Gazyvaro Európska únia - slovenčina - EMA (European Medicines Agency)

gazyvaro

roche registration gmbh - obinutuzumab - leukémia, lymfocytárna, chronická, b-bunka - antineoplastické činidlá - chronic lymphocytic leukémia (cll)gazyvaro v kombinácii s chlorambucil je indikovaný na liečbu dospelých pacientov s predtým neliečených chronic lymphocytic leukémia (cll) a s comorbidities čo je nevhodné pre celú dávku fludarabine založené liečby (pozri časť 5. follicular lymfóm (fl)gazyvaro v kombinácii s chemoterapiou, nasleduje gazyvaro udržiavaciu liečbu u pacientov dosiahnutie odpoveď, je indikovaný na liečbu pacientov s predtým neliečených rozšírené follicular lymfóm. gazyvaro v kombinácii s bendamustine nasleduje gazyvaro údržba je indikovaný na liečbu pacientov s follicular lymfóm (fl), ktorý nereagoval, alebo ktorý postupoval v priebehu, alebo až 6 mesiacov po ukončení liečby s rituximabom alebo rituximab-obsahujúce režim.

Venclyxto Európska únia - slovenčina - EMA (European Medicines Agency)

venclyxto

abbvie deutschland gmbh co. kg - venetoclax - leukémia, lymfocytárna, chronická, b-bunka - antineoplastické činidlá - 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 Európska únia - slovenčina - EMA (European Medicines Agency)

calquence

astrazeneca ab - acalabrutinib - leukémia, lymfocytárna, chronická, b-bunka - 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.

Columvi Európska únia - slovenčina - EMA (European Medicines Agency)

columvi

roche registration gmbh  - glofitamab - lymphoma, large b-cell, diffuse - antineoplastické činidlá - columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl), after two or more lines of systemic therapy.

Brukinsa Európska únia - slovenčina - EMA (European Medicines Agency)

brukinsa

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastické činidlá - 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).

Imbruvica Európska únia - slovenčina - 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.

Polivy Európska únia - slovenčina - EMA (European Medicines Agency)

polivy

roche registration gmbh - polatuzumab vedotin - lymfóm b-buniek - antineoplastické činidlá - polivy v kombinácii s bendamustine a rituximab je indikovaný na liečbu dospelých pacientov s relapsed/žiaruvzdorné plošných veľké b-buniek lymfóm (dlbcl), ktorí nie sú kandidátmi na hematopoetickú transplantácii kmeňových buniek. 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).

Bendamustine Kabi 2,5 mg/ml Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

bendamustine kabi 2,5 mg/ml

fresenius kabi s.r.o., Česká republika - bendamustín - 44 - cytostatica

Bendamustine Glenmark 2,5 mg/ml Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

bendamustine glenmark 2,5 mg/ml

glenmark pharmaceuticals s.r.o., Česká republika - bendamustín - 44 - cytostatica