Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration ltd. - daclizumab - graft rejection; kidney transplantation - immunosoppressanti - zenapax huwa indikat għall-profilassi ta ' rifjut ta ' l-organu akuta fil-de novo allogenic renali trapjant u għandha tintuża b'mod konkomitanti ma ' xi skoperta immunosuppressivi, inkluż cyclosporine u corticosteroids fil-pazjenti li huma ma immunised ħafna.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - tafasitamab - lymphoma, large b-cell, diffuse - aġenti antineoplastiċi - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).

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)

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)

viatris healthcare limited - tobramycin - cystic fibrosis; respiratory tract infections - antibatteriċi għal użu sistemiku, - tobi podhaler huwa indikat għat-terapija suppressiva ta 'infezzjoni pulmonari kronika minħabba pseudomonas aeruginosa fl-adulti u tfal ta' 6 snin 'il fuq b'fibrożi ċistika. ara t-taqsimiet 4. 4 u 5. 1 rigward data fi gruppi ta 'etajiet differenti. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

eurocept international b. v. - sodium phenylbutyrate - carbamoyl-fosfat synthase i marda defiċjenza - varji ta'l-apparat alimentari u tal-metaboliżmu-prodotti - it-trattament kroniku tal-ġestjoni tal-urea-disturbi fiċ-ċiklu.

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)

pfizer limited - celecoxib - polyposis adenomatous coli - aġenti antineoplastiċi - onsenal huwa indikat għat-tnaqqis tan-numru ta 'polipi intestinali adenomatosi f'poliposi adenomatuża familjali (fap), bħala żieda mal-kirurġija u sorveljanza endoskopika oħra (ara sezzjoni 4. l-effett tat-tnaqqis indott minn onsenal tal-piż tal-polipi fuq ir-riskju ta ' kanċer intestinali għadu ma ntweriex (ara sezzjonijiet 4. 4 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pharmathen s.a. - irbesartan - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - sabervel huwa indikat fl-adulti għat-trattament tal-ipertensjoni essenzjali. huwa wkoll indikat għall-kura tal-mard renali fil-pazjenti adulti bi pressjoni għolja u b'dijabete mellitus tip 2 bħala parti mill kontra l-pressjoni il-prodott mediċinali reġimen.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.