Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharmaceuticals international ag - icatibant - ofsabjúgur, arfgengur - hjarta meðferð - firazyr er ætlað til meðferðar við bráðri árás arfgengs ofsabjúgs (hae) hjá fullorðnum (með skort á c1-esterasa-hemlum).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - degarelix - blöðruhálskirtli - innkirtla meðferð - firmagon is a gonadotrophin releasing hormone (gnrh) antagonist indicated:- for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck europe b.v.  - lútrópín alfa - ovulation induction; infertility, female - hormón kynlíf og stillum kynfæri - luveris í samsettri meðferð með eggbúsörvandi hormón (fsh) er ráðlagt til að örva þróun eggbús hjá konum með alvarlega lúteiniserandi hormón (lh) og fsh skort. Í klínískum rannsóknum, þessar sjúklinga sem voru skilgreind af innræn blóðvatn ace stigi.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck europe b.v.  - follitropin alfa, lutropin alfa - Ófrjósemi, kvenkyns - hormón kynlíf og stillum kynfæri - voru er ætlað fyrir örvun tíðahvörf þróun í konur með alvarlega gulbúsörvandi-hormón (ace) og anti-örvandi-hormón skort. Í klínískum rannsóknum, þessar sjúklinga sem voru skilgreind af innræn blóðvatn ace stigi < 1. 2 ae / l.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

astellas pharma europe b.v. - enzalutamíð - blöðruhálskirtli - innkirtla meðferð - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bayer ag - darolutamide - stækkun Æxli, gelding-Þola - innkirtla meðferð - nubeqa is indicated for the treatment of adult men with- non metastatic castration resistant prostate cancer (nmcrpc) who are at high risk of developing metastatic disease (see section 5. - metastatic hormone sensitive prostate cancer (mhspc) in combination with docetaxel and androgen deprivation therapy (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

nova laboratories ireland limited - azathioprine - graft rejection - Ónæmisbælandi lyf - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - ofsabjúgur, arfgengur - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

mylan ireland limited - fingolimod stutt og long-term - heila-og mænusigg, köstum tilkynnt - Ónæmisbælandi lyf - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 og 5. 1)orpatients með ört vaxandi alvarlega köstum skil heila-og mænusigg skilgreind af 2 eða meira að slökkva köst í eitt ár, og með 1 eða meira skuggaefna efla sár á heilanum segulÓmun eða mikil aukning í t2 sár álag eins og miðað við fyrri undanförnum segulÓmun.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - heila-og mænusigg, köstum tilkynnt - Ónæmisbælandi lyf - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).