Euroopan unioni - suomi - EMA (European Medicines Agency)

molmed spa - allogeenisten t-solujen geneettisesti muunnettuja antiretroviraalisten vektori koodaus katkaistu jonkinlainen ihmisen vähäinen affiniteetti hermo kasvutekijän reseptorin (Δlngfr) ja herpes simplex virus tymidiinikinaasi (hsv-tk mut2) - hematopoietic stem cell transplantation; graft vs host disease - antineoplastiset aineet - zalmoxis on ilmoitettu lisähoitona haploidentical hematopoeettisten kantasolujen siirroista (potilaat) aikuisten potilaiden korkean riskin hematologisia pahanlaatuisia.

Euroopan unioni - suomi - 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 - antineoplastiset aineet - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

akcea therapeutics ireland limited - volanesorsen natrium - hyperlipoproteinemia tyyppi i - muut lipid modifying agents - waylivra on tarkoitettu ruokavalion lisänä aikuisilla potilailla, joilla oli geneettisesti varmistettu familiaalinen chylomicronemia oireyhtymä (fcs) ja korkea riski saada haimatulehdus, johon vastaus ruokavalio ja triglyseridejä alentava hoito on ollut riittämätöntä.

Euroopan unioni - suomi - 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 - antineoplastiset aineet - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

olympus biotech international limited - eptotermiini alfa - spondylolisthesis - lääkkeet luusairauksien hoitoon - opgenra on tarkoitettu posterolateralisen lannerangan fuusioon aikuispotilailla, joilla on spondylolisthesis, jos autograft on epäonnistunut tai on vasta-aiheinen.

Euroopan unioni - suomi - EMA (European Medicines Agency)

olympus biotech international limited - eptotermiini alfa - tibiaaliset murtumat - lääkkeitä luuston sairauksien hoidossa, luun morfogeneettisiä proteiineja - kuulumaton tibia vähintään 9 kuukauden ajan, toissijainen trauma, skeletally kypsä potilailla tapauksissa kun aiempi hoito autograft on epäonnistunut tai autograft käyttöä on mahdotonta.

Euroopan unioni - suomi - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - muut antineoplastiset aineet - 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.

Euroopan unioni - suomi - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - atsakitidiini - leukemia, myeloidi, akuutti - antineoplastiset aineet - onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (aml) who achieved complete remission (cr) or complete remission with incomplete blood count recovery (cri) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (hsct).

Euroopan unioni - suomi - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - autologisen cd34+ - solujen rikastettu väestöstä, joka sisältää hematopoieettisten kantasolujen transduced kanssa lentiglobin bb305 lentiviral vector koodaus beta-a-t87q-globiinigeenin - beeta-talassemia - other hematological agents - zynteglo on tarkoitettu niiden potilaiden hoitoon 12-vuotiaille ja sitä vanhemmille, transfusion-dependent β-talassemia (tdt), jotka eivät ole β0/β0 genotyyppi, joille hematopoieettisten kantasolujen (hsc) elinsiirrot on aiheellista, mutta ihmisten niiden erittelylaskenta antigeenin (hla)-sovitettu liittyvät hsc luovuttaja ei ole saatavilla.

Euroopan unioni - suomi - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - muut hermoston huumeet - 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.