União Europeia - maltês - EMA (European Medicines Agency)

novartis europharm limited - omalizumab - asthma; urticaria - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - allerġiċi asthmaxolair huwa indikat fl-adulti, l-adoloxxenti u t-tfal (6 sa.

União Europeia - maltês - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - aġenti antineoplastiċi oħra - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

União Europeia - maltês - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - immunosoppressanti - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

União Europeia - maltês - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - l-isklerożi multipla, sklerożi multipla li tirkadi u tbatti - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.

União Europeia - maltês - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - belatacept - graft rejection; kidney transplantation - immunosoppressanti - nulojix, in combination with corticosteroids and a mycophenolic acid (mpa), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant.

União Europeia - maltês - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - epatite b, antiġen tal-wiċċ rikombinanti - hepatitis b; immunization - vaċċini - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. l-speċifiċi fil-kategoriji tar-riskju biex jiġu immunizzati għandhom jiġu determinati fuq il-bażi tar-rakkomandazzjonijiet uffiċjali. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma tfeġġx fl-assenza ta ' l-epatite b infezzjoni. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. l-speċifiċi fil-kategoriji tar-riskju biex jiġu immunizzati għandhom jiġu determinati fuq il-bażi tar-rakkomandazzjonijiet uffiċjali. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma tfeġġx fl-assenza ta ' l-epatite b infezzjoni. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. huwa mistenni li epatite d tiġi evitata wkoll permezz tat-tilqima b'hbvaxpro billi l-epatite d (ikkawżata mill-aġent delta) ma sseħħx fin-nuqqas ta ' infezzjoni tal-epatite b.

União Europeia - maltês - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - immunosoppressanti - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

União Europeia - maltês - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - aġenti antineoplastiċi - rituzena huwa indikat fl-adulti għall-indikazzjonijiet li ġejjin:mhux ta 'hodgkin (nhl)rituzena huwa indikat għall-kura ta' pazjenti mhux trattati qabel ma l-istadju iii-iv limfoma follikulari flimkien mal-kimoterapija. rituzena monoterapija hija indikata għat-trattament ta 'pazjenti b'stadju iii-iv limfoma follikulari li huma kemo reżistenti jew li qegħdin fit-tieni jew aktar episodju ta' rkadar wara kimoterapija. rituzena huwa indikat għall-kura ta 'pazjenti bil-tixrid pożittiv cd20 taċ-ċelluli b kbar mhux ta' hodgkin il-limfoma f'kombinazzjoni ma ' chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) l-kimoterapija. lewkimja limfoċitika kronika (cll)rituzena flimkien ma 'kimoterapija huwa indikat għat-trattament ta' pazjenti li ma kienux trattati qabel u li reġgħet tfaċċat/refrattarja cll. hemm biss informazzjoni limitata disponibbli fuq l-effikaċja u s-sigurtà għall-pazjenti li qabel kienu kkurati b'antikorpi monoklonali inkluż rituzenaor pazjenti refrattarji għal preċedenti rituzena flimkien ma ' kimoterapija. granulomatosi b'polianġite u mikroskopika polyangiitisrituzena, flimkien ma 'glukokortikosterojdi, huwa indikat għall-induzzjoni ta' remissjoni f'pazjenti adulti b'mard sever, attiv granulomatosi b'polianġite (wegener) (fap) u polianġite mikroskopika (mpa).

União Europeia - maltês - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastoma - aġenti antineoplastiċi - unituxin huwa indikat għat-trattament ta ' riskju għoli neuroblastoma fil-pazjenti l-età ta ' 12-il xahar li 17years, li kienu riċevuti induzzjoni chemotherapy qabel u miksub mill-inqas tweġiba parzjali, segwita minn terapija myeloablative u ċelluli staminali awtologi trapjant (asct). jingħata flimkien ma 'fattur li jistimula l-kolonja tal-granuloċit-makrofagi (gm-csf), interleukin-2 (il-2), u isotretinoin.

União Europeia - maltês - EMA (European Medicines Agency)

resilience biomanufacturing ireland limited - influwenza avjana (kollu virion, mhux attivati) li jkun fih anti $ enu ta: a/vjetnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaċċini - profilassi tal-influwenza f'sitwazzjoni pandemika ddikjarata uffiċjalment. il-vaċċin kontra l-influwenza pandemika għandu jintuża skond il-gwida uffiċjali.