Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1804755
Name of medicinal product: ABATIXENT
Active substances:
Estonian, English, Latin
ATC code: B01AF02
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 2,5mg
Amount in package: 20TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
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)
Last imported to Estonia: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 9, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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