Uni Eropa - Malta - 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.

Uni Eropa - Malta - EMA (European Medicines Agency)

sanofi b.v. - olipudase alfa - acid sphingomyelinase deficiency (asmd) type a/b or type b - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-central nervous system (cns) manifestations of acid sphingomyelinase deficiency (asmd) in paediatric and adult patients with type a/b or type b.

Uni Eropa - Malta - EMA (European Medicines Agency)

yes pharmaceutical development services gmbh - doxorubicin hydrochloride - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - aġenti antineoplastiċi - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Uni Eropa - Malta - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - atogepant - disturbi fl-emigranja - aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Uni Eropa - Malta - EMA (European Medicines Agency)

alfasigma s.p.a. - piperaquine tetraphosphate, artenimol - malarja - antiprotozoali - eurartesim huwa indikat għall-kura ta 'malarja plasmodium falciparum mhux ikkumplikata f'adulti, tfal u trabi ta' 6 xhur jew aktar u li jiżnu 5 kg jew aktar. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu adattat ta ' aġenti antimalarial.

Uni Eropa - Malta - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - newtropenja - immunostimulanti, - grastofil huwa indikat għall-tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti trattati ma chemotherapy ċitotossiċi stabbiliti għall-malignancy (bl-eċċezzjoni tal-lewċemja myeloid kronika u myelodysplastic sindromi) u għat-tnaqqis fit-tul tal-neutropenia fil-pazjenti sottoposti għal terapija myeloablative segwit mill-mudullun trapjant meqjusa li huma f'riskju akbar ta ' neutropenia ħorox imtawla. is-sigurtà u l-effikaċja ta grastofil huma simili fl-adulti u t-tfal li qed jirċievu kimoterapija ċitotossika. grastofil huwa indikat għall-mobilizzazzjoni ta ' ċelluli proġenituri tad-demm (pbpcs). f'pazjenti, tfal jew adulti b'severa konġenitali, ċiklika, jew newtropenja idjopatika bl-għadd assolut ta 'newtrofili (anc) ta' ≤ 0. 5 x 109/l, u storja ta severi jew infezzjonijiet rikorrenti fit-tul fit-amministrazzjoni tal-grastofil huwa indikat biex jiżdied l-għadd ta'newtrofili u biex inaqqas l-inċidenza u t-tul ta ' l-infezzjoni avvenimenti relatati mal-. grastofil huwa indikat għall-kura ta 'newtropenja persistenti (anc ta' inqas minn jew ugwali għal 1. 0 x 109 / l) f'pazjenti b'infezzjoni avvanzata ta 'l-hiv, sabiex jitnaqqas ir-riskju ta' infezzjonijiet batteriċi meta għażliet oħra biex tiġi amministrata n-newtropenija mhumiex xierqa.

Uni Eropa - Malta - EMA (European Medicines Agency)

teva b.v. - lipegfilgrastim - newtropenja - immunostimulanti, , l-fatturi li jistimulaw kolonji - lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Uni Eropa - Malta - EMA (European Medicines Agency)

takeda pharma a/s - ferumoxytol - anemia; kidney failure, chronic - oħra antianemic preparazzjonijiet - rienso huwa indikat għall-kura ġol-vina ta 'anemija ta' defiċjenza tal-ħadid f'pazjenti adulti b'mard kroniku tal-kliewi (ckd). id-dijanjożi ta 'defiċjenza ta' ħadid għandha tkun ibbażata fuq testijiet tal-laboratorju xierqa (ara sezzjoni 4.

Uni Eropa - Malta - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - ropeginterferon alfa-2b - polycythemia vera - immunostimulanti, - besremi huwa indikat bħala monoterapija fl-adulti għat-trattament ta ' poliċitemija vera mingħajr sintomatika splenomegalija.

Uni Eropa - Malta - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedemas, ereditarji - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.