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

lextemy

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.

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

keytruda

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - aġenti antineoplastiċi - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pazjenti b'egfr jew alkalini pożittivi tat-tumur mutazzjonijiet għandu wkoll rċevew terapija immirata qabel ma tirċievi keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

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

nexavar

bayer ag - sorafenib - carcinoma, hepatocellular; carcinoma, renal cell - aġenti antineoplastiċi - epatoċellulari carcinomanexavar huwa indikat għall-kura ta ' karċinoma epatoċellulari. taċ-ċelluli renali carcinomanexavar huwa indikat għall-kura ta ' pazjenti b'karċinoma taċ-ċellola renali li kellhom falliment ta qabel l-interferon-alpha jew interleukin-2 ibbażat fuq it-terapija jew li huma ikkunsidrati mhux tajba għal terapija bħal din. tat-tirojde differenzjat carcinomanexavar huwa indikat għall-kura ta ' pazjenti b'progressiva, lokalment avvanzat jew dak metastatiku, differenzjati (papillari/follikulari/hürthle taċ-ċelluli) karċinoma tat-tirojde, refrattarji għat-jodju radjuattiv.

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

sorafenib accord

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - aġenti antineoplastiċi - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5. renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

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

lytgobi

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - aġenti antineoplastiċi - lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

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

paxene

norton healthcare ltd. - paclitaxel - sarcoma, kaposi; carcinoma, non-small-cell lung; ovarian neoplasms; breast neoplasms - aġenti antineoplastiċi - paxene huwa indikat għall-kura ta 'pazjenti b':• avvanzati relatat mal-aids sarkoma ta'kaposi (aids-ks) li ma rnexxewx qabel anthracycline liposomali-terapija;• karċinoma metastatika ta'l-sider (mbc) li ma jkunux ħadmu jew ma jkunux-kandidati għall-istandard anthracycline-terapija li jkun fiha;• karċinoma avvanzata ta 'l-ovarji (aoc) jew bi residwu tal-marda (> 1 ċm) wara l-ewwel laparotomija, flimkien ma' cisplatin bħala l-ewwel linja ta 'trattament;• karċinoma metastatika ta' l-ovarju (moc) wara l-falliment ta jkun fihom il-platinu terapija kombinata mingħajr taxanes bħala t-tieni linja ta 'trattament;• non-small cell lung avvanzata (nsclc) li mhumiex kandidati għall-potenzjalment kurattiva-kirurġija u/jew terapija ta' radjazzjoni, flimkien ma ' cisplatin. dejta ta 'effikaċja limitata tappoġġja din l-indikazzjoni (ara sezzjoni 5.

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

masiviera

ab science - masitinib - neoplażmi pankreatiċi - inibituri tal-proteina kinase - it-trattament ta mhux resectable lokalment avvanzata jew metastatika tal-kanċer tal-frixa.

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

phesgo

roche registration gmbh - pertuzumab, trastuzumab - neoplażmi tas-sider - aġenti antineoplastiċi - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Tremelimumab AstraZeneca Unjoni Ewropea - Malti - EMA (European Medicines Agency)

tremelimumab astrazeneca

astrazeneca ab - tremelimumab - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - tremelimumab astrazeneca 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.

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

alimta

eli lilly nederland b.v. - pemetrexed - mesothelioma; carcinoma, non-small-cell lung - aġenti antineoplastiċi - plewrali malinna mesotheliomaalimta flimkien ma ' cisplatin huwa indikat għat-trattament tal-kimoterapija il-pazjenti naïve b'mesoteljoma plewrali malinna u li ma jistax jitneħħa. mhux żgħar tal-pulmun taċ-ċelluli canceralimta flimkien ma 'cisplatin huwa indikat għall-kura tal-ewwel linja ta' pazjenti b'lokalment avvanzat jew dak metastatiku li mhux żgħar tal-pulmun taċ-ċelloli tal-kanċer l-oħra mill-aktar istoloġija ta ' ċelluli skwamużi. alimta huwa indikat bħala monoterapija għall-kura ta 'manteniment ta lokalment avvanzat jew dak metastatiku li mhux żgħar tal-pulmun taċ-ċelloli tal-kanċer l-oħra mill-aktar istoloġija ta' ċelluli skwamużi fir-pazjenti li l-marda tagħhom ma jkunx hemm progress immedjatament wara ibbażat fuq il-platinu ' kimoterapija. alimta huwa indikat bħala monoterapija għall-tieni linja ta 'trattament ta' pazjenti b'lokalment avvanzat jew dak metastatiku li mhux żgħar tal-pulmun taċ-ċelloli tal-kanċer l-oħra mill-aktar istoloġija ta ' ċelluli skwamużi.