Steglatro Evropska unija - islandščina - EMA (European Medicines Agency)

steglatro

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic sýru - sykursýki, tegund 2 - drugs used in diabetes, sodium-glucose co-transporter 2 (sglt2) inhibitors - steglatro er ætlað í fullorðnir 18 ára og eldri með tegund 2 sykursýki sem viðbót til að fæði og æfa til að bæta blóðsykursstjórnun:eitt og sér í sjúklingar sem notkun kvarta er talið óviðeigandi vegna óþol eða frábendingar. auk þess önnur lyf fyrir meðferð sykursýki.

Flucelvax Tetra Evropska unija - islandščina - EMA (European Medicines Agency)

flucelvax tetra

seqirus netherlands b.v. - a/darwin/6/2021(h3n2)-like strain (a/darwin/11/2021, wild type) / a/wisconsin/67/2022 (h1n1)pdm09-like strain (a/georgia/12/2022 cvr-167) / b/austria/1359417/2021-like strain (b/singapore/wuh4618/2021) / b/phuket/3073/2013-like virus (b/singapore/inftt-16-0610/2016, wild type) - inflúensu, manna - inflúensu, óvirkur, hættu veira eða yfirborðið antigen - prophylaxis of influenza in adults and children from 2 years of age. flucelvax fjór ætti að vera notuð í samræmi við opinbera tillögur.

Recarbrio Evropska unija - islandščina - EMA (European Medicines Agency)

recarbrio

merck sharp & dohme b.v.  - imipenem einhýdrat, cílastatín járn, relebactam einhýdrat - gramm-neikvæð bakteríusýkingum - carbapenems, antibacterials for systemic use, - recarbrio is indicated for:- treatment of hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap), in adults (see sections 4. 4 og 5. - treatment of bacteraemia that occurs in association with, or is suspected to be associated with hap or vap, in adults. - treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options (see sections 4. 2, 4. 4 og 5. Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

Enerzair Breezhaler Evropska unija - islandščina - EMA (European Medicines Agency)

enerzair breezhaler

novartis europharm limited - indacaterol, glycopyrronium bromide, mometasone - astma - lyf til veikindi öndunarvegi sjúkdómum, - enerzair breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

Bemrist Breezhaler Evropska unija - islandščina - EMA (European Medicines Agency)

bemrist breezhaler

novartis europharm limited  - indacaterol, mometasone furoate - astma - lyf til veikindi öndunarvegi sjúkdómum, - bemrist breezhaler is indicated as a maintenance   treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Adakveo Evropska unija - islandščina - EMA (European Medicines Agency)

adakveo

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.

Xofluza Evropska unija - islandščina - EMA (European Medicines Agency)

xofluza

roche registration gmbh - baloxavir marboxil - inflúensu, manna - veirueyðandi lyf til almennrar notkunar - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Leqvio Evropska unija - islandščina - EMA (European Medicines Agency)

leqvio

novartis europharm limited - inclisiran - hypercholesterolemia; dyslipidemias - lipid breytandi lyf - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin, oralone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

CircoMax Myco Evropska unija - islandščina - EMA (European Medicines Agency)

circomax myco

zoetis belgium - inactivated mycoplasma hyopneumoniae, strain p-5722-3, inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2a open reading frame 2 (orf2) protein, inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2b orf2 protein - Ónæmissjúkdómar fyrir suidae - svín (fyrir fitandi) - active immunisation of pigs against porcine circovirus type 2 to reduce viral load in blood and lymphoid tissues, fecal shedding and the lesions in lymphoid tissues associated with pcv2 infection. protection was demonstrated against porcine circovirus types 2a, 2b and 2d. active immunisation of pigs against mycoplasma hyopneumoniae to reduce the lung lesions associated with mycoplasma hyopneumoniae infection.  onset of immunity (both vaccination schedules): 3 weeks after (the last) vaccination.  duration of immunity (both vaccination schedules): 23 weeks after (the last) vaccination.  in addition, vaccination has been shown to reduce body weight gain losses under field conditions.

Ronapreve Evropska unija - islandščina - EMA (European Medicines Agency)

ronapreve

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - Ónæmiskerfið sera og mótefni, - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. sjá kafla 4. 4 og 5.