Unión Europea - islandés - EMA (European Medicines Agency)

alnylam netherlands b.v. - lumasiran sodium - hyperoxaluria, primary - Önnur meltingarvegi og efnaskipti vörur, - treatment of primary hyperoxaluria type 1 (ph1) in all age groups.

Unión Europea - islandés - EMA (European Medicines Agency)

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - svín - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies). to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies. to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies). mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

Unión Europea - islandés - EMA (European Medicines Agency)

ceva santé animale - clostridium perfringens type c, beta1 toxoid / clostridium perfringens, type a, alpha toxoid / clostridium perfringens, type a, beta2 toxoid / escherichia coli, fimbrial adhesin f4ab / escherichia coli, fimbrial adhesin f4ac / escherichia coli, fimbrial adhesin f5 / escherichia coli, fimbrial adhesin f6 - immunologicals for suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) escherichia + clostridium - svín - for the passive immunisation of progeny by active immunisation of pregnant sows and gilts to reduce:-           clinical signs (severe diarrhoea) and mortality caused by escherichia coli strains expressing the fimbrial adhesins f4ab, f4ac, f5 and f6-           clinical signs (diarrhoea during the first days of life) associated with clostridium perfringens type a expressing alpha and beta 2 toxins-           clinical signs and mortality associated with haemorrhagic and necrotising enteritis caused by clostridium perfringens type c expressing beta1 toxin.

Unión Europea - islandés - EMA (European Medicines Agency)

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.

Unión Europea - islandés - EMA (European Medicines Agency)

laboratorios hipra, s.a. - clostridioides difficile toxoid a, clostridioides difficile toxoid b, clostridium perfringens, type a, alpha toxoid - immunologicals for suidae, inactivated bacterial vaccines for pigs, clostridium - svín - for the passive immunisation of neonatal piglets by means of the active immunisation of breeding sows and gilts:- to prevent mortality and reduce clinical signs and macroscopic lesions caused by clostridioides difficile toxins a and b. - to reduce clinical signs and macroscopic lesions caused by clostridium perfringens type a, alpha toxin.

Unión Europea - islandés - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin própandiolól einhýdrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lyf notuð við sykursýki - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. auk þess önnur lyf fyrir meðferð tegund sykursýki 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Unión Europea - islandés - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin própandiolól einhýdrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lyf notuð við sykursýki - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. auk þess önnur lyf fyrir meðferð tegund sykursýki 2. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Unión Europea - islandés - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - lyf notuð við sykursýki - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Unión Europea - islandés - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lyf notuð við sykursýki - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Unión Europea - islandés - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - bluetongue-virus serotype-1 antigen, bluetongue virus serotype 8 antigen - Ónæmisfræðilegar upplýsingar - sheep; cattle - sheepactive bólusetningar af kindum og naut til að koma í veg fyrir viraemia og til að draga úr klínískum merki af völdum bluetongue veira serotypes 1, 2, 4 og/ eða 8 (sambland af hámarks 2 serotypes), virk bólusetningar af kindum og naut til að koma í veg fyrir viraemia og til að draga úr klínískum merki af völdum bluetongue veira serotypes 1,2, 4 og/ eða 8 (sambland af hámarks 2 serotypes), virk bólusetningar sauðfé til að koma í veg fyrir viraemia og til að draga úr klínískum merki af völdum bluetongue veira serotypes 1, 2, 4 og/eða 8 (sambland af hámarks 2 serotypes). cattleactive bólusetningar af nautgripum til að koma í veg fyrir viraemia af völdum bluetongue veira serotype 1, 2, 4 og/ eða 8, og til að draga úr klínískum merki af völdum bluetongue veira serotypes þegar fram í þessa tegund: serotype 1, 4 og / eða 8 (sambland af hámarks 2 serotypes). virk bólusetningar af nautgripum til að koma í veg fyrir viraemia af völdum bluetongue veira serotype 1, 2, 4 og/ eða 8, og til að draga úr klínískum merki af völdum bluetongue veira serotypes þegar fram í þessa tegund: serotype 1, 4 og / eða 8 (sambland af hámarks 2 serotypes). virk bólusetningar af kindum og naut til að koma í veg fyrir viraemia og til að draga úr klínískum merki af völdum bluetongue veira serotypes 1, 2, 4 og/eða 8 (sambland af hámarks 2 serotypes).