Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

n.v. organon* - desogestrelum inn; ethinylestradiolum inn - tafla - 150 míkróg/20 míkróg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

leo pharma a/s* - acidum fusidicum inn; hydrocortisonum acetat - krem - 20 + 10 mg

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

merck sharp & dohme b.v. - pneumococcal polysaccharide danish types 1,2,3,4,5,6b,7f,8,9n,9v,10a,11a,12f,14,15b,17f,18,c,19a, 19f,20,22f,23f,33f - stungulyf, lausn í áfylltri sprautu - 25 míkróg

Evrópusambandið - íslenska - 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. , , ,.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

gilead sciences ireland uc - meðferð með eviplera nýrnastarfsemi alafenamide - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (hiv-1).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanediol einhýdrat, kvarta stutt og long-term - sykursýki, tegund 2 - lyf notuð við sykursýki - tegund sykursýki 2 mellitusfor meðferð nægilega stjórnað tegund 2 sykursýki sem viðbót til að fæði og æfa. eitt og sér þegar sjúklingar er talið óviðeigandi vegna óþol. auk þess önnur lyf fyrir meðferð tegund sykursýki 2. fyrir rannsókn árangri með tilliti til sambland af meðferð, áhrif á blóðsykursstjórnun og hjarta viðburði, og íbúa rannsakað, sjáðu kafla 4. 4, 4. 5 og 5. 1 sykursýki mellitusedistride er ætlað í fullorðnir fyrir meðferð nægilega stjórnað tegund 1 sykursýki sem viðbót til að insúlín í sjúklinga með Ætti stærri 27 kg/m 2, þegar insúlín einn veitir ekki fullnægjandi blóðsykursstjórnun þrátt fyrir bestu insúlín meðferð.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

baxalta innovations gmbh - mönnum eðlilegt að notkun - Ónæmisfræðilegir skortsyndar - Ónæmiskerfið sera og mótefni, - skipti meðferð hjá fullorðnum, börn og unglingar (0-18 ár) í aðal ónæmisgalla heilkennum með skert mótefni framleiðslu. hypogammaglobulinaemia og endurtekin bakteríusýkingum í sjúklinga með langvarandi eitilfrumuhvítblæði (cll), í hvern fyrirbyggjandi sýklalyf hafa mistókst eða eru ætlað. hypogammaglobulinaemia og endurtekin bakteríusýkingum í margar forráðamenn (mm) sjúklingar. hypogammaglobulinaemia í sjúklingar fyrir og eftir ósamgena blóðmyndandi stafa klefi ígræðslu (hsct).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. nema í nýlega greind langvarandi áfanga cml, það eru ekki stjórnað rannsóknir sýna klínískum gagnast eða jókst að lifa fyrir þessum sjúkdómum. .

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis europharm ltd - valsartan, amlodipine (as amlodipine besilate) - háþrýstingur - lyf sem hafa áhrif á renín-angíótensín kerfið - meðferð við nauðsynlegum háþrýstingi. mælt er ætlað sjúklingum sem blóðþrýstingur er ekki nægilega stjórn á meðferð eða valsartan sér.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - skert umbrot brómíð - lungnasjúkdómur, langvarandi hindrandi - lyf til veikindi öndunarvegi sjúkdómum, - tilkynnt sem viðhaldsberkjuvíkkandi meðferð til að létta einkenni hjá fullorðnum sjúklingum með langvinna lungnateppu (copd).