Европейски съюз - фински - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - kystinen fibroosi - muut hengitysteiden tuotteet - 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 ja 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 ja 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.

Европейски съюз - фински - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - aminohappoaineenvaihdunta, synnynnäiset virheet - 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.

Европейски съюз - фински - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - kystinen fibroosi - muut hengitysteiden tuotteet - 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.

Европейски съюз - фински - EMA (European Medicines Agency)

pfizer europe ma eeig - nonacog alfa - hemofilia b - hemostaatit - verenvuodon hoito ja ehkäisy hemofilia b-potilailla (synnynnäinen tekijä ix: n vajaus).

Европейски съюз - фински - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - autologisen cd34+ - solujen rikastettu väestöstä, joka sisältää hematopoieettisten kantasolujen transduced kanssa lentiglobin bb305 lentiviral vector koodaus beta-a-t87q-globiinigeenin - beeta-talassemia - other hematological agents - zynteglo on tarkoitettu niiden potilaiden hoitoon 12-vuotiaille ja sitä vanhemmille, transfusion-dependent β-talassemia (tdt), jotka eivät ole β0/β0 genotyyppi, joille hematopoieettisten kantasolujen (hsc) elinsiirrot on aiheellista, mutta ihmisten niiden erittelylaskenta antigeenin (hla)-sovitettu liittyvät hsc luovuttaja ei ole saatavilla.

Европейски съюз - фински - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - muut hermoston huumeet - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Европейски съюз - фински - EMA (European Medicines Agency)

biomarin international limited - valoctocogene roxaparvovec - hemostaatit - treatment of severe haemophilia a (congenital factor viii deficiency) in adult patients without a history of factor viii inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (aav5).

Европейски съюз - фински - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulin human - diabetes mellitus - diabeetilla käytettävät lääkkeet - diabetes mellitus, johon tarvitaan insuliinin hoitoa. insuman rapid on myös hoitoon hyperglycaemic koomaan ja ketoasidoosi sekä saavuttaa ennalta, sisäinen ja leikkauksen vakautus potilailla, joilla on diabetes mellitus.

Европейски съюз - фински - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - pandemiainfluenssarokote (h5n1) (virusfragmentit, inaktivoitu, adjuvanttia sisältävä rokote) - influenza, human; immunization; disease outbreaks - rokotteet - influenssan ennaltaehkäisy virallisesti ilmoitetussa pandemiatilanteessa. pandemia-influenssa rokotetta tulee käyttää virallisen ohjeistuksen mukaisesti.

Европейски съюз - фински - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - paklitakseli - breast neoplasms; pancreatic neoplasms; carcinoma, non-small-cell lung - antineoplastiset aineet - abraxanea monoterapiana on tarkoitettu metastasoituneen rintasyövän hoidossa aikuisilla potilailla, jotka eivät ole ensilinjan hoito metastaattinen tauti ja joille vakiintunut antrasykliiniä sisältävä hoito ei ole indisoitu. abraxane yhdistelmänä gemsitabiinin kanssa on tarkoitettu ensilinjan hoito aikuisilla potilailla, joilla on metastaattinen haiman adenokarsinooma. abraxane yhdistelmänä karboplatiinin kanssa on tarkoitettu ensilinjan hoito ei-pienisoluisen keuhkosyövän hoitoon aikuisille potilaille, jotka eivät ole ehdokkaita mahdollisesti parantava leikkaus ja/tai sädehoito.