Polivy Unjoni Ewropea - Malti - EMA (European Medicines Agency)

polivy

roche registration gmbh - polatuzumab vedotin - limfoma, b-cell - aġenti antineoplastiċi - polivy flimkien ma bendamustine u rituximab huwa indikat għall-kura ta ' pazjenti adulti b'reġgħet tfaċċat/refrattarja b kbira mxerrda-cell lymphoma (dlbcl) li mhumiex kandidati għall-trapjant ta'ċelloli staminali ematopojetiċi. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Gazyvaro Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gazyvaro

roche registration gmbh - obinutuzumab - lewkimja, linfokitika, kronika, b-Ċellula - aġenti antineoplastiċi - lewkimja limfoċitika kronika (cll)gazyvaro flimkien ma 'chlorambucil huwa indikat għall-kura ta' pazjenti adulti li ma kienux ikkurati qabel lewkimja limfoċitika kronika (cll) u ma 'ko-morbożità li tagħmilhom tajbin għall-full-doża ta' fludarabine bbażata fuq it-terapija (ara sezzjoni 5. limfoma follikulari (fl)gazyvaro flimkien mal-kimoterapija, segwit minn gazyvaro terapija ta 'manteniment fil-pazjenti li laħqu rispons, huwa indikat għall-kura ta' pazjenti li ma kienux ikkurati qabel avvanzati limfoma follikulari. gazyvaro flimkien ma bendamustine segwit minn gazyvaro-manutenzjoni huwa indikat għall-kura ta ' pazjenti b'limfoma follikulari (fl) li ma jkunux irrispondew jew li żviluppaw waqt jew sa 6 xhur wara kura b'rituximab jew rituximab-reġimen li fih.

Arzerra Unjoni Ewropea - Malti - EMA (European Medicines Agency)

arzerra

novartis europharm ltd - ofatumumab - lewkimja, linfokitika, kronika, b-Ċellula - antikorpi monoklonali - ma kienux trattati qabel lewkimja limfoċitika kronika (cll): arzerra flimkien ma 'chlorambucil jew bendamustine huwa indikat għall-kura ta' pazjenti b'cll li ma rċevew terapija minn qabel u li mhumiex eliġibbli għall-fludarabine-terapija bbażata fuq. rkadew cll: arzerra huwa indikat flimkien ma 'fludarabine u cyclophosphamide għat-trattament ta' pazjenti adulti b'all rikadut cll. refrattarji cll: arzerra huwa indikat għall-kura ta cll f'pazjenti li huma refrattarji għal pazjenti b'b-ll u alemtuzumab.

Imbruvica Unjoni Ewropea - Malti - EMA (European Medicines Agency)

imbruvica

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Varuby Unjoni Ewropea - Malti - EMA (European Medicines Agency)

varuby

tesaro bio netherlands b.v. - rolapitant - vomiting; nausea; cancer - anti-emetiċi u anti-nawżjanti, - prevenzjoni ta 'dardir u rimettar ittardjat assoċjati ma' kimoterapija tal-kanċer emetoġenika ħafna u moderat fl-adulti. varuby jingħata bħala parti minn terapija ta'kombinazzjoni.

Kymriah Unjoni Ewropea - Malti - EMA (European Medicines Agency)

kymriah

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.

Rituzena (previously Tuxella) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

rituzena (previously tuxella)

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).

Brukinsa Unjoni Ewropea - Malti - EMA (European Medicines Agency)

brukinsa

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - aġenti antineoplastiċi - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Venclyxto Unjoni Ewropea - Malti - EMA (European Medicines Agency)

venclyxto

abbvie deutschland gmbh co. kg - venetoclax - lewkimja, linfokitika, kronika, b-Ċellula - aġenti antineoplastiċi - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Calquence Unjoni Ewropea - Malti - EMA (European Medicines Agency)

calquence

astrazeneca ab - acalabrutinib - lewkimja, linfokitika, kronika, b-Ċellula - antineoplastic agents, protein kinase inhibitors, - calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll). calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.