Evropska unija - slovenščina - 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, mantle cell - 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).

Evropska unija - slovenščina - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirusi za sistemsko uporabo - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 in 5. tecovirimat siga should be used in accordance with official recommendations.

Evropska unija - slovenščina - EMA (European Medicines Agency)

biomarin international limited - valoctocogene roxaparvovec - antihemoragije - treatment of severe haemophilia a (congenital factor viii deficiency) in adult patients without a history of factor viii inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (aav5).

Evropska unija - slovenščina - EMA (European Medicines Agency)

pierre fabre medicament - tabelecleucel - lymphoproliferative disorders - ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory epstein-barr virus positive post-transplant lymphoproliferative disease (ebv+ ptld) who have received at least one prior therapy. for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Evropska unija - slovenščina - EMA (European Medicines Agency)

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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

n.v. organon - colecalciferol, alendronic acid (as sodium trihydrate) - osteoporoza, postmenopavz - zdravila za zdravljenje bolezni kosti - zdravljenje postmenopavzne osteoporoze pri bolnikih s tveganjem za pomanjkanje vitamina d. adrovance zmanjšuje tveganje vretenc in zlomov kolka.

Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxo group ltd. - amprenavir - okužbe z virusom hiv - antivirusi za sistemsko uporabo - zdravilo agenerase, v kombinaciji z drugimi protiretrovirusnimi zdravili, je indicirano za zdravljenje zaviralcev proteaze (pi), ki so se doživeli odrasli in otroci, okuženi s hiv-1, in njihovi otroci, starejši od 4 let. kapsule agenerase je običajno treba dajati z majhnim odmerkom ritonavirja kot farmakokinetičnega povečevalnika amprenavirja (glejte poglavja 4. 2 in 4. izbira amprenavirja mora temeljiti na testiranju odpornosti na posamezne virusne odmerke in zgodovini zdravljenja bolnikov (glejte poglavje 5). koristi agenerase razširila z ritonavir ni bila dokazana v pi ladjo bolnikih (glejte poglavje 5.

Evropska unija - slovenščina - EMA (European Medicines Agency)

sanofi b.v. - laronidaza - mucopolisaharidoza i - drugi zdravljene bolezni prebavil in presnove izdelki, - aldurazyme je označen za dolgoročno encim nadomestno zdravljenje pri bolnikih s potrjeno diagnozo mucopolysaccharidosis i (mps i; alfa-l-iduronidase pomanjkljivost) za zdravljenje nonneurological manifestacije bolezni.

Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxo group ltd. - flutikazon furoat - rhinitis, allergic, perennial; rhinitis, allergic, seasonal - nosni pripravki - odrasli, mladostniki (12 let in več) in otroci (od 6 do 11 let). zdravilo alisade je indicirano za zdravljenje simptomov alergijskega rinitisa.