Evrópusambandið - íslenska - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystic fibrosis - Önnur öndunarfæri - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - quizartinib dihydrochloride - kyrningahvítblæði, mergbólga - antineoplastic agents, protein kinase inhibitors - vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (aml) that is flt3-itd positive.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cystic fibrosis - Önnur öndunarfæri - orkambi töflur eru ætlað til meðferð fá lungnasjúkdóm (samanber) í sjúklinga á aldrinum 6 ára og eldri sem eru tilbúin fyrir f508del stökkbreytingu í cftr gene. 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ceva santé animale - florfenicol, meloxicam - amphenicols, sturtu, sýklalyf fyrir almenn nota - nautgripir - til lækninga meðferð nautgripum sjúkdóma í öndunarfærum (brd) í tengslum við hiti vegna mannheimia haemolytica, pasteurella multocida og histophilus somni næm florfenicol.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - aminósýra efnaskipti, innfæddir villur - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cystic fibrosis - Önnur öndunarfæri - 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.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

ethyx pharmaceuticals - pizotifenum maleat - húðuð tafla - 0,5 mg

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - samgena cd34+ klefi inniheldur íbúa sem inniheldur blóðmyndandi stofnfrumur transduced með lentiglobin bb305 lentiviral vektor kóðun beta-a-t87q-glóbín gene - beta-thalassemia - other hematological agents - zynteglo er ætlað fyrir meðferð sjúklinga 12 ára og eldri með blóðgjöf-háð beta thalassaemia (tdt) sem hafa ekki β0/β0 arfgerð, fyrir hvern skurðaðgerðir stafa klefi (hsc) ígræðslu er rétt en hvítra manna antigen (hla)-samsvörun tengjast hsc gjafa er ekki í boði.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

amicus therapeutics europe limited - migalastat hydrochloride - fabry sjúkdómur - migalastat - galafold er ætlað til langvarandi meðferðar hjá fullorðnum og unglingum 16 ára og eldri með staðfestri greiningu á fabry-sjúkdómum (α-galaktósíðasa a skort) og sem hefur örugg stökkbreytingu.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

avimedical b.v. - Ítrakónazól - sveppalyf fyrir almenn nota, tríazólafleiður, ítrakónazól - avian - fyrir meðferð aspergillosis og sveppasýkingu í félagi fuglar,.