Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

mylan ireland limited - arsen trioxide - leukemi, promyelocytisk, akutt - antineoplastiske midler - arsen trioxide mylan er indikert for induksjon av remisjon, og konsolidering hos voksne pasienter med nydiagnostisert lav til middels risiko for akutt promyelocytic leukemi (apl) (hvite blodlegemer, ≤ 10 x 103/µl) i kombinasjon med alle trans retinsyre (atra)- tilbakefall/ildfast akutt promyelocytic leukemi (apl) (tidligere behandling burde ha inneholdt en retinoid og kjemoterapi)er karakterisert ved tilstedeværelse av t(15;17) translocation og/eller tilstedeværelse av promyelocytic leukemi/retinsyre reseptor alfa (pml/rar alpha) - genet. svarprosenten av andre akutt myelogen leukemi undertyper å arsen trioxide har ikke beenexamined.

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberkulose, multidrug-resistent - antimykobakterielle - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). det bør vurderes å offisielle retningslinjer for riktig bruk av antibakterielle midler.

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

glaxosmithkline trading services limited - sotrovimab - covid-19 virus infection - immune sera og immunglobuliner, - xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (covid-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe covid-19.

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, type 2 - legemidler som brukes i diabetes - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride mylan is indicated in combination with a sulphonylurea (i. triple kombinasjon terapi) som et tillegg til diett og trening hos pasienter ikke kontrollert på deres maksimal tolerert dose av metformin og en sulphonylurea. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist. sitagliptin/metformin hydrochloride mylan is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

sanofi b.v. - avalglucosidase alfa - glykogen storage sykdom type ii - andre alimentary tract and metabolism products, - nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with pompe disease (acid α-glucosidase deficiency).

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

sanofi b.v. - olipudase alfa - acid sphingomyelinase deficiency (asmd) type a/b or type b - andre alimentary tract and metabolism products, - xenpozyme is indicated as an enzyme replacement therapy for the treatment of non-central nervous system (cns) manifestations of acid sphingomyelinase deficiency (asmd) in paediatric and adult patients with type a/b or type b.

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - immunsuppressive - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hemoglobinuri, paroksysmal - immunsuppressive - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). dokumentasjon av klinisk nytte er vist hos pasienter med haemolysis med kliniske symptom(s) en indikasjon på høy sykdomsaktivitet, uavhengig av transfusjon historie (se punkt 5..

Avrupa Birliği - Norveççe - EMA (European Medicines Agency)

viiv healthcare b.v. - cabotegravir - hiv-infeksjoner - antivirale midler til systemisk bruk - apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (prep) to reduce the risk of sexually acquired hiv-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4. 2, 4. 4 og 5.

Norveç - Norveççe - Statens legemiddelverk

orifarm as - efavirenz - tablett, filmdrasjert - 600 mg