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

doptelet

swedish orphan biovitrum ab (publ) - avatrombopag maleate - trombocytopeni - antihemorrhagics - doptelet er indiceret til behandling af svær trombocytopeni hos voksne patienter med kronisk leversygdom, der er planlagt til at blive en invasiv procedure. doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e. kortikosteroider, immunglobuliner).

Hepatect CP 50 IE/ml infusionsvæske, opløsning Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

hepatect cp 50 ie/ml infusionsvæske, opløsning

biotest pharma gmbh - hepatitis b immunglobulin, humant, plasmaprotein, humant - infusionsvæske, opløsning - 50 ie/ml

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

zutectra

biotest pharma gmbh - human hepatitis b immunoglobulin - immunization, passive; hepatitis b; liver transplantation - immune sera og immunoglobuliner, - forebyggelse af hepatitis b virus (hbv) re-infektion hos hbsag og hbv-dna-negative voksne patienter mindst en uge efter levertransplantation for hepatitis b induceret leversvigt. hbv-dna-negativ status bør bekræftes inden for de sidste 3 måneder før olt. patienterne bør være hbsag-negative før behandlingen starter. samtidig brug af passende virostatic agenter bør betragtes som standard for hepatitis b re-infektion profylakse.

Nyxthracis (previously Obiltoxaximab SFL) Den Europæiske Union - dansk - EMA (European Medicines Agency)

nyxthracis (previously obiltoxaximab sfl)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - immune sera og immunoglobuliner, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

Flebogamma DIF (previously Flebogammadif) Den Europæiske Union - dansk - EMA (European Medicines Agency)

flebogamma dif (previously flebogammadif)

instituto grifols s.a. - humant normalt immunglobulin - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - immune sera og immunoglobuliner, - 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.

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

synagis

astrazeneca ab - palivizumab - respiratoriske syncytiale virusinfektioner - immune sera og immunoglobuliner, - synagis er indiceret til forebyggelse af alvorlige lavere-lunge-tarmkanalen sygdomme, der kræver indlæggelse forårsaget af respiratorisk syncytial virus (rsv) hos børn med høj risiko for rsv sygdom:børn født på 35 uger af drægtigheden eller mindre og mindre end seks måneder af alder ved påbegyndelsen af rsv sæsonen;børn mindre end to år, og som kræver behandling for bronkopulmonal dysplasi inden for de sidste seks måneder;børn under to år og med haemodynamically væsentlige medfødte hjertesygdomme.

Venbig 50 IE/ml pulver og solvens til infusionsvæske, opløsning Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

venbig 50 ie/ml pulver og solvens til infusionsvæske, opløsning

kedrion s.p.a. - hepatitis b immunglobulin, humant - pulver og solvens til infusionsvæske, opløsning - 50 ie/ml

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

kymriah

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - andre antineoplastiske midler - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse. • adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy. • adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy.

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

regkirona

celltrion healthcare hungary kft. - regdanvimab - covid-19 virus infection - immune sera og immunoglobuliner, - regdanvimab is indicated for the treatment of adults with coronavirus disease 2019 (covid-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19.

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

ronapreve

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - immune sera og immunoglobuliner, - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. se afsnit 4. 4 og 5.