Porcilis Glässer injektionsvæske, suspension Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

porcilis glässer injektionsvæske, suspension

pharmaménta aps - haemophilus parasuis serotype 5, stamme 4800, helcellekoncentrat (inaktiveret) - injektionsvæske, suspension

Vaxneuvance Den Europæiske Union - dansk - EMA (European Medicines Agency)

vaxneuvance

merck sharp & dohme b.v.  - pneumococcal polysaccharide conjugate vaccine (adsorbed) - pneumokokinfektioner - pneumococcus, purified polysaccharides antigen conjugated - vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. se afsnit 4. 4 og 5. 1 for information om beskyttelse mod specifikke pneumokokserotyper. the use of vaxneuvance should be in accordance with official recommendations.

Menjugate Kit 19+10 mikrog/dosis pulver og solvens til injektionsvæske, suspension Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

menjugate kit 19+10 mikrog/dosis pulver og solvens til injektionsvæske, suspension

gsk vaccines s.r.l. - corynebacterium diphtheriae crm-197 protein, neisseria meningitidis polysaccharid serogruppe c, stamme c11 - pulver og solvens til injektionsvæske, suspension - 19+10 mikrog/dosis

Ambirix Den Europæiske Union - dansk - EMA (European Medicines Agency)

ambirix

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - hepatitis b; hepatitis a; immunization - vacciner - ambirix er til brug i ikke-immune personer fra det ene år til og med 15 år for beskyttelse mod hepatitis a og hepatitis b-infektion. beskyttelse mod hepatitis-b-infektioner kan ikke opnås, før efter den anden dosis. derfor:ambirix bør kun anvendes, når der er en relativt lav risiko for hepatitis b infektion under vaccinationen kursus;det anbefales, at ambirix bør administreres i indstillinger, hvor afslutningen af den to-dosis vaccination naturligvis kan være sikker på,.

Soliris Den Europæiske Union - dansk - EMA (European Medicines Agency)

soliris

alexion europe sas - eculizumab - hemoglobinuri, paroxysmal - immunosuppressiva - soliris er indiceret hos voksne og børn til behandling af:paroksysmal natlig haemoglobinuria (pnh). dokumentation af klinisk fordel er påvist hos patienter med haemolysis med klinisk symptom(er) betegnende for høj sygdomsaktivitet, uanset transfusion historie (se afsnit 5. atypiske hæmolytisk uræmisk syndrom (ahus). soliris er indiceret hos voksne til behandling af:ildfaste generaliseret myasthenia gravis (gmg) i patienter, der er anti-acetylcholin-receptor (achr) antistof-positive (se afsnit 5. neuromyelitis optica spektrum forstyrrelse (nmosd) i patienter, der er anti-aquaporin-4 (aqp4) antistof-positive med en recidiverende forløbet af sygdommen.

Zerbaxa Den Europæiske Union - dansk - EMA (European Medicines Agency)

zerbaxa

merck sharp & dohme b.v.  - ceftolozane sulfat, natrium tazobactam - bakterieinfektioner - antibakterielle midler til systemisk brug, - zerbaxa is indicated for the treatment of the following infections in adults:complicated intra abdominal infections;acute pyelonephritis;complicated urinary tract infections;hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap). det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

Ultomiris Den Europæiske Union - dansk - EMA (European Medicines Agency)

ultomiris

alexion europe sas - ravulizumab - hemoglobinuri, paroxysmal - selektive immunosuppressiva - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Epysqli Den Europæiske Union - dansk - EMA (European Medicines Agency)

epysqli

samsung bioepis nl b.v. - eculizumab - hemoglobinuri, paroxysmal - immunosuppressiva - epysqli is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

Bekemv Den Europæiske Union - dansk - EMA (European Medicines Agency)

bekemv

amgen technology (ireland) uc - eculizumab - hemoglobinuri, paroxysmal - immunosuppressiva - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). dokumentation af klinisk fordel er påvist hos patienter med haemolysis med klinisk symptom(er) betegnende for høj sygdomsaktivitet, uanset transfusion historie (se afsnit 5.

Hiprabovis Somni-Lkt injektionsvæske, emulsion Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

hiprabovis somni-lkt injektionsvæske, emulsion

laboratorios hipra s.a. - haemophilus somnus, stamme bailie, inaktiveret, mannheimia haemolytica serotype a1, stamme m4/1 (inaktiveret) - injektionsvæske, emulsion - kvæg