Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - drugi antineoplastični agensi - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - idecabtagene vicleucel - multiple myeloma; neoplasms; cancer; neoplasms, plasma cell; hemostatic disorders; vascular diseases; cardiovascular diseases; paraproteinemias; blood protein disorders; hematologic diseases; hemic and lymphatic diseases; hemorrhagic disorders; infectious mononucleosis; lymphoproliferative disorders; immunoproliferative disorders; immune system diseases - antineoplastična sredstva - abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three 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)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - limfom, mantel-stanica - antineoplastična sredstva - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - antineoplastična sredstva - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - multipli mijelom - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three 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)

tmc pharma (eu) limited - fosdenopterin hydrobromide dihydrate - metal metabolism, inborn errors - drugi gastrointestinalni trakt i metabolizam, lijekovi, - nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (mocd) type a.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - ostali lijekovi protiv živčanog sustava - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Europska Unija - hrvatski - EMA (European Medicines Agency)

pharma mar s.a. - trabectedin - ovarian neoplasms; sarcoma - antineoplastična sredstva - yondelis je indiciran za liječenje bolesnika s naprednim sarkom mekog tkiva, nakon neuspjeha anatraciklinima, i ili nezgodan za primanje tih agenata su. podaci o učinkovitosti temelje se uglavnom na bolesnika s liposarkom i leiomyosarcomom. Йонделис u kombinaciji s пегилированным липосомальным doksorubicin (fpga) indiciran za liječenje pacijenata s relaps платино osjetljivi raka jajnika .

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

teva b.v., swensweg 5, haarlem, nizozemska - trabektedin - prašak za koncentrat za otopinu za infuziju - urbroj: jedna bočica praška sadrži 0,25 mg trabektedina jedan ml rekonstituirane otopine sadrži 0,05 mg trabektedina

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

teva b.v., swensweg 5, haarlem, nizozemska - trabektedin - prašak za koncentrat za otopinu za infuziju - urbroj: jedna bočica praška sadrži 1 mg trabektedina jedan ml rekonstituirane otopine sadrži 0,05 mg trabektedina