Vfend Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

vfend

pfizer europe ma eeig - voriconazole - candidiasis; mycoses; aspergillosis - antimikotiċi għal użu sistemiku - voriconazole, huwa triazole bi spettru wiesa'li aġent antifungali u hija indikata fl-adulti u t-tfal b'età minn 2 snin u l-fuq kif ġej:trattament ta 'asperġillożi invażiva;it-trattament tal fil-candidaemianon-pazjenti 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. vfend għandu jingħata primarjament lil pazjenti b'progressiva, possibbilment ta'theddida għall-ħajja infezzjonijiet. profilassi ta ' infezzjonijiet fungali invażivi f'riskju għoli alloġeneiċi trapjant ta'ċelloli staminali ematopojetiċi (hsct) riċevituri.

Inlyta Umoja wa Ulaya - Kimalta - 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.

Imfinzi Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

imfinzi

astrazeneca ab - durvalumab - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Imjudo Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

imjudo

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - aġenti antineoplastiċi - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc). imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Fotivda Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

fotivda

recordati netherlands b.v. - tienzanib - karċinoma, Ċellula renali - aġenti antineoplastiċi - fotivda huwa indikat għall-ewwel trattament linja ta ' l-adulti pazjenti b ' karċinoma taċ-ċelluli renali avvanzati (rcc) u għall-pazjenti adulti li huma vegfr u mtor il-mogħdija inhibitor-naïve wara progressjoni tal-marda wara t-trattament minn qabel waħda ma cytokine terapija għall rcc avvanzati. it-trattament ta ' karċinoma taċ-ċellola renali.

Afinitor Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

afinitor

novartis europharm limited - everolimus - carcinoma, renal cell; breast neoplasms; pancreatic neoplasms - aġenti antineoplastiċi - l-ormon tat-riċettur pożittiva tas-sider avvanzat cancerafinitor huwa indikat għall-kura ta 'l-ormon tat-riċettur-pożittivi, her2/neu negattivi għall-kanċer tas-sider avvanzat, f'kombinazzjoni ma exemestane, fil-nisa wara l-menopawsa mingħajr sintomatika vixxerali-marda wara l-rikorrenza jew l-progressjoni wara mediċini mhux sterojdi ta' inibitur aromatase. newroendokrinika tumuri tal-frixa originafinitor huwa indikat għall-kura ta li ma jistgħax jitneħħa kirurġikament, jew li mmetastatizza, sew jew moderatament differenzjati newroendokrinika tumuri tal-frixa-oriġini fl-adulti bil-marda progressiva. newroendokrinika tumuri tal-gastro-intestinali jew tal-pulmun originafinitor huwa indikat għall-kura ta li ma jistgħax jitneħħa kirurġikament, jew li mmetastatizza, differenzjat tajjeb (grad 1 jew ta ' grad 2) mhux funzjonali newroendokrinika tumuri tal-gastro-intestinali jew tal-pulmun-oriġini fl-adulti bil-marda progressiva. renali taċ-ċelluli carcinomaafinitor huwa indikat għall-kura ta ' pazjenti b'indeboliment avanzat tal-karċinoma taċ-ċellola, li l-marda tagħhom mexa fuq jew wara l-kura bil-vegf-terapija fil-mira.

Kisplyx Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

kisplyx

eisai gmbh - lenvatinib mesilate - karċinoma, Ċellula renali - aġenti antineoplastiċi - kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (rcc):in combination with pembrolizumab, as first-line treatment (see section 5. in combination with everolimus, following one prior vascular endothelial growth factor (vegf)-targeted therapy.

Tecentriq Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

tecentriq

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.

Vocabria Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

vocabria

viiv healthcare b.v. - cabotegavir sodium, cabotegravir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically suppressed (hiv-1 rna.

Darunavir Mylan Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

darunavir mylan

mylan pharmaceuticals limited - darunavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):għat-trattament ta ' l-hiv-1 infezzjoni fil-kura antiretrovirali (art)-l-esperjenza f'pazjenti adulti, inklużi dawk li ġew ħafna ttrattati minn qabel. għat-trattament ta 'l-hiv-1 infezzjoni fil-pazjenti pedjatriċi mill-eta' ta 3 snin u mill-inqas 15-il kg piż tal-ġisem. id-deċiżjoni li jinbeda it-trattament b'darunavir amministrat 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. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 u 5. darunavir amministrat flimkien ma 'doża baxxa ta' ritonavir huwa indikat, flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' pazjenti bil-vajrus tal-immunodefiċjenza umana (hiv-1) .  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. id-deċiżjoni li jinbeda it-trattament b'darunavir f'dawn l-arti-pazjenti b'esperjenza, ġenotipika l-ittestjar għandu jiggwida l-użu ta ' darunavir (ara sezzjonijiet 4. 2, 4. 3, 4. 4 u 5.