ischaemic attack (tia); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (nyha class ≥ ii). trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti (ara sezzjoni 4. 4 għall-emodinamikament instabbli pe pazjenti).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - voriconazole - aspergillosis; candidiasis; mycoses - antimikotiċi għall-użu sistemiku-derivattivi tat-triazole - voriconazole huwa aġent broad-spectrum, aġent antifungali triazole u hija indikata fl-adulti u t-tfal li għandhom sentejn u aktar kif ġej:trattament ta 'asperġillożi invażiva;it-trattament ta'candidaemia f'pazjenti mhux newtropeniċi;il-kura ta' fluconazole-'infezzjonijiet invażivi serji candida reżistenti (inkluż c. krusei);il-kura ta'infezzjonijiet fungali serji kkawżati minn scedosporium spp. u fusarium spp. voriconazole għandu jingħata primarjament lil pazjenti b'progressiva, possibbilment ta'theddida għall-ħajja infezzjonijiet.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen technology (ireland) uc - bevacizumab - carcinoma, renal cell; peritoneal neoplasms; ovarian neoplasms; breast neoplasms; carcinoma, non-small-cell lung; fallopian tube neoplasms - aġenti antineoplastiċi - mvasi flimkien ma ' bbażati fuq il-fluoropyrimidine chemotherapy huwa indikat għall-kura tal-pazjenti adulti b ' karċinoma metastatic ta-colon jew rectum. mvasi f'kombinazzjoni ma 'paclitaxel, huwa indikat għall-kura preferita ta' pazjenti adulti b'kanċer metastatiku tas-sider. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. mvasi, barra minn hekk 'kimoterapija bbażata fuq platinum, huwa ndikat għall-kura preferita ta' pazjenti adulti li ma jistax jitneħħa, avvanzat, li mmetastatizza jew rikorrenti taċ-ċelluli mhux żgħar tal-pulmun il-kanċer l-oħra mill-aktar istoloġija ta ' ċelluli skwamużi. mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. mvasi, f'kombinazzjoni ma 'carboplatin u paclitaxel huwa ndikat għall-quddiem il-linja ta 'trattament ta' pazjenti adulti b'avvanzati (il-federazzjoni internazzjonali tal-mard tal-ġilda u l-ostetriċja (medjevali) istadji iiib, iii u iv) ta 'l-epitilju ta' l-ovarji, l-tubu fallopjan, jew primarja peritoneali-kanċer. mvasi, f'kombinazzjoni ma 'carboplatin u gemcitabine jew f'kombinazzjoni ma' carboplatin u paclitaxel, huwa indikat għall-kura ta 'pazjenti adulti bil-ewwel rikorrenza tal-sensittiva għall-platinum ta' l-epitilju ta 'l-ovarji, l-tubu fallopjan jew primarja peritoneali-kanċer li ma rċevew terapija minn qabel ma' bevacizumab, jew l-oħra ' impedituri vegf jew vegf-riċetturi fil-mira l-aġenti. mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. mvasi, flimkien ma 'paclitaxel u cisplatin jew, alternattivament, paclitaxel u topotecan f'pazjenti li ma jistgħux jirċievu l-platinum-terapija, huwa indikat għall-kura ta' pazjenti adulti b'persistenti, rikorrenti, jew karċinoma metastatika taċ-ċerviċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration limited - emicizumab - hemofilja a - sustanzi kontra l-emorraġija - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype. hemlibra jistgħu jintużaw fil-gruppi kollha tal-età.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

eli lilly nederland b.v. - necitumumab - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - portrazza flimkien ma ' gemcitabine u cisplatin chemotherapy huwa indikat għall-kura ta ' adulti pazjenti li r-riċevitur avvanzat lokalment jew metastatic epidermiku fattur tat-tkabbir (egfr) li jesprimu l-kanċer tal-pulmun taċ-ċellola mhux-żgħar squamous li ma li jaslu chemotherapy minn qabel għal din il-kondizzjoni.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi oħra, inibituri tal-proteina kinase - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - aflibercept - neoplażmi kolorettali - aġenti antineoplastiċi - kura tal-kanċer metastatiku tal-kolorektum (mcrc).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

centus biotherapeutics europe limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - aġenti antineoplastiċi - bevacizumab flimkien ma 'kimoterapija bbażata fuq fluoropyrimidine huwa indikat għall-kura ta' pazjenti adulti b'karċinoma metastatika tal-kolon jew tar-rektum. bevacizumab f'kombinazzjoni ma 'paclitaxel, huwa indikat għall-kura preferita ta' pazjenti adulti b'kanċer metastatiku tas-sider. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. bevacizumab f'kombinazzjoni ma 'capecitabine huwa indikat għall-kura preferita ta' pazjenti adulti b'kanċer metastatiku tas-sider li fihom it-trattament bil-kimoterapija oħra għażliet inklużi l-tassani jew antraċiklini ma jkunx ikkunsidrat xieraq. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. bevacizumab, f'kombinazzjoni ma 'erlotinib, huwa indikat għall-kura preferita ta' pazjenti adulti li ma jistax jitneħħa, avvanzat, li mmetastatizza jew rikorrenti mhux squamous taċ-ċelluli mhux żgħar tal-pulmun il-kanċer mar-riċettur tal-fattur tat-tkabbir epidermali (egfr) mutazzjonijiet li jattivaw. bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. bevacizumab, flimkien ma 'paclitaxel u cisplatin jew, alternattivament, paclitaxel u topotecan f'pazjenti li ma jistgħux jirċievu l-platinum-terapija, huwa indikat għall-kura ta' pazjenti adulti b'persistenti, rikorrenti, jew karċinoma metastatika taċ-ċerviċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan ire healthcare limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.