União Europeia - islandês - EMA (European Medicines Agency)

glaxo group ltd - retapamulin - impetigo; staphylococcal skin infections - sýklalyf og krabbameinslyf til dýrafræðilegrar notkunar - short term treatment of the following superficial skin infections: , impetigo;, infected small lacerations, abrasions or sutured wounds. , sjáðu kafla 4. 4 og 5. 1 fyrir mikilvægar upplýsingar varðandi klínískum virkni retapamulin gegn mismunandi tegundir af Þegar sýkt merkið bit. Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

União Europeia - islandês - EMA (European Medicines Agency)

merck sharp & dohme b.v. - doravirine, áhrif, nýrnastarfsemi disoproxil fúmarat - hiv sýkingar - veirueyðandi lyf til meðferðar á hiv sýkingum, samsetningum - delstrigo er ætlað fyrir meðferð fullorðnir með hiv 1 án fortíðinni eða sannanir á andstöðu við nnrti flokki, áhrif, eða nýrnastarfsemi. delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with hiv-1 without past or present evidence of resistance to the nnrti class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.

União Europeia - islandês - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - berklar, fjölþol-þolir - antimycobacterials - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

União Europeia - islandês - EMA (European Medicines Agency)

zentiva, k.s. - pregabalín - anxiety disorders; epilepsy - antiepileptics, - neuropathic pain , pregabalin zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. , epilepsy , pregabalin zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. , generalised anxiety disorder , pregabalin zentiva is indicated for the treatment of generalised anxiety disorder (gad) in adults.

União Europeia - islandês - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

União Europeia - islandês - EMA (European Medicines Agency)

gilead sciences ireland uc - elvitegravir, cobicistat, meðferð með eviplera nýrnastarfsemi disoproxil fúmarat - hiv sýkingar - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - meðferð hiv veira 1 (hiv 1) sýkingu í fullorðnir aldrinum 18 ára og eldri sem eru andretróveirumeðferð-barnalegt eða ert með hiv 1 án þekkt stökkbreytingar í tengslum við andstöðu við eitthvað af þremur antiretroviral lyfjum í stribild.

União Europeia - islandês - 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.

União Europeia - islandês - EMA (European Medicines Agency)

takeda pharma a/s - brigatinib - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase alkpositive advanced nsclc previously treated with crizotinib.

União Europeia - islandês - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - blóðrauði, ofsakláði - valdar ónæmisbælandi lyf - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

União Europeia - islandês - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - krabbamein, lungnakrabbamein - Æxlishemjandi lyf - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.