Европейский союз - латышский - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cistiskā fibroze - other respiratory system products - 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 un 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 un 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.

Европейский союз - латышский - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioedēma, iedzimta - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Европейский союз - латышский - EMA (European Medicines Agency)

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - antineoplastiski līdzekļi - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.

Европейский союз - латышский - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propāndiols monohidrāts - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - cukura diabēts - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. papildus citām zālēm, lai ārstētu 2. tipa cukura diabētu. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 un 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Латвия - латышский - Zāļu valsts aģentūra

teva b.v., netherlands - bortezomibs - pulveris injekciju šķīduma pagatavošanai - 3,5 mg

Европейский союз - латышский - EMA (European Medicines Agency)

eli lilly nederland b.v. - abemaciclib - krūts audzējs - antineoplastiski līdzekļi - early breast cancerverzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence (see section 5. in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist. advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.

Европейский союз - латышский - EMA (European Medicines Agency)

rhythm pharmaceuticals netherlands b.v. - setmelanotide - aptaukošanās - pretiekaisuma līdzekļi, izņemot diētas produkti - imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed bardet biedl syndrome (bbs), loss-of-function biallelic pro-opiomelanocortin (pomc), including pcsk1, deficiency or biallelic leptin receptor (lepr) deficiency in adults and children 6 years of age and above.

Европейский союз - латышский - EMA (European Medicines Agency)

eli lilly nederland b.v. - lasmiditan succinate - migrēnas traucējumi - pretsāpju līdzekļi - rayvow is indicated for the acute treatment of the headache phase of migraine attacks, with or without aura in adults.

Европейский союз - латышский - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - imūnsupresanti - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Европейский союз - латышский - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propāndiols monohidrāts - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - cukura diabēts - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. papildus citām zālēm, lai ārstētu 2. tipa cukura diabētu. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 un 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.