Evrópusambandið - íslenska - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - aminósýra efnaskipti, innfæddir villur - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

nanotherapeutics bohumil, s.r.o. - whole virion influenza vaccine, inactivated containing antigen of strain a/california/07/2009 (h1n1)v - disease outbreaks; influenza, human; immunization - bóluefni - fyrirbyggjandi meðferð inflúensu af völdum a (h1n1) v 2009 veirunnar. celvapan ætti að vera notuð í samræmi við opinbera leiðsögn.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - Æxlishemjandi lyf - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - Ónæmisbælandi lyf - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh - mosunetuzumab - eitilæxli, follicular - antineoplastic agents, monoclonal antibodies - lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) who have received at least two prior systemic therapies.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

roche registration gmbh  - glofitamab - lymphoma, large b-cell, diffuse - Æxlishemjandi lyf - columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl), after two or more lines of systemic therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

janssen-cilag international nv - samanburður - psoriasis; arthritis, psoriatic; crohn disease; colitis, ulcerative - Ónæmisbælandi lyf - crohn-diseasestelara 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 tnfa hemla eða hafa læknis frábendingar til slíkra meðferða. sárum colitisstelara 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 líffræðileg eða hafa læknis frábendingar til slíkra meðferða. sýklum psoriasisstelara er ætlað fyrir meðferð í meðallagi til alvarlega sýklum psoriasis í fullorðnir sem tókst ekki að bregðast við, eða sem hafa frábending, eða þola öðrum almenn meðferð þar á meðal ciclosporin, stendur og psoralen útfjólubláum a. börn sýklum psoriasisstelara er ætlað fyrir meðferð í meðallagi til alvarlega sýklum psoriasis í börn og unglingur sjúklingar frá 6 ára og eldri, sem eru ekki nægilega stjórnað af, eða eru þola, hinn almenna meðferð eða phototherapies. psoriasis arthritisstelara, einn eða ásamt stendur, er ætlað fyrir meðferð virk psoriasis liðagigt í fullorðinn sjúklinga þegar svar til fyrri ekki líffræðileg sjúkdómur-að breyta verkjalyf eiturlyf (dmard) meðferð hefur verið ófullnægjandi.

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)

accord healthcare s.l.u. - degarelix acetate - blöðruhálskirtli - other hormone antagonists and related agents - degarelix accord 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)

novartis europharm limited - crizanlizumab - blóðleysi, blóðkorn - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.