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

vyvgart

argenx - efgartigimod alfa - myasthenia gravis - immunosuppressiva - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

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

nuceiva

evolus pharma b.v. - botulinum toksin type a - aldring af huden - andre muskelrelaksantia, perifert virkende midler - midlertidig forbedring i forekomsten af moderat til svær lodrette linjer mellem øjenbrynene set på maksimalt rynke panden (glabellar linjer), når sværhedsgraden af ovenstående facial linjer har en vigtig psykologisk effekt hos voksne under 65 år.

Nobivac Piro Den Europæiske Union - dansk - EMA (European Medicines Agency)

nobivac piro

intervet international bv - babesia canis, inactivated, babesia rossi, inactivated - immunologier til canidae - hunde - til aktiv immunisering af hunde på seks måneder eller ældre mod babesia canis for at reducere sværhedsgraden af ​​kliniske tegn forbundet med akut babesiose (b. canis) og anæmi som målt ved pakket cellevolumen. immunitetens begyndelse: tre uger efter grundvaccinationen. immunitetens varighed: seks måneder efter den sidste (re) vaccination.

Porcilis PCV M Hyo Den Europæiske Union - dansk - EMA (European Medicines Agency)

porcilis pcv m hyo

intervet international b.v. - porcint circovirus type 2 (pcv2) orf2 subunit-antigen, mycoplasma hyopneumoniae j stamme inaktiverede - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - svin (slagtekyllinger) - til aktiv immunisering af svin for at reducere viraemia, virus belastning i lungerne og lymfoide væv, virus kaste forårsaget af porcint circovirus type 2 (pcv2) infektion, og sværhedsgraden af lunge læsioner forårsaget af mycoplasma hyopneumoniae infektion. for at reducere tabet af daglig vægtforøgelse i efterbehandlingstiden i lyset af infektioner med mycoplasma hyopneumoniae og / eller pcv2 (som observeret i feltundersøgelser).

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

startvac

laboratorios hipra s.a. - escherichia coli j5 inactivated, staphylococcus aureus (cp8) strain sp 140 inactivated, expressing slime-associated antigenic complex - immunologiske stoffer til bovidae - kvæg (køer og kvier) - til besætning vaccination af sunde køer og kvier, i malkekvæg besætninger med tilbagevendende problemer med mastitis, at reducere forekomsten af subklinisk mastitis, og forekomsten og sværhedsgraden af den kliniske tegn på klinisk mastitis forårsaget af staphylococcus aureus, coliforme bakterier og coagulase-negative stafylokokker. det fulde immuniseringsskema inducerer immunitet fra ca. dag 13 efter den første injektion til ca. dag 78 efter den tredje injektion (ækvivalent med 130 dage efter fødslen).

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.

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.

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

jayempi

nova laboratories ireland limited - azathioprine - graft afvisning - immunosuppressiva - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Kentera (previously Oxybutynin Nicobrand) Den Europæiske Union - dansk - EMA (European Medicines Agency)

kentera (previously oxybutynin nicobrand)

teva b.v.  - oxybutynin - urininkontinens, urge - urologicals - symptomatisk behandling af tranginkontinens og / eller øget urinfrekvens og haster som kan forekomme hos voksne patienter med ustabil blære.

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

rasitrio

novartis europharm ltd. - aliskiren, amlodipin, hydrochlorthiazid - forhøjet blodtryk - kardiovaskulære system - rasitrio er indiceret til behandling af essentiel hypertension som substitution terapi hos voksne patienter, hvis blodtryk er tilstrækkeligt kontrolleret på kombinationen af aliskiren, amlodipin og hydrochlorthiazid givet samtidigt på den samme dosis niveau som i kombinationen.