Evrópusambandið - íslenska - EMA (European Medicines Agency)

instituto grifols s.a. - mönnum eðlilegt að notkun - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - Ónæmiskerfið sera og mótefni, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - lifrarbólga b yfirborðs mótefnavaka - hepatitis b; immunization - bóluefni - fendrix er ætlað í unglinga og fullorðnir frá 15 ára aldri áfram fyrir virk bólusetningar gegn lifrarbólgu b veiru-sýkingu (hbv) af völdum öllum þekktum flokkar fyrir sjúklinga með nýrnabilun (þar á meðal fyrirfram blóðskiljun og blóðskiljun sjúklingar).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

amgen europe b.v. - romiplostim - purpura, blóðflagnafæð, blóðflagnafæð - antihemorrhagics - adults:nplate is indicated for the treatment of primary immune thrombocytopenia  (itp) in adult patients who are refractory to other treatments (e. barkstera, immúnóglóbúlín). paediatrics:nplate is indicated for the treatment of chronic primary immune thrombocytopenia (itp) in paediatric patients one year of age and older who are refractory to other treatments (e. barkstera, immúnóglóbúlín).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ology bioservices ireland ltd - inflúensuveiru (heil virion, óvirkt), sem inniheldur mótefnavaka af: a / víetnam / 1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - bólusetningar gegn inflúensu - virkt bólusetning gegn h5n1 undirgerð af inflúensu a veiru. Þetta merki er byggt á immunogenicity gögn úr einstaklingar frá aldri 6 mánuðum áfram eftir gjöf tvo skammta af bóluefni tilbúinn með h5n1 undirgerð stofnar. vepacel ætti að vera notuð í samræmi við opinbera leiðsögn.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - immunization; hepatitis b; hepatitis a - bóluefni - twinrix pediatric er ætlað til notkunar hjá börnum sem ekki eru ónæmur, börn og unglingar frá einu ári til og með 15 ára, sem eru í hættu á bæði lifrarbólgu-a og lifrarbólgu-b sýkingu.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - lifrarbólgu veira (óvirkt), lifrarbólgu b yfirborðið antigen - hepatitis b; hepatitis a; immunization - bóluefni - twinrix adult er ætlað til notkunar hjá fullorðnum og unglingum sem eru ónæmur 16 ára og eldri sem eru í hættu á bæði lifrarbólgu a og lifrarbólgu b sýkingu.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited - eltrombopag - purpura, blóðflagnafæð, blóðflagnafæð - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 og 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 og 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - Ónæmisbælandi lyf - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

horizon therapeutics ireland dac - inebilizumab - neuromyelitis optica - Ónæmisbælandi lyf - uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (nmosd) who are anti-aquaporin 4 immunoglobulin g (aqp4-igg) seropositive (see section 5.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

glaxosmithkline pharma a/s - lifrarbólguveira a (deydd) - stungulyf, dreifa - 1440 elisa ein./ml