Gazyvaro Evropska unija - slovenščina - EMA (European Medicines Agency)

gazyvaro

roche registration gmbh - obinutuzumab - levkemija, limfocitna, kronična, b-celica - antineoplastična sredstva - kronično limfocitno levkemijo (cll)gazyvaro v kombinaciji z chlorambucil je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih kronično limfocitno levkemijo (cll) in z comorbidities česar so neprimerni za celoten odmerek fludarabine temelji terapije (glejte poglavje 5. folikularni limfom (fl)gazyvaro v kombinaciji s kemoterapijo, sledi gazyvaro vzdrževanje terapije pri pacientih, ki so dosegli odziv, ki je primerna za zdravljenje bolnikov s predhodno nezdravljenih napredno folikularni limfom. gazyvaro v kombinaciji z bendamustine sledi gazyvaro vzdrževanje je indiciran za zdravljenje bolnikov z folikularni limfom (fl), ki niso odzvali ali kdo napredoval med ali do 6 mesecev po zdravljenju z rituksimabom ali rituksimabom, ki vsebujejo režim.

Calquence Evropska unija - slovenščina - EMA (European Medicines Agency)

calquence

astrazeneca ab - acalabrutinib - levkemija, limfocitna, kronična, b-celica - 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 Evropska unija - slovenščina - EMA (European Medicines Agency)

columvi

roche registration gmbh  - glofitamab - lymphoma, large b-cell, diffuse - antineoplastična sredstva - 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 Evropska unija - slovenščina - EMA (European Medicines Agency)

brukinsa

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastična sredstva - 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 Evropska unija - slovenščina - EMA (European Medicines Agency)

venclyxto

abbvie deutschland gmbh co. kg - venetoclax - levkemija, limfocitna, kronična, b-celica - antineoplastična sredstva - 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.

Imbruvica Evropska unija - slovenščina - 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 Evropska unija - slovenščina - EMA (European Medicines Agency)

polivy

roche registration gmbh - polatuzumab vedotin - limfom, b-celice - antineoplastična sredstva - polivy v kombinaciji z bendamustine in rituksimabom je indiciran za zdravljenje odraslih bolnikov z relapsed/ognjevzdržni razpršenih veliko b-celični limfom (dlbcl), ki niso kandidati za haematopoietic matičnih celic za presajanje. 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).

Benmak 2,5 mg/ml prašek za koncentrat za raztopino za infundiranje Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

benmak 2,5 mg/ml prašek za koncentrat za raztopino za infundiranje

makpharm d.o.o. - bendamustinijev klorid - prašek za koncentrat za raztopino za infundiranje - bendamustinijev klorid 2,5 mg / 1 ml - bendamustin

Benmak 2,5 mg/ml prašek za koncentrat za raztopino za infundiranje Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

benmak 2,5 mg/ml prašek za koncentrat za raztopino za infundiranje

makpharm d.o.o. - bendamustinijev klorid - prašek za koncentrat za raztopino za infundiranje - bendamustinijev klorid 2,5 mg / 1 ml - bendamustin

Levact 2,5 mg/ml prašek za koncentrat za raztopino za infundiranje Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

levact 2,5 mg/ml prašek za koncentrat za raztopino za infundiranje

astellas pharma gmbh - bendamustinijev klorid - prašek za koncentrat za raztopino za infundiranje - bendamustinijev klorid 2,5 mg / 1 ml - bendamustin