Synflorix Европска Унија - Исландски - EMA (European Medicines Agency)

synflorix

glaxosmithkline biologicals s.a. - pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19f - pneumococcal infections; immunization - bóluefni - virkt ónæmisaðgerðir gegn innrásarsjúkdómum og bráðum miðtaugabólgu af völdum streptococcus pneumoniae hjá ungbörnum og börnum frá sex vikum upp í fimm ára aldur. sjá kafla 4. 4 og 5. 1 í upplýsingum um vörur til að fá upplýsingar um vernd gegn tilteknum sermigerðum pneumokokkum. notkun synflorix ætti að vera ákveðin á grundvelli opinbera tillögur að taka tillit áhrif innrásar sjúkdóminn í mismunandi aldri tekur eins og l serotype faraldsfræði í mismunandi landsvæðum.

Engerix B Stungulyf, dreifa Исланд - Исландски - LYFJASTOFNUN (Icelandic Medicines Agency)

engerix b stungulyf, dreifa

glaxosmithkline pharma a/s - lifrarbólgu b yfirborðsmótefnavaki - stungulyf, dreifa

Boostrix Stungulyf, dreifa áfyllt sprauta Исланд - Исландски - LYFJASTOFNUN (Icelandic Medicines Agency)

boostrix stungulyf, dreifa áfyllt sprauta

glaxosmithkline pharma a/s - pertussis toxoid; filamentous haemagglutinin; pertactin; diphtheria toxoid; tetanus toxoid - stungulyf, dreifa - áfyllt sprauta

Boostrix Polio Stungulyf, dreifa áfyllt sprauta Исланд - Исландски - LYFJASTOFNUN (Icelandic Medicines Agency)

boostrix polio stungulyf, dreifa áfyllt sprauta

glaxosmithkline pharma a/s - diphtheria toxoid; tetanus toxoid; pertussis toxoid; filamentous haemagglutinin; pertactin; poliovirus inactivated type 1; poliovirus inactivated type 2; poliovirus inactivated type 3 - stungulyf, dreifa - áfyllt sprauta

Varilrix Stungulyfsstofn og leysir, lausn 2.000 PFU bóluefni Исланд - Исландски - LYFJASTOFNUN (Icelandic Medicines Agency)

varilrix stungulyfsstofn og leysir, lausn 2.000 pfu bóluefni

glaxosmithkline pharma a/s - varicella-zoster virus - stungulyfsstofn og leysir, lausn - 2.000 pfu bóluefni

Kalydeco Европска Унија - Исландски - EMA (European Medicines Agency)

kalydeco

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.

Orladeyo Европска Унија - Исландски - EMA (European Medicines Agency)

orladeyo

biocryst ireland limited - berotralstat dihydrochloride - ofsabjúgur, arfgengur - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Reconcile Европска Унија - Исландски - EMA (European Medicines Agency)

reconcile

forte healthcare limited - flúoxetín - sálgreiningarefni - hundar - sem aðstoð við meðferð á aðskilnaðarsjúkdómum hjá hundum sem koma fram við eyðileggingu og óviðeigandi hegðun (vöðvun og óviðeigandi hægðatregða og / eða þvaglát) og aðeins í samsetningu með hegðunarbreytingum.

Myocet liposomal (previously Myocet) Европска Унија - Исландски - EMA (European Medicines Agency)

myocet liposomal (previously myocet)

teva b.v. - doxórúbicín hýdróklóríð - brjóstakrabbamein - Æxlishemjandi lyf - myocet liposomal, ásamt cýklófosfamíði, er ætlað fyrir fyrsta lína meðferð brjóstakrabbamein í fullorðinn konur.