Braftovi European Union - Slovenian - EMA (European Medicines Agency)

braftovi

pierre fabre medicament - encorafenib - melanoma; colorectal neoplasms - antineoplastična sredstva - encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (crc) with a braf v600e mutation, who have received prior systemic therapy.

Zydelig European Union - Slovenian - EMA (European Medicines Agency)

zydelig

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Venclyxto European Union - Slovenian - 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.

Lenalidomide Accord European Union - Slovenian - EMA (European Medicines Agency)

lenalidomide accord

accord healthcare s.l.u. - lenalidomid - multiple myeloma - imunosupresivi - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki niso primerni za presaditev. lenalidomide sebe v kombinaciji z dexamethasone je primerna za zdravljenje več plazmocitom pri odraslih bolnikih, ki so prejeli vsaj en pred terapijo. follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Polivy European Union - Slovenian - 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).

Lenalidomide Mylan European Union - Slovenian - EMA (European Medicines Agency)

lenalidomide mylan

mylan ireland limited - lenalidomid - multiple myeloma - imunosupresivi - multiple myelomalenalidomide mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. lenalidomide mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide mylan in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1-3a).

Lenalidomide Krka d.d. European Union - Slovenian - EMA (European Medicines Agency)

lenalidomide krka d.d.

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - imunosupresivi - multiple myelomalenalidomide krka d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) je indiciran za zdravljenje odraslih bolnikov s predhodno nezdravljenih več plazmocitom, ki niso primerni za presaditev. lenalidomide krka d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. follicular lymphomalenalidomide krka d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Tavneos European Union - Slovenian - EMA (European Medicines Agency)

tavneos

vifor fresenius medical care renal pharma france - avacopan - microscopic polyangiitis; wegener granulomatosis - imunosupresivi - tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa).