Unjoni Ewropea - Malti - 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.

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)

janssen-cilag international nv - etravirine - infezzjonijiet ta 'hiv - non-nucleoside reverse transcriptase inhibitors, antivirals for systemic use - intelence, f ' għaqda mal-qawwa protease inibitur u oħra antiretroviral il-prodotti mediċinali, huwa indikat għat-trattament ta ' l-infezzjoni umani-immunodefiċjenza-virus-tip-1 (hiv-1) fil-pazjenti adulti antiretroviral-trattament-esperjenzati u fl-antiretroviral-trattament-esperjenzati paediatric pazjenti minn sitt snin ta ' età. din l-indikazzjoni hija bbażata fuq il-ġimgħa 48 minn żewġ analiżi tal-fażi iii tal-provi ħafna pazjenti ttrattati minn qabel fejn intelence kien investigat flimkien ma ' reġimen fl-isfond ottimizzat (obr) li kien jinkludi darunavir/ritonavir. l-indikazzjoni f'pazjenti pedjatriċi hija bbażata fuq 48 ġimgħa, l-analiżi ta'single-arm tal-fażi ii prova antiretrovirali li esperjenzaw it-trattament-pazjenti pedjatriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - guanfacine hydrochloride - tnaqqis tad-defiċit ta 'l-attenzjoni b'hérapectivity - antiadrenergic agents, centrally acting, antihypertensives, - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. intuniv għandhom ikunu użati bħala parti minn komprensiva adhd-programm tat-trattament, tipikament inkluż psikoloġiċi, l-edukazzjoni u l-miżuri soċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - gefitinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - iressa huwa indikat għall-kura ta 'pazjenti adulti b'lokalment avvanzat jew dak metastatiku li mhux żgħar tal-pulmun taċ-ċelluli tal-kanċer b'mutazzjonijiet li jattivaw tal-epidermali-tkabbir tal-fattur-riċetturi ta' tyrosine kinase.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

theravia - dexamethasone - majloma multipla - kortikosterojdi għal użu sistemiku - trattament ta 'majeloma multipla.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, kobikistat, emtricitabine, tenofovir disoproxil fumarate - infezzjonijiet ta 'hiv - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - trattament tal-virus ta ' immunodefiċjenza umani 1 (hiv 1) infezzjoni fl-adulti età 18 snin jew aktar li huma naïve tat-trattament tal-antiretroviral jew li huma infettati bl-hiv 1 mingħajr mutazzjonijiet magħrufa assoċjati ma ' reżistenza għal kwalunkwe tat-tliet aġenti antiretroviral fl stribild.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, kobikistat - infezzjonijiet ta 'hiv - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta, huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' infezzjoni tal-virus tal-immunodefiċjenza umana 1 (hiv 1) f'adulti ta '18-il sena jew akbar. Ġenotipika l-ittestjar għandu jiggwida l-użu tal-rezolsta.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig - crizotinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - aġenti antineoplastiċi - xalkori as monotherapy is indicated for:the first‑line treatment of adults with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with previously treated anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc)the treatment of adults with ros1‑positive advanced non‑small cell lung cancer (nsclc)the treatment of paediatric patients (age ≥6 to.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - lewkimja, linfokitika, kronika, b-Ċellula - aġenti antineoplastiċi - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.