Den Europæiske Union - dansk - EMA (European Medicines Agency)

viatris healthcare limited - fenofibrat, simvastatin - dyslipidæmi - lipid modificerende midler - cholib er indiceret som tillægsbehandling til kost og motion i høj risiko for hjerte-kar-voksne patienter med blandede dyslipidaemia kan reducere triglycerider og øge hdl c niveauer, når ldl c niveauer er tilstrækkeligt kontrolleret med den tilsvarende dosis af simvastatin monoterapi.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4. 4 og 5. paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. med hensyn til beslutningen om at indlede behandling hos pædiatriske patienter, se afsnit 4. 2, 4. 4 og 5. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4. 2, 4. 4 og 5. for at hepatitis c virus (hcv) genotype specifik aktivitet, se afsnit 4. 2 og 5. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. når det besluttes at indlede behandling i barndommen, er det vigtigt at overveje, væksthæmning, der er fremkaldt af en kombination terapi. reversibilitet af væksthæmning er usikker. beslutningen om at behandling skal ske på grundlag af en individuel vurdering (se afsnit 4.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

takeda pharma a/s - brigatinib - carcinom, ikke-småcellet lunge - antineoplastiske midler - alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase alkpositive advanced nsclc previously treated with crizotinib.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

baxalta innovations gmbh - vonicog alfa - von willebrand sygdomme - antihemorrhagics - veyvondi er indiceret hos voksne (18 år og ældre) med von willebrand sygdom (vwd), når desmopressin (ddavp) behandlingen alene er ineffektive eller ikke indiceret til behandling af blødning og kirurgisk blødning - forebyggelse af kirurgiske blødninger. veyvondi bør ikke anvendes i behandling af hæmofili a.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombotiske midler - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

chanelle pharmaceuticals manufacturing ltd - meloxicam - anti-inflammatory and anti-rheumatic products, non-steroids - horses; dogs; cats; cattle; pigs - hunde: lindring af betændelse og smerte i både akutte og kroniske muskuloskeletiske lidelser. at reducere postoperativ smerte og betændelse efter ortopædisk og blødvævkirurgi. katte: at reducere postoperativ smerte efter ovariohysterektomi og mindre blødvævkirurgi. lindring af mild til moderat post-operative smerter og betændelse efter kirurgiske procedurer i katte, e. ortopædisk og bløddelskirurgi. lindring af smerter og inflammation i akutte og kroniske lidelser i bevægeapparatet hos katte. kvæg: til brug ved akut respiratorisk infektion med passende antibiotikabehandling for at reducere kliniske tegn. til brug i diarré i kombination med oral rehydratationsterapi for at reducere kliniske tegn i kalve på over en uge og unge, ikke-lakterende kvæg. til supplerende terapi til behandling af akut mastitis i kombination med antibiotikabehandling. til lindring af postoperativ smerte efter afhorning i kalve. svin: til brug i ikke-infektiøse lokomotoriske lidelser for at reducere symptomer på lameness og betændelse. til supplerende terapi ved behandling af puerperal septikæmi og toksæmi (mastitis-metritis-agalactia syndrom) med passende antibiotikabehandling. til lindring af postoperativ smerte forbundet med mindre blødt væv, såsom kastration. heste: lindring af betændelse og smertelindring i både akutte og kroniske muskuloskeletiske lidelser. til lindring af smerte forbundet med hestekolik.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

eli lilly nederland b.v. - dulaglutide - diabetes mellitus, type 2 - drugs used in diabetes, blood glucose lowering drugs, excl. insulins - trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for undersøgelsens resultater med hensyn til kombinationer, effekt på glykæmisk kontrol og hjerte-kar-hændelser, og de befolkninger, der studerede, se afsnit 4. 4, 4. 5 og 5.

Den Europæiske Union - dansk - 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

viiv healthcare b.v. - maraviroc - hiv infektioner - antivirale midler til systemisk anvendelse - celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only ccr5-tropic hiv-1 detectable,.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

reckitt benckiser healthcare (scandinavia) a/s - amylmetacresol, dichlorbenzylalkohol - sugetabletter - 0,6+1,2 mg