Europeiska unionen - svenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiska medel - azacitidine accord är indicerat för behandling av vuxna patienter som inte är berättigade till hematopoetisk stamcellstransplantation (hsct) med:- intermediär-2 och hög risk myelodysplastiskt syndrom (mds) enligt internationella prognostiska scoring system (ipss), kronisk myelomonocytic leukemi (cmml) med 10-29 % märg blaster utan myeloproliferativ sjukdom, akut myeloisk leukemi (aml) med 20-30 % blaster och multi-lineage dysplasi, enligt world health organisation (who) klassificering,- aml med >30% märg blaster enligt who-klassificering.

Europeiska unionen - svenska - EMA (European Medicines Agency)

seqirus netherlands b.v. - a/darwin/9/2021 (h3n2) - like strain (a/darwin/6/2021, ivr-227) / a/victoria/4897/2022 (h1n1) pdm09-like strain (a/victoria/4897/2022, ivr-238) / b/phuket/3073/2013-like strain (b/phuket/3073/2013, bvr-1b) / influenza virus b/austria/1359417/2021-like strain (b/austria/1359417/2021, bvr-26) - influensa, människa - vacciner - profylax av influensa hos äldre (65 år och äldre). fluad tetra bör användas i enlighet med officiella rekommendationer.

Europeiska unionen - svenska - EMA (European Medicines Agency)

eli lilly nederland b.v. - insulin lispro - diabetes mellitus - läkemedel som används vid diabetes - behandling av diabetes mellitus hos vuxna, ungdomar och barn i åldern 1 år och äldre. behandling av diabetes mellitus hos vuxna.

Europeiska unionen - svenska - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - luspatercept - anemia; myelodysplastic syndromes; beta-thalassemia - andra preparat antianemic - reblozyl is indicated for the treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (mds) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5. reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non transfusion dependent beta thalassaemia (see section 5.

Europeiska unionen - svenska - EMA (European Medicines Agency)

novartis europharm limited - inclisiran - hypercholesterolemia; dyslipidemias - lipidmodifierande medel - 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - insulin aspart - diabetes mellitus - läkemedel som används vid diabetes - kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Europeiska unionen - svenska - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - pneumococcal polysaccharide conjugate vaccine (adsorbed) - pneumokockinfektioner - pneumococcus, purified polysaccharides antigen conjugated - vaxneuvance is indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. vaxneuvance is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. se avsnitt 4. 4 och 5. 1 för information om skydd mot specifika pneumokockserotyper. the use of vaxneuvance should be in accordance with official recommendations.

Europeiska unionen - svenska - EMA (European Medicines Agency)

novo nordisk a/s - semaglutide - obesity; overweight - antiobesity preparat, exkl. kost produkter - wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial body mass index (bmi) of- ≥30 kg/m² (obesity), or- ≥27 kg/m² to.

Europeiska unionen - svenska - EMA (European Medicines Agency)

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 8, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 10a, pneumococcal polysaccharide serotype 11a, pneumococcal polysaccharide serotype 12f, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 15b, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 22f, pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 33f - pneumokockinfektioner - vacciner - active immunisation for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae in individuals 18 years of age and older. se avsnitt 4. 4 och 5. 1 för information om skydd mot specifika pneumokockserotyper. apexxnar should be used in accordance with official recommendations. .

Europeiska unionen - svenska - EMA (European Medicines Agency)

eli lilly nederland b.v. - tirzepatide - diabetes mellitus, typ 2 - läkemedel som används vid diabetes - mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications- in addition to other medicinal products for the treatment of diabetes. for study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4. 4, 4. 5 och 5.