Europeiska unionen - danska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiske midler - vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with: intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification. vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.

Europeiska unionen - danska - 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 - antineoplastiske midler - 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.

Europeiska unionen - danska - 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 - antineoplastiske midler - 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.

Danmark - danska - Lægemiddelstyrelsen (Danish Medicines Agency)

therakos europe ltd, - methoxsalen - opløsning til modificering af blodfraktioner - 20 mikrogram/ml

Europeiska unionen - danska - EMA (European Medicines Agency)

mendelikabs europe ltd - nitisinon - tyrosinemias - andre alimentary tract and metabolism produkter, - behandling af voksne og pædiatriske patienter (i alle aldersgrupper) med bekræftet diagnose af arvelig tyrosinæmi type 1 (ht 1) i kombination med diætbegrænsning af tyrosin og phenylalanin.

Europeiska unionen - danska - EMA (European Medicines Agency)

cycle pharmaceuticals (europe) ltd - nitisinon - tyrosinemias - andre alimentary tract and metabolism produkter, - behandling af voksne og pædiatriske patienter med den bekræftede diagnose af arvelige tyrosinemia type 1 (ht-1) i kombination med kosten begrænsning af tyrosin og fenylalanin.

Europeiska unionen - danska - EMA (European Medicines Agency)

pharmsure veterinary products europe ltd - mycoplasma synoviae stamme ms-h - immunologicals for aves, live bakterielle vacciner - kylling - til aktiv immunisering af fremtidige slagtekyllinger, kyllinger fra fremtidige lagdeltagere og fremtidige lagkyllinger for at reducere lungerne og reducere antallet af æg med unormal skaldannelse forårsaget af mycoplasma synoviae.

Europeiska unionen - danska - EMA (European Medicines Agency)

retrophin europe ltd - cholsyre - metabolisme, infødte fejl - galde og lever terapi - cholic syre fgk er indiceret til behandling af medfødte fejl af primær galdesyre syntese, i spædbørn fra én måneds alder til kontinuerlig livslang behandling gennem voksenalderen, omfatter følgende enkelt enzym fejl:sterol-27-hydroxylase (fremlægger som cerebrotendinous xanthomatosis, ctx) mangel;2- (eller alpha-) methylacyl-coa racemase (amacr) mangel;kolesterol 7 alfa-hydroxylase (cyp7a1) - mangel.

Europeiska unionen - danska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - thalidomid - multipelt myelom - immunosuppressiva - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

Europeiska unionen - danska - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd. - chlormethine - mycosis fungoides - antineoplastiske midler - ledaga er indiceret til topisk behandling af mycosis fungoides-type kutant t-celle lymfom (mf-type ctcl) hos voksne patienter.