Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim - empagliflozin, metformin - diabetes mellitus, tip 2 - drogi użati fid-dijabete - synjardy huwa indikat f'adulti ta '18-il sena u akbar b'dijabete mellitus tip 2 bħala żieda mad-dieta u l-eżerċizzju biex itejjeb il-kontroll gliċemiku f'pazjenti mhux ikkontrollati adegwatament fuq l-ogħla doża ttollerata ta' metformin waħdu;f'pazjenti li mhumiex ikkontrollati biżżejjed bil-metformina flimkien ma'l-oħra tal-glukożju il-prodotti mediċinali li jbaxxu, inkluża l-insulina;fil-pazjenti li diġà qegħdin jiġu kkurati b'kumbinazzjoni ta empagliflozin u metformin bħala pilloli separati.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19f - pneumococcal infections; immunization - vaċċini - immunizzazzjoni attiva kontra mard invażiv u otite medja akuta kkawżata minn streptococcus pneumoniae fi trabi u tfal minn sitt ġimgħat sa ħames snin. ara t-taqsimiet 4. 4 u 5. 1 fl-informazzjoni dwar il-prodott għal informazzjoni dwar il-protezzjoni kontra serotipi pnewmokokkali speċifiċi. l-użu ta synflorix għandu jiġi determinat fuq il-bażi ta 'rakkomandazzjonijiet uffiċjali filwaqt li jitqiesu l-impatt ta' mard invażiv fi gruppi differenti ta ' età, kif ukoll il-varjabilità tal-epidemjoloġija tas-serotip f'żoni ġeografiċi differenti.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer limited  - metaflumizone - ektoparasitaċidali għall-użu topiku, inklużi. insettiċidi - qtates - trattament u prevenzjoni ta 'infestazzjonijiet tal-briegħed (ctenocephalides canis u c. felis) fil-qtates. il-prodott mediċinali veterinarju jista 'jintuża bħala parti minn strateġija ta' trattament għal dermatite tal-allerġija tal-briegħed (fad).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - immunosoppressanti - multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 u 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 u 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - immunosoppressanti - multiple myelomalenalidomide krka d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. lenalidomide krka d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. follicular lymphomalenalidomide krka d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - lenalidomide - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - immunosoppressanti - multipli myelomarevlimid bħala monoterapija huwa indikat għall-manteniment tat-trattament ta ' pazjenti adulti li jkunu għadhom kif ġew dijanjostikati mjeloma multipla li jkunu għaddew minn awtologi t-trapjant taċ-ċelluli staminali. revlimid bħala terapija kombinata ma ' dexamethasone, jew bortezomib u dexamethasone, jew melphalan u prednisone (ara sezzjoni 4. 2) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. revlimid flimkien ma 'dexamethasone hu indikat għall-kura ta' majeloma multipla f'pazjenti adulti li jkunu rċevew mill-anqas terapija waħda qabel. majelodisplastiċi syndromesrevlimid bħala monoterapija hija indikata għat-trattament ta 'pazjenti adulti b'trasfużjoni dipendenti fuq l-anemija minħabba baxx intermedju jew 1-riskju sindromi majelodisplastiċi assoċjata ma' iżolati tal-tħassir 5q ċitoġenetiku anormalità meta għażliet terapewtiċi oħrajn ma jkunux biżżejjed jew inadegwata. f'forma ta'tubu taċ-ċelluli lymphomarevlimid bħala monoterapija hija indikata għat-trattament ta ' pazjenti adulti b'all rikadut jew refrattarju f'forma ta'tubu taċ-ċelluli tal-limfoma. follikulari lymphomarevlimid flimkien ma 'rituximab (kontra l-antiġen cd20 ta' antikorpi) huwa indikat għat-trattament ta ' pazjenti adulti li kienu kkurati qabel limfoma follikulari (grad 1 – 3a).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - luspatercept - anemia; myelodysplastic syndromes; beta-thalassemia - oħra antianemic preparazzjonijiet - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5. reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia (see section 5.

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)

boehringer ingelheim international gmbh - pramipexole dihydrochloride monohydrate - restless legs syndrome; parkinson disease - mediċini kontra l-parkinson - mirapexin huwa indikat għat-trattament tas-sinjali u sintomi tal-marda ta 'parkinson idjopatika, waħedha (mingħajr levodopa) jew flimkien ma' levodopa, i. matul il-kors tal-marda, sa stadji tardivi meta l-effett ta 'levodopa jilbes jew isir inkonsistenti u jseħħu ċaqliq fl-effett terapewtiku (varjazzjonijiet fit-tmiem tad-doża jew' on-off '). mirapexin hu indikat għall-kura sintomatika ta moderata għal severa idjopatika kwiet-sindrome tas-saqajn, f'dożaġġi sa 0. 54 mg ta ' bażi (0. 75 mg ta ' melħ).