Union européenne - maltais - EMA (European Medicines Agency)

pfizer europe ma eeig - respiratory syncytial virus, subgroup a, stabilized prefusion f protein / respiratory syncytial virus, subgroup b, stabilized prefusion f protein - infezzjonijiet ta 'virus sintetiku respiratorju - vaċċini - abrysvo is indicated for:passive protection against lower respiratory tract disease caused by respiratory syncytial virus (rsv) in infants from birth through 6 months of age following maternal immunisation during pregnancy. ara t-taqsimiet 4. 2 u 5. active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by rsv. l-użu ta ' dan il-vaċċin għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Union européenne - maltais - EMA (European Medicines Agency)

teva b.v. - reslizumab - ażma - mediċini sistemiċi oħrajn għall-imblokkar tal-passaġġ tan-nifs mard, - cinqaero huwa indikat bħala terapija iż-żieda fil-pazjenti adulti bl-asthma eosinophilic severi mhux ikkontrollat minkejja doża għolja ġewwa man-nifs corticosteroids biż- żieda ta ' prodott mediċinali ieħor għat-trattament ta ' manutenzjoni.

Union européenne - maltais - EMA (European Medicines Agency)

teva pharma b.v. - clopidogrel, acetylsalicylic acid - acute coronary syndrome; myocardial infarction - kombinazzjonijiet - clopidogrel / acetylsalicylic acid teva huwa indikat għall-prevenzjoni ta 'avvenimenti aterotrombotiċi f'pazjenti adulti li diġà qegħdin jieħdu clopidogrel u acetylsalicylic acid (asa). clopidogrel/acetylsalicylic acid teva huwa kombinazzjoni b'doża fissa tal-prodott mediċinali għall-kontinwazzjoni tat-terapija:mhux elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux‑mewġa‑q infart mijokardijaku) li jinkludu pazjenti fi proċess li titpoġġa stent wara koronarju perkutanju interventionst elevazzjoni tas-segment infart mijokardijaku akut fil-medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika.

Union européenne - maltais - EMA (European Medicines Agency)

ge healthcare b.v. - ioflupane (123l) - tomography, emission-computed, single-photon; lewy body disease; parkinson disease; alzheimer disease - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali huwa għal użu dijanjostiku biss. datscan huwa indikat għall-osservazzjoni telf tal-funzjonali tan-newroni dopaminerġiċi terminali fl-istriatum:f'pazjenti adulti b'klinikament inċerti u sindromi ta'parkinson, per eżempju dawk b'sintomi bikrija, biex jgħin jagħraf bejn tregħid essenzjali u sindromi ta'parkinson relatati mal-marda idjopatika ta ' parkinson, atrofija multipla tas-sistema u progressive supranuclear palsy. datscan huwa f'pożizzjoni li jiddistingwi bejn il-marda ta'parkinson, atrofija multipla tas-sistema u progressive supranuclear palsy. f'pazjenti adulti, li jgħin biex jiddistingwi-probabbiltà ta ' dimenzja b'lewy bodies mill-marda ta'alzheimer. datscan ma jistgħux jiddiskriminaw bejn dimenzja mal-korpi lewy u l-marda ta ' parkinson id-dimenzja.

Union européenne - maltais - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - tacrolimus - rifjut ta 'graft - immunosoppressanti - profilassi tar-rifjut tat-trapjanti f'riċevituri ta 'l-alloġib tal-kliewi jew tal-fwied adulti. kura ta 'rifjut tal-allograft reżistenti għat-trattament ma' prodotti mediċinali immunosoppressivi oħra f'pazjenti adulti.

Union européenne - maltais - EMA (European Medicines Agency)

novartis europharm limited - deferasirox - beta-thalassemia; iron overload - il-prodotti terapewtiċi l-oħra kollha - exjade huwa indikat għall-kura ta ' tagħbija żejda minħabba frekwenti trasfużjonijiet tad-demm fuq il-ħadid kronika (≥ 7 ml/kg/xahar taċ-ċelloli tad-demm ħomor ippakkjati) fil-pazjenti b ' beta thalassaemia maġġuri età ta ' sitt snin u aktar antiki. exjade huwa indikat ukoll għat-trattament tal-eċċess kroniku ta'ħadid minħabba trasfużjonijiet tad-demm meta terapija b'deferoxamine tkun kontra-indikata jew inadegwata f'dawn gruppi ta 'pazjenti:pazjenti b'beta-talessimja maġġuri b'tagħbija żejda tal-ħadid minħabba trasfużjonijiet tad-demm frekwenti (≥ 7 ml/kg/xahar ta' ċelloli ħomor ippakkjati) bejn is-sentejn u l-ħames snin;f'pazjenti b'beta-talessimja maġġuri b'tagħbija żejda tal-ħadid minħabba trasfużjonijiet mhux frekwenti (< 7 ml/kg/xahar ta 'ċelloli ħomor ippakkjati) f'etajiet ta' sentejn u akbar fl-età;f'pazjenti li jkollhom anemiji oħrajn li għandhom sentejn u aktar. exjade huwa indikat ukoll għat-trattament tal-eċċess kroniku ta'ħadid li tirrikjedi terapija ta ' kelazzjoni b'meta terapija b'deferoxamine tkun kontra-indikata jew inadegwata f'pazjenti li mhux dipendenti mit-trasfużjoni talassemija sindromi bejn l-10 snin u l-anzjani.

Union européenne - maltais - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. Ħlief fil għadhom kif ġew dijanjostikati cml ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard. .

Union européenne - maltais - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. , l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. l-esperjenza b'imatinib f'pazjenti b'mds/mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna. m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

Union européenne - maltais - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva huwa indikat għall-kura ofadult u f'pazjenti pedjatriċi li jkunu għadhom kif ġew dijanjostikati-kromosoma ta ' filadelfja (bcr‑abl) positive (ph+) lewkimja kronika tal-majelojd (cml) li għalihom trapjant tal-mudullun ma jkunx meqjus bħala l-ewwel linja tal-kura. pazjenti adulti u pedjatriċi b'ph+ cml fil-fażi kronika wara l-falliment ta ' l-interferon‑alpha-terapija, jew fil-fażi aċċelerata jew blast crisis. pazjenti adulti u pedjatriċi li jkunu għadhom kif ġew dijanjostikati philadelphia chromosome positive li għandhom lewkimja limfoblastika akuta (ph+ all) integrata b'kimoterapija. pazjenti adulti b'all rikadut jew refrattarju ph+ all bħala monoterapija. pazjenti adulti b'mard majelodisplastiku/majeloproliferattiv (mds/mpd) assoċjat ma ' plejtlits-riċettur tal-fattur tat-tkabbir derivat (pdgfr) ġeni mill-ġdid l-arranġamenti. pazjenti adulti b'avvanzati sindrome ipereżinofiliku (hes) u/jew lewkimja kronika eosinofilika (cel) b'fip1l1-pdgfra arranġament mill-ġdid. l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. imatinib teva is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pazjenti li għandhom livell baxx jew l-riskju baxx ħafna ta ' rikorrenza m'għandhomx jirċievu kura awżiljarja. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. Ħlief fil għadhom kif ġew dijanjostikati cml ta ' fażi kronika, m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

Union européenne - maltais - EMA (European Medicines Agency)

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.