Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited - sacubitril, valsartan - hjartabilun - ace ii hemla, önnur sturtu, umboðsmenn starfa á renín-ace kerfi - paediatric heart failureentresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction. adult heart failureentresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

takeda pharma a/s - vedolizumab - colitis, ulcerative; crohn disease - valdar ónæmisbælandi lyf - sárum colitisentyvio er ætlað fyrir meðferð fullorðinn sjúklinga með nokkuð að alvarlega virka sárum niðurgang sem hafa verið ófullnægjandi að bregðast við, misst að bregðast við, eða voru óþol að annaðhvort hefðbundin meðferð eða æxli drep þáttur alfa (tnfa) hemla. crohn-diseaseentyvio er ætlað fyrir meðferð fullorðinn sjúklinga með nokkuð að alvarlega virka crohn-sjúkdóm sem hafa verið ófullnægjandi að bregðast við, misst að bregðast við, eða voru óþol að annaðhvort hefðbundin meðferð eða æxli drep þáttur alfa (tnfa) hemla. pouchitisentyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir - lifrarbólga c, langvinn - veirueyðandi lyf til almennrar notkunar - epclusa is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients 3 years of age and older (see sections 4. 2, 4. 4 og 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

hexal ag - epóetín alfa - anemia; kidney failure, chronic; cancer - sýklalyf - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. meðferð blóðleysi og lækkun blóðgjöf kröfur í fullorðinn sjúklingar fá lyfjameðferð fyrir traustan æxli, illkynja eitlaæxli eða margar forráðamenn, og í hættu á blóðgjöf eins og metnar af sjúklings almennt stöðu (e. hjarta stöðu, fyrirfram núverandi blóðleysi á að byrja í lyfjameðferð).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, kvarta stutt og long-term - sykursýki, tegund 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - eucreas is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

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)

instituto grifols s.a. - mönnum eðlilegt að notkun - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - Ónæmiskerfið sera og mótefni, - 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin - sykursýki, tegund 2 - lyf notuð við sykursýki - vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

actavis group ptc ehf    - pioglitazón hýdróklóríð - sykursýki, tegund 2 - lyf notuð við sykursýki - pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below:as monotherapy:in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;as dual oral therapy in combination with:metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;as triple oral therapy in combination with:metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. lyfleysu er einnig ætlað fyrir ásamt insúlín í tegund-2 sykursýki fullorðinn sjúklinga með ófullnægjandi blóðsykursstjórnun á insúlín fyrir hvern kvarta er óviðeigandi vegna frábendingar eða óþol. eftir hafin með lyfleysu, sjúklingar ætti að vera metið eftir 3 til 6 mánuði að meta fullnægjandi að bregðast við meðferð (e. lækkun í hba1c). Í sjúklingum sem ekki að sýna nægilegt svar, engar upplýsingar ætti að hætta. Í ljósi væntanlegra áhættu með langvarandi meðferð, ávísun ætti að staðfesta á síðari lífi umsagnir að njóta góðs af lyfleysu er viðhaldið.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - Æxlishemjandi lyf - glivec is indicated for the treatment of , adult and paediatric patients with newly diagnosed philadelphia-chromosome (bcr-abl)-positive (ph+) chronic myeloid leukaemia (cml) for whom bone-marrow transplantation is not considered as the first line of treatment;, adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult and paediatric patients with newly diagnosed philadelphia-chromosome-positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic / myeloproliferative diseases (mds / mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and / or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfra rearrangement. , Áhrif glivec á niðurstöðu bein-marrow ígræðslu hefur ekki verið ákveðið. glivec is indicated for: , the treatment of adult patients with kit (cd 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (gist);, the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. sjúklingar sem hafa lítil eða mjög lítil hætta á endurkomu ætti ekki að fá viðbótar meðferð;, meðferð fullorðinn sjúklinga með unresectable dermatofibrosarcoma protuberans (dfsp) og fullorðinn sjúklinga með endurteknum og / eða sjúklingum dfsp sem eru ekki rétt fyrir aðgerð. Í fullorðna og börn sjúklingar, skilvirkni glivec er byggt á almenna blóðfræðileg og litningasvörun svar verð og framgangi-frjáls að lifa í cml, á blóðfræðileg og litningasvörun svar verð í ph+ allt, stýrð útgjöld / mpd, á blóðfræðileg svar verð í hann / hÁtÍÐ og á markmið svar verð í fullorðinn sjúklinga með unresectable og / eða sjúklingum gist og dfsp og á endurkomu-frjáls að lifa í viðbótar gist. reynslu með glivec í sjúklinga með stýrð útgjöld / mpd tengslum við pdgfr gene aftur fyrirkomulag er mjög takmarkað (sjá kafla 5. nema í nýlega greind langvarandi áfanga cml, það eru ekki stjórnað rannsóknir sýna klínískum gagnast eða jókst að lifa fyrir þessum sjúkdómum.