Unjoni Ewropea - Malti - EMA (European Medicines Agency)

linde healthcare ab - nitric oxide - hypertension, pulmonary; respiratory insufficiency - prodotti oħra tas-sistema respiratorja - inomax, flimkien mal-'ventilazzjoni-appoġġ u l-oħra xierqa sustanzi attivi, huwa indikat għall-kura ta 'trabi tat-twelid ≥34-il-ġimgħa ġestazzjoni b'indeboliment respiratorju ipoksiku assoċjat ma' jew ekokardjografiku evidenza ta 'pressjoni għolja pulmonari, sabiex ittejjeb l-ammont ta' ossiġenu u tnaqqas il-ħtieġa għal ossiġenazzjoni ta 'membrana ekstrakorporali;bħala parti mill-kura ta' waqt u wara l-operazzjoni pressjoni pulmonari għolja fl-adulti u trabi tat-twelid, trabi u tfal żgħar, tfal u l-adoloxxenti, l-etajiet 0-17-il sena, flimkien mal-kirurġija tal-qalb, sabiex selettiv tnaqqis ta ' pressjoni arterjali pulmonari u jtejbu l-ventrikolu tal-lemin tal-funzjoni u l-ossiġenazzjoni.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - vismodegib - karċinoma, Ċellula basal - aġenti antineoplastiċi - erivedge huwa indikat għall-kura ta ' pazjenti adulti bil -: - sintomatika metastatiku tal-karċinoma taċ-ċellola bażali - lokalment avvanzat karċinoma taċ-ċellola bażali inadegwata għall-kirurġija jew radjoterapija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

xbiotech germany gmbh - antikorp monoklonali uman igg1 speċifiku għal interleukin-1 alfa tal-bniedem - neoplażmi kolorettali - aġenti antineoplastiċi - it-trattament tal-kanċer metastatiku tal-kolorektum.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

acino pharma gmbh  - clopidogrel - mard vaskulari periferali - aġenti antitrombotiċi - clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta 'avvenimenti aterotrombotiċi f': pazjenti li jbatu minn infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard arterjali periferali. - pazjenti li jbatu mis-sindromu koronarju akut: mhux elevazzjoni tas-segment st sindromu koronarju akut (anġina instabbli jew mhux tal-mewġa q 'infart mijokardijaku), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutanju, flimkien ma' acetylsalicylic acid (asa). l - elevazzjoni tas-segment st infart mijokardijaku akut, flimkien ma ' asa f'medikament pazjenti kkurati b'eliġibbli għat-terapija trombolitika. għall-aktar informazzjoni jekk jogħġbok irreferi għal sezzjoni 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - nintedanib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - vargatef hija indikata fil kombinazzjoni ma jeanne għat-trattament tal-pazjenti adulti b ' kanċer tal-pulmun avvanzat lokalment, metastatic jew rikorrenti lokalment taċ-ċellola mhux-żgħira (nsclc) ta ' adenocarcinoma tumur istoloġija wara l-ewwel linja chemotherapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

eisai gmbh - lenvatinib mesilate - karċinoma, Ċellula renali - aġenti antineoplastiċi - kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (rcc):in combination with pembrolizumab, as first-line treatment (see section 5. in combination with everolimus, following one prior vascular endothelial growth factor (vegf)-targeted therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - aġenti antineoplastiċi - imatinib koanaa is indicated for the treatment ofadult 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. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

biofrontera bioscience gmbh - idroklorur ta 'l-aċidu 5-aminolevuliniku - keratosis, actinic; carcinoma, basal cell - aġenti antineoplastiċi - it-trattament ta'keratosi aktinika ta ' severita ħafifa għal moderata fuq il-wiċċ u l-qorriegħa (olsen grad 1-2; ara t-taqsima 5. 1) u tal-qasam cancerization fl-adulti. it-trattament tal-superfiċjali u/jew nodular karċinoma taċ-ċellola bażali mhux tajbin għall-kura kirurġika minħabba possibbli relatati mal-kura-morbidità u/jew foqra kosmetiċi-eżitu fl-adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - immunosoppressanti - jekk jogħġbok irreferi għad-dokument ta 'informazzjoni dwar il-prodott.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

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.