Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ABATIXENT
Active substances:
Apixaban
Estonian, English, Latin
ATC code: B01AF02
Dosage form: film-coated tablet
Strength: 2,5mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated September 15, 2021)
Package information leaflet (PIL): EST  (last updated November 16, 2021)
Labelling:  (last updated September 15, 2021)
Indication: Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. 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: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 1037621 
Marketing authorization issued on: September 15, 2021 
Marketing authorization expires on: September 15, 2026 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported Additional information
1804722  ABATIXENT  film-coated tablet  2,5mg 10TK  Prescription         
1804733  ABATIXENT  film-coated tablet  2,5mg 12TK  Prescription         
1804744  ABATIXENT  film-coated tablet  2,5mg 14TK  Prescription         
1804755  ABATIXENT  film-coated tablet  2,5mg 20TK  Prescription         
1804766  ABATIXENT  film-coated tablet  2,5mg 28TK  Prescription         
1804777  ABATIXENT  film-coated tablet  2,5mg 30TK  Prescription         
1804788  ABATIXENT  film-coated tablet  2,5mg 56TK  Prescription         
1804799  ABATIXENT  film-coated tablet  2,5mg 60TK  Prescription         
1804801  ABATIXENT  film-coated tablet  2,5mg 100TK  Prescription         
1804812  ABATIXENT  film-coated tablet  2,5mg 168TK  Prescription         
1804823  ABATIXENT  film-coated tablet  2,5mg 180TK  Prescription         
1804834  ABATIXENT  film-coated tablet  2,5mg 200TK  Prescription         
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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