European Union - Icelandic - EMA (European Medicines Agency)

extrovis eu ltd. - sugammadex sodium - taugakerfi - Öll önnur lækningavörur - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

European Union - Icelandic - EMA (European Medicines Agency)

taw pharma (ireland) limited - klópídógrel hýdróklóríð - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - blóðþurrðandi lyf - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. , - adult patients suffering from acute coronary syndrome:,    - non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). ,     - st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy. , , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is), clopidogrel in combination with asa is indicated in:, - adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event.  , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. , , for further information please refer to section 5. , , ,.

European Union - Icelandic - EMA (European Medicines Agency)

gilead sciences international ltd  - emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - skert er ætlað fyrir meðferð fullorðnir sýktir hiv veira tegund 1 (hiv-1) án þekkt stökkbreytingar í tengslum við andstöðu við ekki núkleósíð vixlrita hemil (nnrti) flokki, nýrnastarfsemi eða meðferð með eviplera og með veiru hlaða ≤ 100,000 hiv-1 rna afrit/ml. eins og á við um önnur andretróveirulyf, ætti að meta sýklalyfjameðferð og / eða söguleg viðnámargögn við notkun eviplera.

European Union - Icelandic - EMA (European Medicines Agency)

novartis europharm ltd - aliskiren, meðferð - háþrýstingur - lyf sem hafa áhrif á renín-angíótensín kerfið - rasilamlo er ætlað til meðhöndlunar á nauðsynlegum háþrýstingi hjá fullorðnum sjúklingum, þar sem blóðþrýstingur er ekki nægilega stjórnað með aliskireni eða amlodipini sem er notað eitt sér.

European Union - Icelandic - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren, sýnt fram á að hjá - háþrýstingur - lyf sem hafa áhrif á renín-angíótensín kerfið - meðferð við nauðsynlegum háþrýstingi hjá fullorðnum. riprazo hb er ætlað sjúklingum sem blóðþrýstingur er ekki nægilega stjórn á aliskiren eða sýnt fram á að hjá notað einn. rirpozo hb er ætlað sem stað meðferð í sjúklingar nægilega stjórnað með aliskiren sýnt fram á að hjá, gefið samtímis, á sama skammti eins og í samsetning.

European Union - Icelandic - EMA (European Medicines Agency)

novartis europharm ltd. - aliskiren, sýnt fram á að hjá - háþrýstingur - lyf sem hafa áhrif á renín-angíótensín kerfið - meðferð við nauðsynlegum háþrýstingi hjá fullorðnum. sprimeo hb er ætlað sjúklingum sem blóðþrýstingur er ekki nægilega stjórn á aliskiren eða sýnt fram á að hjá notað einn. sprimeo hb er ætlað sem stað meðferð í sjúklingar nægilega stjórnað með aliskiren sýnt fram á að hjá, gefið samtímis, á sama skammti eins og í samsetning.

European Union - Icelandic - EMA (European Medicines Agency)

mylan ireland limited - azasitidín - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - Æxlishemjandi lyf - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

European Union - Icelandic - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - taugakerfi - Öll önnur lækningavörur - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

European Union - Icelandic - EMA (European Medicines Agency)

extrovis eu ltd. - lacosamíð - flogaveiki - antiepileptics, - lacosamide adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. lacosamide adroiq is indicated as adjunctive therapyin the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

European Union - Icelandic - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - mönnum papillomavirus1 tegund 16 l1 prótín, hpv tegund 18 l1 prótín - papillomavirus infections; uterine cervical dysplasia; immunization - bóluefni - cervarix er bóluefni fyrir nota frá 9 ára ár til að koma í veg forstigsbreytingar engin-kynfærum sár (legháls, sköpum, par og endaþarms) og legháls og endaþarms krabbamein causally tengjast ákveðnum krabbameins hpv (tÍÐahvÖrf) tegundir. sjá kafla 4. 4 og 5. 1 fyrir mikilvægar upplýsingar um gögnin sem styðja þessa ábendingu. notkun cervarix ætti að vera í samræmi við opinbera tillögur.