Unjoni Ewropea - Malti - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosoppressanti - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 u 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

allergan pharmaceuticals international ltd - trab tal-frixa - insuffiċjenza pankreatika exocrine - diġestivi, inkl. enżimi - trattament ta 'sostituzzjoni ta' enzimi pankreatiċi f'insuffiċjenza pankreatika exocrine minħabba fibrożi ċistika jew kundizzjonijiet oħra (e. pankreatite kronika, pankreatectomija ta 'wara jew kanċer tal-frixa). enzepi huwa indikat fit-trabi, tfal, l-adoloxxenti u l-adulti.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

dechra regulatory b.v. - mirtazapine - psychoanaleptics, antidepressants in combination with psycholeptics - qtates - għall-piż tal-ġisem jiksbu fil-qtates jesperjenzaw foqra fl-aptit u l-piż tal-telf li jirriżulta minn mard kroniku tal-kundizzjonijiet mediċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

rhythm pharmaceuticals netherlands b.v. - setmelanotide - obeżità - preparazzjonijiet ta 'kontra l-ossessjoni, esklużi prodotti tad-dieta - imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed bardet biedl syndrome (bbs), loss-of-function biallelic pro-opiomelanocortin (pomc), including pcsk1, deficiency or biallelic leptin receptor (lepr) deficiency in adults and children 6 years of age and above.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

lipomed gmbh - thalidomide - majloma multipla - immunosoppressanti - thalidomide lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy. thalidomide lipomed is prescribed and dispensed in accordance with the thalidomide lipomed pregnancy prevention programme (see section 4.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amryt ag - betulae cortex - wounds and injuries; wound healing - preparazzjonijiet għat-trattament ta 'feriti u ulċeri - trattament ta 'feriti ta' ħxuna parzjali fl-adulti. ara t-taqsimiet 4. 4 u 5. 1 fl-informazzjoni dwar il-prodott fir-rigward tat-tip ta 'feriti studjati.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

smithkline beecham ltd - rosiglitazone, glimepiride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - avaglim hu indikat biss fit-trattament tad-dijabete tat-tip 2 mellitus il-pazjenti li ma jistgħux jiksbu kontroll gliċemiku biżżejjed bl-aħjar dożaġġ ta ' monoterapija b'sulphonylurea, u li għalihom metformin mhux adattat minħabba kontra-indikazzjoni jew intolleranza.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

medac - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - inibituri tal-proteina kinase - imatinib medac huwa indikat għall-kura ta': 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 ta' trattament;pazjenti pedjatriċi b'ph+cml fil-fażi kronika wara l-falliment ta ' l-interferon-alpha-terapija, jew fil-fażi aċċelerata;pazjenti adulti u pedjatriċi b'ph+cml fi 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;il-pazjenti adulti li ma jistax jitneħħa dermatofibrosarcoma protuberans (dfsp) u pazjenti adulti bil-rikorrenti u/jew metastatiku dfsp li mhumiex eliġibbli għall-kirurġija. l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. f'pazjenti adulti u pedjatriċi, l-effikaċja ta 'imatinib hija bbażata fuq globali ematoloġiċi u ċitoġenetiċi-rati ta' rispons u sopravivenza mingħajr progressjoni f'cml, fuq ematoloġiċi u ċitoġenetiċi-rati ta 'rispons f'ph+all, mds/mpd, fuq il-rati ta' rispons ematoloġiku f'hes/cel u dwar l-objettiv tal-rati ta ' rispons fil-pazjenti adulti li ma jistax jitneħħa u/jew metastiku dfsp. l-esperjenza b'imatinib f'pazjenti b'mds/mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna. 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)

novartis europharm limited - lapatinib - neoplażmi tas-sider - inibituri tal-proteina kinase - tyverb huwa indikat għall-kura ta 'pazjenti b'kanċer tas-sider, liema tumuri jesprimu bil-qawwa her2 (erbb2):flimkien ma' capecitabine għall-pazjenti b'marda avvanzata jew metastatika mal-progressjoni wara terapija ta 'qabel, li għandha tinkludi anthracyclines u taxanes u terapija bi trastuzumab fi l-kanċer metastatiku tal-twaqqif;flimkien ma' trastuzumab għall-pazjenti bl-ormon tat-riċettur negattivi għall-mard metastatiku li mexa fuq minn qabel ta 'trastuzumab it-terapija jew it-terapiji flimkien ma' kimoterapija;f'kumbinazzjoni ma ' inibitur aromatase għall-nisa wara l-menopawsa bl-ormon tat-riċettur pożittivi għall-mard metastatiku, li bħalissa mhux maħsub għall-kimoterapija. il-pazjenti fil-reġistrazzjoni-istudju ma kinux ġew ittrattati preċedentement ma ' trastuzumab jew inibitur aromatase. l-ebda dejta disponibbli dwar l-effikaċja ta 'din it-taħlita relattiva għal trastuzumab f'kumbinazzjoni ma' inibitur aromatase f'din il-popolazzjoni ta ' pazjenti.