Jardiance Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

jardiance

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - lyf notuð við sykursýki - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Maci Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

maci

vericel denmark aps - autologous cultured chondrocytes - brot, brjósk - Önnur lyf við sjúkdómum í stoðkerfi - viðgerðir á brjóskum á brjósti á einkennum.

Mycophenolate mofetil Teva Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

mycophenolate mofetil teva

teva pharma b.v. - mýcófenólat mofetil - graft rejection - Ónæmisbælandi lyf - mycofenolatmofetils mg í fram ásamt ciclosporin og aðferðir til að fyrirbyggja bráð grætt höfnun í sjúklingar fá ósamgena skert, hjarta eða lifur ígræðslu.

Myfenax Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

myfenax

teva b.v. - mýcófenólat mofetil - graft rejection - Ónæmisbælandi lyf - myfenax er ætlað í samsettri meðferð með ciklósporíni og barksterum til að fyrirbyggja bráðan höfnun ígræðslu hjá sjúklingum sem fá samsetta nýrna-, hjarta- eða lifrarígræðslur.

Myocet liposomal (previously Myocet) Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

myocet liposomal (previously myocet)

teva b.v. - doxórúbicín hýdróklóríð - brjóstakrabbamein - Æxlishemjandi lyf - myocet liposomal, ásamt cýklófosfamíði, er ætlað fyrir fyrsta lína meðferð brjóstakrabbamein í fullorðinn konur.

Nonafact Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

nonafact

sanquin plasma products b.v. - storkuþáttur ix hjá mönnum - hemophilia b - antihemorrhagics, - meðferð og fyrirbyggja blæðingar í sjúklinga með dreyrasýki b (meðfædda þáttur laga skort).

Nuwiq Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

nuwiq

octapharma ab - simoctocog alfa - hemophilia a - blóðstorkunarþættir - meðferð og fyrirbyggjandi blæðingar hjá sjúklingum með dreyrasýki a (meðfæddan storkuþætti viii skortur). nuwiq getur verið notað fyrir öllum aldri tekur.

Obizur Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

obizur

baxalta innovations gmbh - susoctocog alfa - hemophilia a - antihemorrhagics - meðferð blæðingarþáttar hjá sjúklingum með fengið dreyrasýki af völdum mótefna gegn factor viii. obizur er ætlað fullorðnum.

Ofev Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

ofev

boehringer ingelheim international gmbh - nintedanib - idiopathic lungvefi - Æxlishemjandi lyf - ofev er ætlað fullorðnum til meðferðar við lungnablóðfrumnafæð (ipd).

Prezista Umoja wa Ulaya - Kiaisilandi - EMA (European Medicines Agency)

prezista

janssen-cilag international nv - darunavir - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.