Unjoni Ewropea - Daniż - EMA (European Medicines Agency)

pfizer ltd. - sitaxentan-natrium - hypertension, lunge - antihypertensiva, - behandling af patienter med pulmonal arteriel hypertension (pah) klassificeret som who funktionsklasse iii, for at forbedre træningskapaciteten. effektivitet er blevet vist ved primær lunghypertension og i lungehypertension associeret med bindevævssygdom.

Unjoni Ewropea - Daniż - 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.

Unjoni Ewropea - Daniż - EMA (European Medicines Agency)

viiv healthcare b.v. - maraviroc - hiv infektioner - antivirale midler til systemisk anvendelse - celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only ccr5-tropic hiv-1 detectable,.

Unjoni Ewropea - Daniż - EMA (European Medicines Agency)

astrazeneca ab  - metformin hydrochlorid, saxagliptin hydrochlorid - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - komboglyze er indiceret som et supplement til kost og motion for at forbedre den glykæmiske kontrol hos voksne patienter i alderen 18 år og ældre med type-2 diabetes mellitus utilstrækkeligt kontrolleret på deres maksimalt tolererede dosis af metformin alene eller dem, der allerede er behandles med en kombination af saxagliptin og metformin som separate tabletter. komboglyze er også indiceret i kombination med insulin (jeg. triple kombinationsbehandling) som supplement til diæt og motion til forbedring af glykæmisk kontrol hos voksne patienter i alderen 18 år og ældre med type 2-diabetes mellitus, når insulin og metformin alene ikke giver tilstrækkelig glykæmisk kontrol.

Unjoni Ewropea - Daniż - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil hydrochlorid - kolorektale neoplasmer - antineoplastiske midler - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

stada arzneimittel ag - pravastatinnatrium - filmovertrukne tabletter - 20 mg

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

stada arzneimittel ag - pravastatinnatrium - filmovertrukne tabletter - 40 mg

Unjoni Ewropea - Daniż - EMA (European Medicines Agency)

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - antineoplastiske midler - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above.

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

stada arzneimittel ag - montelukastnatrium - filmovertrukne tabletter - 10 mg

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

stada arzneimittel ag - montelukastnatrium - tyggetabletter - 4 mg