Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - bevacizumab - carcinoma, non-small-cell lung; breast neoplasms; ovarian neoplasms; colorectal neoplasms; 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 kif tal-bniedem tar-riċettur tal-fattur tat-tkabbir epidermali 2 (her2) status. 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. pazjenti li rċivew korsijiet li fihom taxxaane u anthracycline fl-istabbiliment awżiljarju fl-aħħar 12-il xahar għandhom jiġu esklużi mit-trattament b'avastin flimkien ma 'capecitabine. għal aktar informazzjoni dwar her2-istatus. bevacizumab, 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. 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 f'kombinazzjoni ma 'interferon alfa-2a huwa indikat għall-ewwel linja tal-kura ta' pazjenti adulti b'avvanzat u/jew metastatiku taċ-ċelluli renali kanċer. bevacizumab, 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) stadji iii b, iii u iv) ta 'l-epitilju ta' l-ovarji, l-tubu fallopjan, jew primarja peritoneali-kanċer. bevacizumab, f'kombinazzjoni ma 'carboplatin u gemcitabine, 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. bevacizumab f'kombinazzjoni ma 'paclitaxel, topotecan, jew pegylated liposomal doxorubicin huwa indikat għat-trattament ta' pazjenti adulti bil-platinu-reżistenti rikorrenti ta 'l-epitilju ta' l-ovarji, l-tubu fallopjan, jew primarja peritoneali-kanċer li ma rċeviet l-ebda aktar minn żewġ qabel ma 'korsijiet ta' kimoterapija u li qatt ma kienu rċevew terapija minn qabel ma 'bevacizumab, jew l-oħra' impedituri vegf jew vegf–riċetturi fil-mira l-aġenti. 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)

celltrion healthcare hungary kft. - 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 - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. vegzelma in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. vegzelma, 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 (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, 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 iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. vegzelma, 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 vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma 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 (see section 5. vegzelma, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - insulin aspart - diabetes mellitus - drogi użati fid-dijabete - truvelog mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - glecaprevir, pibrentasvir - epatite Ċ, kronika - antivirali għal użu sistemiku - maviret is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults and children aged 3 years and older. maviret coated granules is indicated for the treatment of chronic hepatitis c virus (hcv) infection in children 3 years and older.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - capecitabine - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - aġenti antineoplastiċi - capecitabine accord huwa indikat għat-trattament awżiljarju ta 'pazjenti wara l-kirurġija ta' stadju iii (dukes 'stage-c) kanċer tal-kolon. capecitabine qbil huwa indikat għat-trattament tal-kanċer metastatiku tal-kolorektum. capecitabine qbil huwa indikat għall-kura preferita tal-kanċer gastriku avvanzat flimkien ma ' reġim ibbażat fuq il -. capecitabine qbil 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 qbil 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

krka, d.d., novo mesto - capecitabine - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - aġenti antineoplastiċi - ecansya huwa indikat għat-trattament awżiljarju ta 'pazjenti wara kirurġija ta' stadju iii (dukes 'stage-c) kanċer tal-kolon. ecansya huwa indikat għat-trattament tal-kanċer metastatiku tal-kolorektum. ecansya huwa indikat għall-kura preferita tal-kanċer gastriku avvanzat flimkien ma ' reġim ibbażat fuq il -. ecansya 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. ecansya 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - aġenti antineoplastiċi - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

nordic group b.v. - tegafur, gimeracil, oteracil - neoplażmi fl-istonku - aġenti antineoplastiċi - teysuno is indicated in adults:- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5. - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - panitumumab - neoplażmi kolorettali - aġenti antineoplastiċi - vectibix is indicated for the treatment of adult patients with wild-type ras metastatic colorectal cancer (mcrc): , in first-line in combination with folfox or folfiri. , fil-tieni linja f'kombinazzjoni ma ' folfiri għall-pazjenti li rċevew l-ewwel linja bbażata fuq fluoropyrimidine-kimoterapija (esklużi l-irinotecan). , bħala monoterapija wara falliment ta 'l-fluworopirimidina, oxaliplatin u irinotecan-korsijiet ta' kimoterapija li fiha.