Den Europæiske Union - dansk - 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) - lymfom, mantelcelle - antineoplastiske midler - 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).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

recordati rare diseases - betain vandfri - homocystinuri - andre alimentary tract and metabolism produkter, - adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (cbs);5,10-methylene-tetrahydrofolate reductase (mthfr);cobalamin cofactor metabolism (cbl). cystadane should be used as supplement to other therapies such as vitamin b6 (pyridoxine), vitamin b12 (cobalamin), folate and a specific diet.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propandiolmonohydrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - narkotika anvendt i diabetes - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. i tillæg til andre lægemidler til behandling af type 2-diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propandiolmonohydrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - narkotika anvendt i diabetes - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. i tillæg til andre lægemidler til behandling af type 2-diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin - diabetes mellitus, type 2 - narkotika anvendt i diabetes - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (som phosphat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastiske midler - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. polycythaemia vera (pv)jakavi er indiceret til behandling af voksne patienter med polycythaemia vera, som er resistente over for eller intolerante over for hydroxyurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

astrazeneca ab - moxetumomab pasudotox - leukæmi, hårete celler - antineoplastiske midler - lumoxiti as monotherapy is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukaemia (hcl) after receiving at least two prior systemic therapies, including treatment with a purine nucleoside analogue (pna).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - cytomegalovirusinfektioner - antivirale midler til systemisk anvendelse - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). det bør overvejes at officielle vejledning om hensigtsmæssig brug af antivirale agenter.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - narkotika anvendt i diabetes - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

nordic group b.v. - tegafur, gimeracil, oteracil - mave neoplasmer - antineoplastiske midler - teysuno is indicated in adults:- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5. - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.