Euroopan unioni - suomi - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ozanimod hydrochloride - multiple sclerosis, relapsing-remitting; colitis, ulcerative - immunosuppressantit - multiple sclerosiszeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features. ulcerative colitiszeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

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)

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)

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)

bristol myers squibb pharma eeig - luspatercept - anemia; myelodysplastic syndromes; beta-thalassemia - muut anemialääkkeet - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5. reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia (see section 5.

Euroopan unioni - suomi - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - antineoplastiset aineet - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Euroopan unioni - suomi - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - pomalidomide - multiple myeloma - immunosuppressantit - imnovid yhdessä bortetsomibin ja deksametasonin on tarkoitettu aikuisille potilaille, joilla on multippeli myelooma, jotka ovat saaneet vähintään yhtä aiempaa hoitoa hoito, mukaan lukien lenalidomidi. imnovid yhdessä dexamethasone on mainittu hoidon aikuispotilailla, joilla on uusiutunut ja tulenkestävät multippeli myelooma jotka ovat saaneet vähintään kaksi ennen hoito, kuten lenalidomidia ja bortetsomibin, ja ovat osoittaneet taudin etenemistä viime hoidon.

Euroopan unioni - suomi - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - lenalidomidi - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - immunosuppressantit - useita myelomarevlimid monoterapiana on tarkoitettu huolto aikuisille potilaille, joilla on äskettäin diagnosoitu useita myelooma, joille on tehty autologinen kantasolusiirto. revlimid-valmistetta kuin yhdistelmähoito deksametasonin kanssa, tai bortetsomibin ja deksametasonin tai melfalaanin ja prednisonin kanssa (ks. kohta 4. 2) on tarkoitettu aikuisille potilaille, joilla on aiemmin hoitamaton multippeli myelooma, jotka eivät ole oikeutettuja siirto. revlimid deksametasoniin yhdistettynä on tarkoitettu hoitoon multippelia myeloomaa sairastaville aikuispotilaille, jotka ovat saaneet vähintään yhtä aiempaa hoitoa. myelodysplastinen syndromesrevlimid monoterapiana on tarkoitettu aikuisille potilaille, joilla on verensiirto-riippuvainen anemia johtuu matalan tai keskitason-1-riskin myelodysplastisia oireyhtymiä liittyvät eristetty poistetaan 5q sytogeneettinen poikkeavuus, kun muut hoitovaihtoehdot ovat riittämättömiä tai. mantle cell lymphomarevlimid monoterapiana on tarkoitettu aikuispotilaille, joilla on uusiutunut tai vaikeahoitoinen manttelisolulymfooman. follikulaarinen lymphomarevlimid yhdessä rituksimabin (anti-cd20-vasta-aine) on tarkoitettu aikuisille potilaille, joilla on aiemmin käsitelty follikulaarinen lymfooma (grade 1 – 3a).

Euroopan unioni - suomi - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - efavirentsi - hiv-infektiot - antiviraalit systeemiseen käyttöön - sustiva on osoitettu ihmisen immuunikatoviruksen 1 (hiv-1) infektoituneiden aikuisten, nuorten ja kolmen vuoden ikäisten ja vanhempien lasten antiviraalisen yhdistelmähoidossa. sustivaa ei ole tutkittu riittävästi potilailla, joilla on pitkälle edennyt hiv-tauti eli potilailla, joiden cd4-arvo on < 50 solua/mm3, tai kun vika proteaasi-inhibiittori (pi)-sisältävät hoito-ohjelmat. vaikka ristiresistenssiä efavirentsin ja proteaasinestäjien kesken ei ole dokumentoitu, tällä hetkellä ei ole riittävästi tietoa tehoa myöhempää käyttöä pi-pohjainen yhdistelmä hoidon jälkeen epäonnistuminen hoito sisältää sustiva.

Euroopan unioni - suomi - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumabi - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastiset aineet - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 ja 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.