Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol, mometasone furoate - astma - lyf til veikindi öndunarvegi sjúkdómum, - bemrist breezhaler is indicated as a maintenance   treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

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)

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)

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) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

axunio pharma gmbh - pirfenidone - idiopathic lungvefi - Ónæmisbælandi lyf - pirfenidone aet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - Ónæmisbælandi lyf - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lyf notuð við sykursýki - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

teva sweden ab - montelukastum natríum - filmuhúðuð tafla - 10 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

williams & halls ehf.* - paracetamolum inn - endaþarmsstíll - 125 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

williams & halls ehf - paracetamolum inn - tafla - 500 mg