Opzelura Unjoni Ewropea - Malti - EMA (European Medicines Agency)

opzelura

incyte biosciences distribution b.v. - ruxolitinib phosphate - vitiligo - preparazzjonijiet oħra dermatoloġiċi - opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Jakavi Unjoni Ewropea - Malti - EMA (European Medicines Agency)

jakavi

novartis europharm limited - ruxolitinib (bħala fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - aġenti antineoplastiċi - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. poliċitemija vera (pv)jakavi huwa indikat għall-kura ta ' pazjenti adulti b'poliċitemija vera li huma reżistenti jew intolleranti għal hydroxyurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Inrebic Unjoni Ewropea - Malti - EMA (European Medicines Agency)

inrebic

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - aġenti antineoplastiċi - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Yescarta Unjoni Ewropea - Malti - EMA (European Medicines Agency)

yescarta

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - aġenti antineoplastiċi - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy. yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Sunitinib Accord Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sunitinib accord

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - aġenti antineoplastiċi - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Sutent Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sutent

pfizer limited - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - aġenti antineoplastiċi - gastrointestinal stromal tumour (gist)sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. experience with sutent as first-line treatment is limited (see section 5.

Inlyta Unjoni Ewropea - Malti - EMA (European Medicines Agency)

inlyta

pfizer europe ma eeig  - axitinib - karċinoma, Ċellula renali - inibituri tal-proteina kinase - inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) after failure of prior treatment with sunitinib or a cytokine.

Stivarga Unjoni Ewropea - Malti - EMA (European Medicines Agency)

stivarga

bayer pharma ag - regorafenib - neoplażmi kolorettali - antineoplastic agents, protein kinase inhibitors - stivarga huwa indikat bħala monoterapija għall-kura ta ' pazjenti adulti bil:kanċer metastatiku tal-kolorektum (crc) li kienu kkurati minn qabel b', jew mhumiex ikkunsidrati li huma kandidati għall, disponibbli terapiji - dawn jinkludu kimoterapija bbażata fuq fluoropyrimidine, kontra l-vegf-terapija u anti-egfr-terapija;li ma jistgħax jitneħħa kirurġikament, jew li mmetastatizza tumuri stromali gastro-intestinali (gist) li mexa fuq jew li huma intolleranti għal qabel għal trattament b'imatinib u sunitinib;karċinoma epatoċellulari (hcc) li kienu kkurati minn qabel b'sorafenib.

Yervoy Unjoni Ewropea - Malti - EMA (European Medicines Agency)

yervoy

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - aġenti antineoplastiċi - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 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 (see sections 4. 4 u 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab 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. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab 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 (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab 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%.

Voriconazole Accord Unjoni Ewropea - Malti - EMA (European Medicines Agency)

voriconazole accord

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.