Uni Eropa - Malta - EMA (European Medicines Agency)

novartis europharm limited  - vildagliptin, metformin hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - zomarist is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate.

Uni Eropa - Malta - EMA (European Medicines Agency)

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%.

Uni Eropa - Malta - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - atazanavir (as sulfate) - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - kapsoli reyataz, ko amministrati b ' doża baxxa ritonavir, huma indikati għat-trattament ta ' l-hiv-1 infettati adulti u pazjenti pedjatriċi 6 snin ta ' età u eqdem f'kombinazzjoni ma ' oħra prodotti mediċinali antiretroviral (ara taqsima 4. ibbażat fuq disponibbli viroloġiku u kliniku minn pazjenti adulti, m'hu mistenni ebda benefiċċju f'pazjenti b'razez reżistenti għall-inibituri ta'proteasi multipliċi (≥ 4 mutazzjonijet pi). l-għażla ta ' reyataz f'it-trattament bl-esperjenza fl-adulti u pazjenti pedjatriċi għandu jkun ibbażat fuq testijiet tar-reżistenza virali u l-istorja tat-trattament tal-pazjent (ara sezzjonijiet 4. 4 u 5. reyataz trab orali, mogħti flimkien ma 'doża baxxa ta' ritonavir, huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' l-hiv-1 pazjenti tfal infettati mill-anqas 3 xhur u li jiżnu mill-inqas 5 kg (ara sezzjoni 4. ibbażat fuq disponibbli viroloġiku u kliniku minn pazjenti adulti, m'hu mistenni ebda benefiċċju f'pazjenti b'razez reżistenti għall-inibituri ta'proteasi multipliċi ( 4 mutazzjonijet pi). l-għażla ta ' reyataz f'it-trattament bl-esperjenza fl-adulti u pazjenti pedjatriċi għandu jkun ibbażat fuq testijiet tar-reżistenza virali u l-istorja tat-trattament tal-pazjent (ara sezzjonijiet 4. 4 u 5.

Uni Eropa - Malta - 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.

Uni Eropa - Malta - EMA (European Medicines Agency)

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunostimulanti, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4. 4 u 5. paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. fir-rigward tal-deċiżjoni li tinbeda l-kura f'pazjenti pedjatriċi ara sezzjonijiet 4. 2, 4. 4 u 5. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4. 2, 4. 4 u 5. għall-vajrus tal-epatite Ċ (hcv) ġenotip attività speċifika, ara sezzjonijiet 4. 2 u 5. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. meta jiddeċiedu li tibda l-kura fit-tfulija, huwa importanti li tikkunsidra l-inibizzjoni tat-tkabbir indotta mill-terapija kombinata. l-riversibbiltà ta ' inibizzjoni tat-tkabbir huwa inċert. id-deċiżjoni li l-kura għandha tittieħed fuq bażi ta'każ b'każ (ara sezzjoni 4.

Uni Eropa - Malta - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - thalidomide - majloma multipla - immunosoppressanti - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

Uni Eropa - Malta - EMA (European Medicines Agency)

les laboratoires servier - pegaspargase - leukimija limfoblastika taċ-Ċelluli prekursuri-linfoma - aġenti antineoplastiċi - oncaspar huwa indikat bħala komponent ta 'terapija kombinata antineoplastika fil-lewkimja limfoblastika akuta (all) f'pazjenti pedjatriċi minn twelid sa 18-il sena, u pazjenti adulti.

Uni Eropa - Malta - EMA (European Medicines Agency)

merck sharp & dohme b.v. - peginterferon alfa-2b - epatite Ċ, kronika - immunostimulanti, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. jekk jogħġbok irreferi għall-ribavirin u boceprevir-sommarji tal-karatteristiċi tal-prodott (smpcs) meta pegintron ikun ser jintuża flimkien ma ' dawn il-mediċini. adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. pegintron f'kombinazzjoni ma 'ribavirin (bitherapy) huwa indikat għall-kura ta chc infezzjoni fil-pazjenti adulti li ma kienux trattati qabel inkluż pazjenti b'hiv klinikament stabbli ko-infezzjoni u f'pazjenti adulti li jkunu fallew it-trattament preċedenti bl-interferon-alpha (pegilata jew mhux pegilata) u terapija kombinata b'ribavirin jew ma' interferon-alpha monoterapija. il-monoterapija b'interferon, li tinkludi pegintron, tintuża l-aktar f'każ ta 'intolleranza jew ta' kontra-indikazzjoni għal ribavirin. jekk jogħġbok irreferi għall-ribavirin smpc meta pegintron ikun ser jintuża flimkien ma ' ribavirin. paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna. meta tiddeċiedi li ma li tipposponi it-trattament sakemm il-ħajja adulta, huwa importanti li wieħed jikkunsidra li l-terapija kombinata indotta-inibizzjoni tat-tkabbir li jista'jkun irriversibbli f'xi pazjenti. id-deċiżjoni li l-kura għandha tittieħed każ b'każ. jekk jogħġbok irreferi għall-ribavirin smpc għal kapsuli jew soluzzjoni orali meta pegintron ikun ser jintuża flimkien ma ' ribavirin.

