Den europeiske union - norsk - EMA (European Medicines Agency)

pari pharma gmbh - tobramycin - respiratory tract infections; cystic fibrosis - antibakterielle midler for systemisk bruk, - vantobra er indisert for behandling av kronisk lunge infeksjon på grunn av pseudomonas aeruginosa hos pasienter i alderen 6 år og voksne med cystisk fibrose (cf). det bør vurderes å offisielle retningslinjer for riktig bruk av antibakterielle midler.

Den europeiske union - norsk - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - andre nervesystemet narkotika - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Den europeiske union - norsk - EMA (European Medicines Agency)

dipharma arzneimittel gmbh - sapropterin dihydrochloride - phenylketonurias - andre alimentary tract and metabolism products, - sapropterin dipharma is indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with phenylketonuria (pku) who have been shown to be responsive to such treatment. sapropterin dipharma is also indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with tetrahydrobiopterin (bh4) deficiency who have been shown to be responsive to such treatment.

Den europeiske union - norsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cystisk fibrose - andre åndedrettsprodukter - orkambi tabletter er angitt for behandling av cystisk fibrose (cf) hos pasienter i alderen 6 år og eldre som er homozygote for f508del-mutasjon i cftr-genet. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Den europeiske union - norsk - EMA (European Medicines Agency)

co.don gmbh - sfæroider av humane autologe matrisassosierte kondrocytter - brusk sykdommer - andre legemidler for forstyrrelser i muskel-skjelettsystemet - reparasjon av symptomatiske leddbruskdefekter i lårkondylen og knottens patella (international cartilage repair society [icrs] klasse iii eller iv) med defektstørrelser på opptil 10 cm2 hos voksne.

Den europeiske union - norsk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cystisk fibrose - andre åndedrettsprodukter - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Den europeiske union - norsk - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - andre nervesystemet narkotika - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Den europeiske union - norsk - EMA (European Medicines Agency)

tmc pharma (eu) limited - fosdenopterin hydrobromide dihydrate - metal metabolism, inborn errors - andre alimentary tract and metabolism products, - nulibry is indicated for the treatment of patients with molybdenum cofactor deficiency (mocd) type a.

Den europeiske union - norsk - EMA (European Medicines Agency)

actavis group ptc ehf. - memantin - alzheimers sykdom - psychoanaleptics, , andre anti-demens legemidler - behandling av pasienter med moderat til alvorlig alzheimers sykdom.

Den europeiske union - norsk - EMA (European Medicines Agency)

swedish orphan biovitrum ab - kollagenase clostridium histolyticum - dupuytren contracture - andre legemidler for forstyrrelser i muskel-skjelettsystemet - , the treatment of dupuytren’s contracture in adult patients with a palpable cord. behandling av voksne menn med peyronies sykdom med en håndgripelig plakk og kurvatur misdannelse av minst 30 grader ved start av behandling.