Európska únia - dánčina - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastiske midler - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Európska únia - dánčina - EMA (European Medicines Agency)

astrazeneca ab - acalabrutinib - leukæmi, lymfocytisk, kronisk, b-celle - antineoplastic agents, protein kinase inhibitors, - calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll). calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.

Európska únia - dánčina - EMA (European Medicines Agency)

pinax pharma gmbh - ioflupane (123i) - radionuclide imaging; dementia; movement disorders - diagnostiske radioaktive lægemidler - dette lægemiddel er kun til diagnostisk brug. celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:in adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic parkinson’s disease, multiple system atrophy and progressive supranuclear palsy.  celsunax is unable to discriminate between parkinson's disease, multiple system atrophy and progressive supranuclear palsy. hos voksne patienter, til at hjælpe med at differentiere sandsynligt, demens med lewy organer fra alzheimers sygdom.  celsunax is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.

Európska únia - dánčina - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - multipel sklerose, recidiverende-remitterende - immunosuppressiva - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Európska únia - dánčina - EMA (European Medicines Agency)

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - immune sera og immunoglobuliner, - 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. se afsnit 4. 4 og 5.

Európska únia - dánčina - EMA (European Medicines Agency)

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - antineoplastiske midler - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above.

Európska únia - dánčina - EMA (European Medicines Agency)

astrazeneca ab - nirsevimab - immune sera og immunoglobuliner, - beyfortus is indicated for the prevention of respiratory syncytial virus (rsv) lower respiratory tract disease in neonates and infants during their first rsv season. beyfortus should be used in accordance with official recommendations.

Európska únia - dánčina - EMA (European Medicines Agency)

roche registration gmbh - faricimab - wet macular degeneration; macular edema; diabetes complications - oftalmologiske - vabysmo is indicated for the treatment of adult patients with:neovascular (wet) age-related macular degeneration (namd),visual impairment due to diabetic macular oedema (dme).

Európska únia - dánčina - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - narkotika anvendt i diabetes - 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.

Európska únia - dánčina - EMA (European Medicines Agency)

cz veterinaria s.a. - bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated] - immunologiske - sheep; cattle - sheepactive vaccination mod bluetongue virus serotype 8 for at forhindre viraemia og til at reducere kliniske tegn. immunitetens begyndelse: 20 dage efter anden dosis. immunitetens varighed: 1 år efter anden dosis. cattleactive vaccination mod bluetongue virus serotype 8 for at forhindre viraemia. immunitetens begyndelse: 31 dage efter anden dosis. immunitetens varighed: 1 år efter anden dosis.