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

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna er indisert for behandling av voksne og paediatric pasienter med synstap på grunn av arvelig retinal dystrofi forårsaket av bekreftet biallelic rpe65 mutasjoner, og som har tilstrekkelig levedyktige celler retinal.

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

bluebird bio (netherlands) b.v. - autologous cd34+ celle beriket befolkningen som inneholder blodkreft stamceller transduced med lentiglobin bb305 lentiviral vektor koding av beta-en-t87q-globin-genet - beta-thalassemia - other hematological agents - zynteglo er indisert for behandling av pasienter som er 12 år og eldre med transfusjon-avhengige β thalassaemia (tdt) som ikke har en β0/β0 genotype, for hvem haematopoietic stilk cellen (hsc) transplantasjon er riktig, men en human leukocyte antigen (hla)-matchet i slekt hsc donor er ikke tilgjengelig.

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

alfasigma s.p.a. - metyltioniniumklorid - colorectal neoplasms; colonoscopy - other diagnostic agents - lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

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

biocryst ireland limited - berotralstat dihydrochloride - angioødemer, arvelig - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

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

accord healthcare s.l.u. - icatibant acetate - angioødemer, arvelig - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.

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

orion corporation - tasipimidine sulfate - other hypnotics and sedatives - hunder - alleviation of situational anxiety and fear in dogs triggered by e. travel, noise, owner departure, veterinary visits.

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

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

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

agios netherlands b.v. - mitapivat sulfate - genetic diseases, inborn; anemia, hemolytic - other hematological agents - pyrukynd is indicated for the treatment of pyruvate kinase deficiency (pk deficiency) in adult patients (see section 4.

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

csl behring gmbh - etranacogene dezaparvovec - hemofili b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

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

accord healthcare s.l.u. - degarelix acetate - prostata neoplasmer - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.