Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi b.v. - laronidase - mucopolysaccharidosis i - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - aldurazyme hu indikat għal enżimi fuq żmien twil terapija tas-sostituzzjoni f'pazjenti b'dijanjosi kkonfermata ta ' mucopolysaccharidosis i (mps i; alfa-l-iduronidase defiċjenza) biex jikkura l-nonneurological manifestazzjonijiet tal-marda.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - sklerosi multipla - immunosuppressanti selettivi - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi pasteur s.a. - virus tal-influwenza (inattivat, maqsuma) tar-razez li ġejjin:/california/7/2009 (h1n1)pdm09 - like strain (a/california/7/2009, nymc x-179a)a/hong kong/4801/2014 (h3n2) like strain (a/hong kong/4801/2014, nymc x-263b)b/brisbane/60/2008 - like strain (b/brisbane/60/2008, tat-tip selvaġġ) - influenza, human; immunization - vaċċini - profilassi ta 'l-influwenza f'individwi ta' 60 sena jew aktar, speċjalment f'dawk li għandhom riskju akbar ta 'kumplikazzjonijiet assoċjati. l-użu ta ' idflu għandu jkun ibbażat fuq rakkomandazzjonijiet uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi pasteur europe - virus tal-influwenza (inattivat, maqsuma) tar-razez li ġejjin:/california/7/2009 (h1n1)pdm09 - like strain (a/california/7/2009, nymc x-179a)a/hong kong/4801/2014 (h3n2) like strain (a/hong kong/4801/2014, nymc x-263b)b/brisbane/60/2008 - like strain (b/brisbane/60/2008, tat-tip selvaġġ) - influenza, human; immunization - vaċċini - profilassi ta 'l-influwenza f'individwi ta' 60 sena jew aktar, speċjalment f'dawk li għandhom riskju akbar ta 'kumplikazzjonijiet assoċjati. l-użu ta ' intanza għandu jkun ibbażat fuq rakkomandazzjonijiet uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi b.v. - alglucosidase alfa - mard tal-Ħażna tal-glukoġen tat-tip ii - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - myozyme huwa indikat għal terapija s-sostituzzjoni ta ' l-enżima fit-tul (ert) fil-pazjenti bl-djanjosi konfermata tal-marda ta ' l-pompe (aċidu-α-glucosidase defiċjenza). f'pazjenti b'bidu tard tal-marda marda ta ' pompe l-evidenza tal-effikaċja hija limitata.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis; microscopic polyangiitis; pemphigus - aġenti antineoplastiċi - rixathon is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rixathon is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. rixathon maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. rixathon monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. rixathon is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. rixathon in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). lewkimja limfoċitika kronika (cll)rixathon flimkien ma 'kimoterapija huwa indikat għat-trattament ta' pazjenti li ma kienux trattati qabel u li reġgħet tfaċċat/refrattarja ta ' lewkimja limfoċitika kronika. hemm biss informazzjoni limitata disponibbli fuq l-effikaċja u s-sigurtà għall-pazjenti li qabel kienu kkurati b'antikorpi monoklonali inkluż rituximab jew pazjenti refrattarji għal preċedenti rituximab flimkien ma ' kimoterapija. ara t-taqsima 5. 1 għal aktar informazzjoni. rewmatika arthritisrixathon flimkien ma 'methotrexate huwa indikat għall-kura ta' pazjenti adulti b' ' l-artrite rewmatika attiva severa li kellhom rispons inadegwat jew intolleranza għal oħra li timmodifika l-marda anti-rewmatiċi-mediċini (dmard) fosthom wieħed jew aktar tal-fattur tan-nekrożi tat-tumur (tnf) inibitur terapiji. rituximab wera li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. granulomatosis with polyangiitis and microscopic polyangiitisrixathon, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). rixathon, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisrixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - aġenti antineoplastiċi - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. hemm biss informazzjoni limitata disponibbli fuq l-effikaċja u s-sigurtà għall-pazjenti li qabel kienu kkurati b'antikorpi monoklonali inkluż rituximab jew pazjenti refrattarji għal preċedenti rituximab flimkien ma ' kimoterapija. ara t-taqsima 5. 1 għal aktar informazzjoni. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rituximab wera li jnaqqas ir-rata ta 'progressjoni tal-ħsara fil-ġogi kif imkejjel permezz ta' x-ray, u li jtejjeb il-funzjoni fiżika, meta jingħata flimkien ma ' methotrexate. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sandoz gmbh - pegfilgrastim - newtropenja - immunostimulanti, - tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti adulti ttrattati ċitotossiċi chemotherapy għall-malignancy (bl-eċċezzjoni ta ' kronika myeloid lewċemja u myelodysplastic sindromi).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi b.v. - avalglucosidase alfa - mard tal-Ħażna tal-glukoġen tat-tip ii - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with pompe disease (acid α-glucosidase deficiency).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sandoz gmbh - trastuzumab - breast neoplasms; stomach neoplasms - aġenti antineoplastiċi - treatment of metastatic and early breast cancer and metastatic gastric cancer (mgc).