Данска - Дански - Lægemiddelstyrelsen (Danish Medicines Agency)

aurobindo pharma limited - simvastatin - filmovertrukne tabletter - 20 mg

Данска - Дански - Lægemiddelstyrelsen (Danish Medicines Agency)

aurobindo pharma limited - simvastatin - filmovertrukne tabletter - 40 mg

Данска - Дански - Lægemiddelstyrelsen (Danish Medicines Agency)

viatris limited - atovaquon, proguanilhydrochlorid - filmovertrukne tabletter - 250+100 mg

Европска Унија - Дански - 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.

Европска Унија - Дански - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiske midler - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Данска - Дански - Lægemiddelstyrelsen (Danish Medicines Agency)

horizon pharma ireland limited - interferon gamma-1b, human biosyntetisk - injektionsvæske, opløsning - 200 mikrogram/ml

Данска - Дански - Lægemiddelstyrelsen (Danish Medicines Agency)

mylan pharmaceuticals limited - trandolapril - kapsler, hårde - 0,5 mg

Европска Унија - Дански - 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.

Данска - Дански - Lægemiddelstyrelsen (Danish Medicines Agency)

campuspharma ab - doxylaminhydrogensuccinat, pyridoxinhydrochlorid - enterotabletter - 10+10 mg

Данска - Дански - Lægemiddelstyrelsen (Danish Medicines Agency)

campuspharma ab - foscarnetnatriumhexahydrat - infusionsvæske, opløsning - 24 mg/ml