Uni Eropa - Malta - EMA (European Medicines Agency)

roche registration gmbh - tocilizumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; cytokine release syndrome; giant cell arteritis; covid-19 virus infection - immunosoppressanti - roactemra, f'taħlita ma ' methotrexate (mtx), huwa indikat għall-kura ta attiva u progressiva severa, artrite rewmatojde (ra) fl-adulti li ma kienux ittrattati qabel b'mtx. il-kura moderata għal severa u attiva f'pazjenti adulti li jkollhom jew wieġbu b'mod inadegwat għal, jew li kienu intolleranti għal, it-terapija preċedenti b'wieħed jew aktar li jimmodifikaw il-marda anti-rewmatiċi-mediċini (dmards) jew tal-fattur ta'nekrożi tumorali (tnf) antagonisti. f'dawn il-pazjenti, roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa. roactemra ġie muri li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika meta jingħata flimkien ma ' methotrexate. roactemra huwa indikat għall-kura ta attiva sistemika, artrite idjopatika ġuvenili (sjia) fil-pazjenti li 1-età ta'sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma ' nsaids u kortikosterojdi sistemiċi. roactemra jista 'jingħata bħala monoterapija (fil-każ ta' intolleranza għal mtx jew fejn kura b'mtx mhux xierqa) jew flimkien ma ' mtx. roactemra flimkien ma 'methotrexate (mtx), huwa indikat għall-kura ta idjopatika ġuvenili polijartrite (pjia; rewmatika fattur pożittiv jew negattiv u estiż oligoarthritis) f'pazjenti 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma' mtx. roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa. roactemra huwa indikat għall-kura tal-Ġgant taċ-Ċelluli artrite (gca) f'pazjenti adulti. roactemra, f'taħlita ma ' methotrexate (mtx), huwa indikat għall -: - trattament ta attiva u progressiva severa, artrite rewmatojde (ra) fl-adulti li ma kienux ittrattati qabel b'mtx. il-kura moderata għal severa u attiva f'pazjenti adulti li jkollhom jew wieġbu b'mod inadegwat għal, jew li kienu intolleranti għal, it-terapija preċedenti b'wieħed jew aktar li jimmodifikaw il-marda anti-rewmatiċi-mediċini (dmards) jew tal-fattur ta'nekrożi tumorali (tnf) antagonisti. f'dawn il-pazjenti, roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa.  roactemra has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. roactemra is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. roactemra huwa indikat għall-kura ta attiva sistemika, artrite idjopatika ġuvenili (sjia) f'pazjenti 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma ' nsaids u kortikosterojdi sistemiċi. roactemra jista 'jingħata bħala monoterapija (fil-każ ta' intolleranza għal mtx jew fejn kura b'mtx mhux xierqa) jew flimkien ma ' mtx. roactemra flimkien ma 'methotrexate (mtx), huwa indikat għall-kura ta idjopatika ġuvenili polijartrite (pjia; rewmatika fattur pożittiv jew negattiv u estiż oligoarthritis) f'pazjenti 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma' mtx. roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa. roactemra huwa indikat għall-kura ta kimeriku tal-antiġen tar-riċettur (karozza) taċ-ċelluli t-indotta severi jew li jipperikolaw il-ħajja-reħa taċ-ċitokina sindromu (crs) fl-adulti u pazjenti pedjatriċi minn 2 snin ta ' età u anzjani. roactemra, f'taħlita ma ' methotrexate (mtx), huwa indikat għall -: - trattament ta attiva u progressiva severa, artrite rewmatojde (ra) fl-adulti li ma kienux ittrattati qabel b'mtx. il-kura moderata għal severa u attiva f'pazjenti adulti li jkollhom jew wieġbu b'mod inadegwat għal, jew li kienu intolleranti għal, it-terapija preċedenti b'wieħed jew aktar li jimmodifikaw il-marda anti-rewmatiċi-mediċini (dmards) jew tal-fattur ta'nekrożi tumorali (tnf) antagonisti. f'dawn il-pazjenti, roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa.  roactemra has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. roactemra is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. roactemra huwa indikat għall-kura ta attiva sistemika, artrite idjopatika ġuvenili (sjia) f'pazjenti 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma ' nsaids u kortikosterojdi sistemiċi. roactemra jista 'jingħata bħala monoterapija (fil-każ ta' intolleranza għal mtx jew fejn kura b'mtx mhux xierqa) jew flimkien ma ' mtx. roactemra flimkien ma 'methotrexate (mtx), huwa indikat għall-kura ta idjopatika ġuvenili polijartrite (pjia; rewmatika fattur pożittiv jew negattiv u estiż oligoarthritis) f'pazjenti 2-il sena u akbar, li ma kellhomx rispons xieraq għat-terapija preċedenti ma' mtx. roactemra jista 'jingħata bħala monoterapija f'kaz ta' intolleranza għal mtx jew fejn kura kontinwa b'mtx mhux xierqa. roactemra huwa indikat għall-kura ta kimeriku tal-antiġen tar-riċettur (karozza) taċ-ċelluli t-indotta severi jew li jipperikolaw il-ħajja-reħa taċ-ċitokina sindromu (crs) fl-adulti u pazjenti pedjatriċi minn 2 snin ta ' età u anzjani.

Uni Eropa - Malta - EMA (European Medicines Agency)

novartis europharm limited - dabrafenib mesilate - melanoma - aġenti antineoplastiċi - melanomadabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 u 5. kura awżiljarja tal-melanomadabrafenib flimkien ma trametinib huwa indikat għall-kura awżiljarja ta ' pazjenti adulti b'fażi iii melanoma bil-braf v600, wara li jitlesta r-risezzjoni. non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.