Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - mönnum papillomavirus1 tegund 16 l1 prótín, hpv tegund 18 l1 prótín - papillomavirus infections; uterine cervical dysplasia; immunization - bóluefni - cervarix er bóluefni fyrir nota frá 9 ára ár til að koma í veg forstigsbreytingar engin-kynfærum sár (legháls, sköpum, par og endaþarms) og legháls og endaþarms krabbamein causally tengjast ákveðnum krabbameins hpv (tÍÐahvÖrf) tegundir. sjá kafla 4. 4 og 5. 1 fyrir mikilvægar upplýsingar um gögnin sem styðja þessa ábendingu. notkun cervarix ætti að vera í samræmi við opinbera tillögur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - manna rotavirus, lifandi dregið úr - immunization; rotavirus infections - bóluefni - rotarix er ætlað til virkrar ónæmis hjá ungabörnum á aldrinum 6 til 24 vikna til að koma í veg fyrir magabólgu vegna rotavirus sýkingar. notkun rotarix ætti að vera byggt á opinberum meðmæli.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - dauða - mergæxli - Ónæmisbælandi lyf - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - yfirborðs mótefna gegn inflúensuveiru (haemagglutinin og neuraminidasa) á stofn a / viet nam / 1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - bóluefni - virkt bólusetning gegn h5n1 undirgerð inflúensu a veiru. , , this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain. , , prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi pasteur - neisseria meningitidis group c polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group a polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group y polysaccharide conjugated to tetanus toxoid, neisseria meningitidis group w-135 polysaccharide conjugated to tetanus toxoid - meningitis, meningococcal - bóluefni - menquadfi is indicated for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w, and y. the use of this vaccine should be in accordance with available official recommendations.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi pasteur - influenza a virus subtype h1n1 haemagglutinin, recombinant, influenza a virus subtype h3n2 haemagglutinin, recombinant, influenza b virus victoria lineage haemagglutinin, recombinant, influenza b virus yamagata lineage haemagglutinin, recombinant - inflúensu, manna - bóluefni - supemtek is indicated for active immunization for the prevention of influenza disease in adults. supemtek should be used in accordance with official recommendations.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - bóluefni - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - inflúensu, manna - veirueyðandi lyf til almennrar notkunar - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

dynavax gmbh - lifrarbólga b yfirborðs mótefnavaka - lifrarbólga b - bóluefni - heplisav b is indicated for the active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes of hepatitis b virus in adults 18 years of age and older. the use of heplisav b should be in accordance with official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with heplisav b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - veirueyðandi lyf til almennrar notkunar - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 og 5. tecovirimat siga should be used in accordance with official recommendations.