Den Europæiske Union - dansk - 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cystisk fibrose - andet respirationssystem produkter - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cystisk fibrose - andet respirationssystem produkter - orkambi tabletter er indiceret til behandling af cystisk fibrose (cf) hos patienter i alderen 6 år og ældre, der er homozygot for f508del-mutation i cftr-genet. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cystisk fibrose - andet respirationssystem produkter - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

dompé biotec s.p.a. - darbepoetin alfa - kidney failure, chronic; anemia; cancer - antianemiske præparater - behandling af symptomatisk anæmi forbundet med kronisk nyresvigt (crf) hos voksne og pædiatriske patienter. behandling af symptomatisk anæmi hos voksne patienter med cancer i ikke-myeloide maligniteter, der modtager kemoterapi.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

pharmacosmos a/s - ferriderisomaltose - injektionsvæske, opløsning - 50 mg/ml

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

abacus medicine a/s - ferricarboxymaltose - injektions-/infusionsvæske, opløsning - 50 mg/ml

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

vifor france - ferricarboxymaltose - injektions-/infusionsvæske, dispersion - 50 mg/ml

Den Europæiske Union - dansk - EMA (European Medicines Agency)

bayer animal health gmbh - iron(iii) ion, toltrazuril - toltrazuril, kombinationer - grise (grise) - for den samtidige forebyggelse af kliniske tegn på coccidiosis (såsom diarré) i neonatale grise på bedrifter med en bekræftet historien af coccidiosis, der er forårsaget af cystoisospora suis, og forebyggelse af jernmangelanæmi.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - bluetongue-virus serotype-1 antigen, bluetongue virus serotype 8 antigen - immunologiske - sheep; cattle - sheepactive vaccination af får og kvæg for at undgå viraemia og på at reducere kliniske symptomer forårsaget af bluetongue virus serotyper 1, 2, 4 og/ eller 8 (kombination af maksimalt 2 serotyper), aktiv immunisering af får og kvæg for at undgå viraemia og på at reducere kliniske symptomer forårsaget af bluetongue virus serotyper, 1,2, 4 og/ eller 8 (kombination af maksimalt 2 serotyper), aktiv immunisering af får for at forhindre viraemia og på at reducere kliniske symptomer forårsaget af bluetongue virus serotyper 1, 2, 4 og/eller 8 (kombination af maksimalt 2 serotyper). cattleactive vaccination af kvæg for at forhindre viraemia forårsaget af bluetongue virus serotype 1, 2, 4 og/ eller 8, og på at reducere kliniske symptomer forårsaget af bluetongue virus serotyper, når de observeres i denne art: serotype 1, 4 og / eller 8 (kombination af maksimalt 2 serotyper). aktiv immunisering af kvæg for at forhindre viraemia forårsaget af bluetongue virus serotype 1, 2, 4 og/ eller 8, og på at reducere kliniske symptomer forårsaget af bluetongue virus serotyper, når de observeres i denne art: serotype 1, 4 og / eller 8 (kombination af maksimalt 2 serotyper). aktiv immunisering af får og kvæg for at undgå viraemia og på at reducere kliniske symptomer forårsaget af bluetongue virus serotyper 1, 2, 4 og/eller 8 (kombination af maksimalt 2 serotyper).