Euroopan unioni - norja - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - agenter for dermatitt, unntatt kortikosteroider - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Euroopan unioni - norja - EMA (European Medicines Agency)

roche registration gmbh - vemurafenib - melanom - antineoplastiske midler - vemurafenib er indisert i monoterapi for behandling av voksne pasienter med braf-v600-mutasjons-positiv, uoppløselig eller metastatisk melanom.

Euroopan unioni - norja - EMA (European Medicines Agency)

teva b.v.  - oksybutynin - urininkontinens, trang - urologika - symptomatisk behandling av tranginkontinens og / eller økt urinfrekvens og haster som kan oppstå hos voksne pasienter med ustabil blære.

Euroopan unioni - norja - EMA (European Medicines Agency)

takeda pharma a/s - fentanyl citrate - pain; cancer - analgetika - instanyl er indisert for behandling av gjennombrudd smerte hos voksne allerede mottar vedlikehold opioid terapi for kronisk kreft smerter. gjennombruddssmerter er en forbigående forverring av smerte som oppstår på bakgrunn av ellers kontrollert vedvarende smerte.  patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Euroopan unioni - norja - EMA (European Medicines Agency)

roche registration gmbh - metoksy polyetylen glykol-epoetin beta - anemia; kidney failure, chronic - antianemiske preparater - treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adult patients (see section 5. treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (esa) after their haemoglobin level was stabilised with the previous esa (see section 5.

Euroopan unioni - norja - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - telmisartan - hypertensjon - sirkulasjonssystem - behandling av essensiell hypertensjon hos voksne:legg på therapyonduarp er indisert hos voksne hvis blodtrykket ikke er tilstrekkelig kontrollert på amlodipine. erstatning therapyadult pasienter som mottar telmisartan og amlodipine fra separate tabletter kan i stedet få tabletter av onduarp inneholder den samme komponenten doser.

Norja - norja - Statens legemiddelverk

lantheus mi uk ltd. - bicisatdihydroklorid ad tc-99m bicisate - pulver og væske til injeksjonsvæske, oppløsning

Norja - norja - Statens legemiddelverk

ge healthcare ltd - krom (51cr) edetat - injeksjonsvæske, oppløsning - 3.7 mbq/ ml

Euroopan unioni - norja - EMA (European Medicines Agency)

sanofi winthrop industrie - insulin aspart - sukkersyke - legemidler som brukes i diabetes - truvelog mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.

Euroopan unioni - norja - EMA (European Medicines Agency)

takeda manufacturing austria ag - humant protein c - purpura fulminans; protein c deficiency - antithrombotic agents - ceprotin is indicated for prophylaxis and treatment of  purpura fulminans  coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein c deficiency.