Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - aġenti antineoplastiċi - glivec 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-pdgfra rearrangement. , l-effett ta 'glivec fuq l-eżitu ta' l-għadam-trapjant tal-mudullun għadu ma ġiex determinat. glivec is indicated for: , 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. pazjenti li għandhom livell baxx jew l-riskju baxx ħafna ta ' rikorrenza m'għandhomx jirċievu kura awżiljarja;, il-kura ta'pazjenti adulti li ma jistax jitneħħa dermatofibrosarcoma protuberans (dfsp) u pazjenti adulti bil-rikorrenti u / jew metastatiku dfsp li mhumiex eliġibbli għall-kirurġija. , f'pazjenti adulti u pedjatriċi, l-effikaċja ta 'glivec 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-gist u dfsp u dwar ir-rikorrenza-sopravivenza mingħajr progressjoni fl-adjuvant gist. l-esperjenza bi glivec f'pazjenti b'mds / mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna (ara taqsima 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.

Umoja wa Ulaya - Kimalta - 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.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (mahoney strain), type 2 (mef-1 strain), type 3 (saukett strain)), hepatitis b surface antigen - hepatitis b; tetanus; immunization; whooping cough; poliomyelitis; diphtheria - vaċċini - infanrix penta huwa indikat għall-vaċċinazzjoni primarja u booster tat-trabi kontra diphtheria, tetanus, pertussis, epatite b u poliomyelitis.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

pharmsure veterinary products europe ltd - strain mycoplasma synoviae ms-h - immunoloġiċi għall-aves, jgħixu vaċċini batterjali - chicken - għall-immunizzazzjoni attiva tal-futur tal-brojlers irabbi-tiġieġ, fil-futur saff irabbi-tiġieġ u l-futur saff-tiġieġ sabiex jitnaqqsu l-arja sac-leżjonijiet u jnaqqsu l-għadd tal-bajd bil-qoxra mhux normali formazzjoni kkawżati minn mycoplasma synoviae.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

warner chilcott uk ltd. - testosterone - disfunzjonijiet sesswali, psikoloġiċi - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - intrinsa huwa indikat għall-kura ta ' l-hypoactive sesswali xewqa diżordni (hsdd) fin-nisa (menopause mezz kirurġikament indotti) bilateralment oophorectomised u hysterectomised li tirċievi estrogen konkomittenti terapija.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - palifermin - mukosite - il-prodotti terapewtiċi l-oħra kollha - kepivance huwa indikat li tnaqqas l-inċidenza, it-tul u s-severità tal-mucositis orali fil-pazjenti adulti ma malignancies ħematoloġiċi li jirċievu radiochemotherapy ta ' myeloablative assoċjati ma ' l-inċidenza għolja ta ' mucositis ħorox u li jeħtieġu haematopoietic-zokk-ċelloli awtoloġiċi appoġġ.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

warner chilcott  deutschland gmbh - testosterone - disfunzjonijiet sesswali, psikoloġiċi - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - livensa huwa indikat għall-kura ta ' l-hypoactive sesswali xewqa diżordni (hsdd) fin-nisa (menopause mezz kirurġikament indotti) bilateralment oophorectomised u hysterectomised li tirċievi estrogen konkomittenti terapija.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

novartis europharm limited - sacubitril, valsartan - insuffiċjenza tal-qalb - aġenti li jaġixxu fuq is-sistema renin-angiotensin - paediatric heart failureneparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5. adult heart failureneparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

dompé biotec s.p.a. - darbepoetin alfa - kidney failure, chronic; anemia; cancer - preparazzjonijiet antianemiċi - kura ta 'anemija sintomatika assoċjata ma' insuffiċjenza renali kronika (crf) f'adulti u pazjenti pedjatriċi. kura ta ' anemija sintomatika f'pazjenti adulti bil-kanċer tumuri malinni mhux majelojdi li qed jirċievu l-kimoterapija.

Umoja wa Ulaya - Kimalta - EMA (European Medicines Agency)

sloan pharma s.a.r.l - tossina botulinum tat-tip b - torticollis - rilassanti tal-muskoli - neurobloc huwa indikat għall-kura ta 'distonja ċervikali (torticollis). ara t-taqsima 5. 1 għall-informazzjoni dwar l-effikaċja f'pazjenti li jirrispondu / jirreżistu għal botulinum toxin tip a.