Evrópusambandið - íslenska - EMA (European Medicines Agency)

gilead sciences ireland uc - ledipasvir, sofosbuvir - lifrarbólga c, langvinn - veirueyðandi lyf til almennrar notkunar - harvoni is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 og 5. fyrir lifrarbólgu c veira (hcv) arfgerð-sérstakur starfsemi sjá kafla 4. 4 og 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm limited - eltrombopag - purpura, blóðflagnafæð, blóðflagnafæð - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 og 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 og 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

eli lilly nederland b.v. - dúlaglútíð - sykursýki, tegund 2 - drugs used in diabetes, blood glucose lowering drugs, excl. insulins - trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. fyrir rannsókn árangri með tilliti til sturtu, áhrif á blóðsykursstjórnun og hjarta viðburði, og íbúa rannsakað, sjáðu kafla 4. 4, 4. 5 og 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

pfizer ireland pharmaceuticals - avibactam sodium, ceftazidime pentahydrate - pneumonia, bacterial; soft tissue infections; pneumonia; urinary tract infections; gram-negative bacterial infections - sýklalyf fyrir almenn nota, - zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:complicated intra-abdominal infection (ciai)complicated urinary tract infection (cuti), including pyelonephritishospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap)treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. zavicefta is also indicated for the treatment of infections due to aerobic gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

amryt pharmaceuticals dac - metreleptin - fitukyrkingi, fjölskyldu hluta - Önnur meltingarvegi og efnaskipti vörur, - myalepta er ætlað sem viðbót til að mataræði eins og skipti meðferð til að meðhöndla fylgikvillar ki skort í fitukyrkingi (ld) sjúklingar:með staðfest meðfædda almenn ld (berardinelli-seip heilkenni) eða keypt almenn ld (lawrence heilkenni) í fullorðna og börn 2 ára aldri og abovewith staðfest ættingja hluta ld eða keypt hluta ld (barraquer-simons heilkenni), í fullorðna og börn 12 ára og eldri fyrir hvern standard meðferðir hefur ekki tekist að ná fullnægjandi efnaskiptum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

sanofi winthrop industrie - insúlín aspart - sykursýki - lyf notuð við sykursýki - insulin aspart sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - eitilfrumukrabbamein, mantle-cell - Æxlishemjandi lyf - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor. acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

rhythm pharmaceuticals netherlands b.v. - setmelanotide - offita - Ónæmiskerfi, þó ekki mataræði - imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed bardet biedl syndrome (bbs), loss-of-function biallelic pro-opiomelanocortin (pomc), including pcsk1, deficiency or biallelic leptin receptor (lepr) deficiency in adults and children 6 years of age and above.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novo nordisk a/s - somapacitan - vöxtur - hinsveiflur og heilahimnubólur og hliðstæður - sogroya is indicated for the replacement of endogenous growth hormone (gh) in children  aged 3  years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric ghd), and in adults with growth hormone deficiency (adult ghd).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - insúlín aspart - sykursýki - lyf notuð við sykursýki - kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.