Unia Europejska - duński - EMA (European Medicines Agency)

astrazeneca ab - exenatid - diabetes mellitus, type 2 - narkotika anvendt i diabetes - bydureon er angivet i voksne over 18 år og ældre med type 2-diabetes mellitus til forbedring af glykæmisk kontrol i kombination med andre glukose sænkende lægemidler, når behandlingen er i brug, sammen med diæt og motion ikke giver tilstrækkelig glykæmisk kontrol (se afsnit 4. 4, 4. 5 og 5. 1 for tilgængelige data på forskellige kombinationer). bydureon er indiceret til behandling af type 2-diabetes mellitus i kombination med:metforminsulphonylureathiazolidinedionemetformin og sulphonylureametformin og thiazolidinedionein voksne, som ikke har opnået tilstrækkelig glykæmisk kontrol på maksimalt tolereret dosis af disse mundtlige behandlinger.

Dania - duński - Lægemiddelstyrelsen (Danish Medicines Agency)

krka d.d. novo mesto - amlodipinbesilat, hydrochlorthiazid, valsartan - filmovertrukne tabletter - 5+160+12,5 mg

Dania - duński - Lægemiddelstyrelsen (Danish Medicines Agency)

bristol-myers squibb ab - triamcinolonacetonid - injektionsvæske, suspension - 40 mg/ml

Dania - duński - Lægemiddelstyrelsen (Danish Medicines Agency)

teva b.v. - bicalutamid - filmovertrukne tabletter - 50 mg

Dania - duński - Lægemiddelstyrelsen (Danish Medicines Agency)

krka sverige ab - celecoxib - kapsler, hårde - 100 mg

Dania - duński - Lægemiddelstyrelsen (Danish Medicines Agency)

medac, gesellschaft für klinische spezialpräparate mbh - sulfasalazin - enterotabletter - 500 mg

Dania - duński - Lægemiddelstyrelsen (Danish Medicines Agency)

2care4 aps - triamcinolonacetonid - injektionsvæske, suspension - 40 mg/ml

Dania - duński - Lægemiddelstyrelsen (Danish Medicines Agency)

orifarm a/s - triamcinolonacetonid - injektionsvæske, suspension - 40 mg/ml

Unia Europejska - duński - EMA (European Medicines Agency)

ipsen pharma - cabozantinib - thyroid neoplasms - antineoplastiske midler - behandling af voksne patienter med progressiv, inoperabel lokalt fremskreden eller metastatisk medullær thyroid carcinoma.

Unia Europejska - duński - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystisk fibrose - andet respirationssystem produkter - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 og 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 og 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.