Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 u 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 u 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - orkambi b'rita huma ndikati għall-kura ta 'fibrożi ċistika (cf) fl-pazjenti ta' bejn 6 snin u ikbar li omozigoti għall-f508del mutazzjoni fil-cftr ġene. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - aġenti antineoplastiċi - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - fibrożi ċistika - prodotti oħra tas-sistema respiratorja - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulin human - diabetes mellitus - drogi użati fid-dijabete - dijabete mellitus fejn huwa meħtieġ it-trattament bl-insulina. insuman rapid huwa wkoll adattat għall-kura ta 'koma ipergliċemika u ketoaċidożi, kif ukoll għall-kisba ta' stabilizzazzjoni minn qabel, intra u wara l-operazzjoni f'pazjenti bid-dijabete mellitus.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ipsen pharma - cabozantinib - neoplażmi tat-tirojde - aġenti antineoplastiċi - trattament ta 'pazjenti adulti b'karċinoma medjulari tat-tirojde progressiva, li ma tistax tiġi mneħħija lokalment jew metastatika.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

dompé biotec s.p.a. - darbepoetin alfa - kidney failure, chronic; anemia; cancer - preparazzjonijiet antianemiċi - kura ta 'anemija sintomatika assoċjata ma' insuffiċjenza renali kronika (crf) f'adulti u pazjenti pedjatriċi. kura ta ' anemija sintomatika f'pazjenti adulti bil-kanċer tumuri malinni mhux majelojdi li qed jirċievu l-kimoterapija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig - bevacizumab - colorectal neoplasms; breast neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - zirabev flimkien ma 'kimoterapija bbażata fuq fluoropyrimidine huwa indikat għall-kura ta' pazjenti adulti b'karċinoma metastatika tal-kolon jew tar-rektum. zirabev 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. zirabev, 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. zirabev flimkien ma 'interferon alfa-2a huwa indikat għall-ewwel linja tal-kura ta' pazjenti adulti b'avvanzat u/jew metastatiku taċ-ċelluli renali kanċer. zirabev, 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.