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

astrazeneca ab - tezepelumab - astma - legemidler for obstruktive sykdommer i luftveiene, - tezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Den europeiske union - norsk - 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.

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

biopartners gmbh - ribavirin - hepatitt c, kronisk - antivirale midler til systemisk bruk - ribavirin biopartners er indisert for behandling av kronisk hepatitt-c-virus (hcv) infeksjon hos voksne, barn tre år og eldre og ungdom, og må kun brukes som en del av et kombinasjonsregime med interferon alfa-2b. ribavirin monoterapi må ikke brukes. det foreligger ingen sikkerhets- eller effektinformasjon om bruk av ribavirin med andre former for interferon (dvs.. ikke alfa-2b). naive patientsadult patientsribavirin biopartners er angitt, i kombinasjon med interferon alfa-2b, for behandling av voksne pasienter med alle typer kronisk hepatitt c, bortsett fra genotype 1, som ikke tidligere er behandlet, uten leveren dekompensering, med forhøyede alanin aminotransferase (alt), som er positive for hepatitt c-virus ribonucleic acid (hcv-rna) (se kapittel 4. 4)barn som er tre år og eldre, og adolescentsribavirin biopartners er beregnet for bruk i en kombinasjon diett med interferon alfa-2b, for behandling av barn som er tre år og eldre og unge, som har alle typer kronisk hepatitt c, bortsett fra genotype 1, som ikke tidligere er behandlet, uten leveren dekompensering, og som er positive for hcv-rna. når du bestemmer deg for å ikke å utsette behandling til voksen alder, er det viktig å vurdere at kombinasjonsbehandling indusert en vekst hemming. den reversibilitet av vekst hemming er usikker. beslutningen om å behandle bør gjøres på en sak til sak-basis (se kapittel 4. forrige-behandling-svikt patientsadult patientsribavirin biopartners er angitt, i kombinasjon med interferon alfa-2b, for behandling av voksne pasienter med kronisk hepatitt c som tidligere har reagert (med normalisering av alt på slutten av behandlingen) til interferon alfa monoterapi, men som senere tilbakefall (se punkt 5..

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

pfizer europe ma eeig - etanercept - arthritis, psoriatic; spondylitis, ankylosing; psoriasis - immunsuppressive - revmatoid artritt;juvenil idiopatisk arthritispsoriatic leddgikt;aksial spondyloarthritis;plaque psoriasis;paediatric plakkpsoriasis.

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

sanofi winthrop industrie - clopidogrel, acetylsalicylic acid - acute coronary syndrome; myocardial infarction - antithrombotic agents - duoplavin er indisert for sekundær forebygging av atherotrombotiske hendelser hos voksne pasienter som allerede tar både klopidogrel og acetylsalisylsyre (asa). duoplavin is a fixed-dose combination medicinal product for continuation of therapy in:non st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention (pci);st segment elevation acute myocardial infarction (stemi) in patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. for ytterligere informasjon, vennligst referer til seksjon 5.

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

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - legemidler som brukes i diabetes - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

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

eli lilly nederland b.v. - dulaglutide - diabetes mellitus, type 2 - drugs used in diabetes, blood glucose lowering drugs, excl. insulins - trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for resultatene fra denne undersøkelsen med hensyn til kombinasjoner, effekter på glykemisk kontroll og kardiovaskulære hendelser, og bestandene studert, se kapittel 4. 4, 4. 5 og 5.

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

novartis europharm limited - vildagliptin - diabetes mellitus, type 2 - dipeptidyl peptidase 4 (dpp-4) inhibitors, drugs used in diabetes - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 og 5. 1 for tilgjengelige data på forskjellige kombinasjoner).

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

novartis europharm limited  - vildagliptin, metformin hydrochloride - diabetes mellitus, type 2 - legemidler som brukes i diabetes - zomarist is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate.

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

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - diabetes mellitus, type 2 - legemidler som brukes i diabetes - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 og 5. 1 for tilgjengelige data på forskjellige kombinasjoner).