Euroopan unioni - norja - EMA (European Medicines Agency)

novartis europharm limited - indacaterol, glycopyrronium bromide, mometasone - astma - legemidler for obstruktive sykdommer i luftveiene, - enerzair breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

Euroopan unioni - norja - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol, mometasone furoate - astma - legemidler for obstruktive sykdommer i luftveiene, - bemrist breezhaler is indicated as a maintenance   treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Euroopan unioni - norja - EMA (European Medicines Agency)

novartis europharm limited - glycopyrronium bromide, indacaterol (acetate), mometasone furoate - astma - legemidler for obstruktive sykdommer i luftveiene, - maintenance treatment of asthma in adults whose disease is not adequately controlled.

Euroopan unioni - norja - EMA (European Medicines Agency)

novartis europharm limited - crizanlizumab - anemi, sickle cell - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Euroopan unioni - norja - EMA (European Medicines Agency)

novartis europharm limited - inclisiran - hypercholesterolemia; dyslipidemias - lipid modifiserende midler - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin, oralone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Euroopan unioni - norja - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karsinom, ikke-småcellet lunge - antineoplastiske midler - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Euroopan unioni - norja - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - radionuklide bildebehandling - diagnostiske radiopharmaceuticals - dette legemidlet er kun til diagnostisk bruk. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

Euroopan unioni - norja - EMA (European Medicines Agency)

novartis europharm limited  - lutetium (177lu) vipivotide tetraxetan - prostatic neoplasmer, kastrering-resistant - terapeutisk radiofarmaka - pluvicto in combination with androgen deprivation therapy (adt) with or without androgen receptor (ar) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with ar pathway inhibition and taxane based chemotherapy.

Euroopan unioni - norja - EMA (European Medicines Agency)

novartis europharm limited - telbivudin - hepatitt b, kronisk - nukleosid og nukleotid revers transkriptase inhibitorer - sebivo er indisert for behandling av kronisk hepatitt b i voksen pasienter med kompensert leversykdom og bevis av viral replikasjon, vedvarende opphøyet serum alanin aminotransferase (alt) nivåer og histologiske bevis for aktive betennelse og/eller fibrose. initiering av sebivo behandling bør vurderes ved bruk av en alternativ antiviralt middel med en høyere genetisk barriere til motstand er ikke tilgjengelig eller hensiktsmessig.

Euroopan unioni - norja - EMA (European Medicines Agency)

novartis europharm limited - everolimus - tuberøs sklerose - antineoplastiske midler - nedsatt angiomyolipoma forbundet med tuberous sklerose kompleks (tsc)votubia er indisert for behandling av voksne pasienter med nedsatt angiomyolipoma forbundet med tuberous sklerose kompleks (tsc) som er i risiko for komplikasjoner (basert på faktorer som tumorstørrelse eller tilstedeværelsen av en aneurisme, eller tilstedeværelsen av en eller flere bilaterale svulster), men som ikke krever umiddelbar operasjon. bevisene er basert på en analyse av endring i summen av angiomyolipoma volum. subependymal gigantiske celle astrocytom (sega) forbundet med tuberous sklerose kompleks (tsc)votubia er indisert for behandling av pasienter med subependymal gigantiske celle astrocytom (sega) forbundet med tuberous sklerose kompleks (tsc) som krever terapeutisk intervensjon, men er ikke mottagelig for kirurgi. bevisene er basert på en analyse av endring i sega volum. ytterligere klinisk nytte, for eksempel forbedring i sykdom‑relaterte symptomer, er ikke blitt påvist.