Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ABOXOMA
Active substances:
Estonian, English, Latin
ATC code: B01AF02
Dosage form: film-coated tablet
Strength: 5mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated November 3, 2021)
Package information leaflet (PIL): EST  (last updated November 3, 2021)
Indication: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age = 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class = II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).
Safety features: Yes
Marketing authorization holder: KRKA d.d. Novo mesto 
Marketing authorization number: 1045021 
Marketing authorization issued on: November 3, 2021 
Marketing authorization expires on: November 3, 2026 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1829055  ABOXOMA  film-coated tablet  5mg 10TK  Prescription           
1829066  ABOXOMA  film-coated tablet  5mg 14TK  Prescription           
1829077  ABOXOMA  film-coated tablet  5mg 20TK  Prescription           
1829088  ABOXOMA  film-coated tablet  5mg 28TK  Prescription           
1829099  ABOXOMA  film-coated tablet  5mg 56TK  Prescription           
1829101  ABOXOMA  film-coated tablet  5mg 60TK  Prescription           
1829112  ABOXOMA  film-coated tablet  5mg 100TK  Prescription           
1829123  ABOXOMA  film-coated tablet  5mg 168TK  Prescription           
1829134  ABOXOMA  film-coated tablet  5mg 200TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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