Europska Unija - hrvatski - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - daunorubicin hydrochloride, cytarabine - leukemija, mieloidna, akutna - antineoplastična sredstva - vyxeos liposomal indiciran za liječenje odraslih bolesnika s je prvi put dijagnosticiran, terapije povezane s oštrim миелоидными лейкозами (t-aml) ili aml s миелодисплазией promjene (aml-МРЦ).

Europska Unija - hrvatski - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - antineoplastična sredstva - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Europska Unija - hrvatski - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - prekursorska stanica limfoblastične leukemije-limfom - antineoplastična sredstva - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astrazeneca ab - olaparib - neoplazme jajnika - antineoplastična sredstva - jajnika cancerlynparza prikazan kao monoterapija za:podržava liječenje odraslih bolesnika s поздними (figo faze iii i iv) u genima brca1/2-mutirani (зародышевой linije i/ili somatskih) brzorezni epitela jajnika, masterbatch cijevi ili primarni перитонеальный rak, koji u odgovor (potpuno ili djelomično) nakon završetka prve linije na bazi platine kemoterapije. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 i 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacijenti moraju prethodno bile tretirane s антрациклина i таксана u (neo)adjuvantne ili метастатический, ako pacijenti nisu prikladni za tih postupaka (vidi odjeljak 5. pacijenti s receptore hormona (h)-pozitivnog raka dojke treba također razvili ili nakon pre-hormonska terapija, ili se smatraju neprikladnim za endokrine terapije. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

takeda pharma a/s - ixazomib citrat - multipli mijelom - antineoplastična sredstva - ninlaro u kombinaciji s lenalidomidom i deksametazonom je indiciran za liječenje odraslih bolesnika s multiplim mijelom koji su primili najmanje jednu prethodnu terapiju.

Europska Unija - hrvatski - EMA (European Medicines Agency)

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).

Europska Unija - hrvatski - EMA (European Medicines Agency)

roche registration gmbh - mosunetuzumab - limfom, folikularni - antineoplastic agents, monoclonal antibodies - lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) who have received at least two prior systemic therapies.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - multipli mijelom - antineoplastična sredstva - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - epcoritamab - lymphoma, large b-cell, diffuse - antineoplastična sredstva - tepkinly 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - prekursorska stanica limfoblastične leukemije-limfom - antineoplastična sredstva - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.