ABATIXENT
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1804924
Name of medicinal product:
ABATIXENT
Active substances:
Apixaban
Estonian
,
English
,
Latin
ATC code:
B01AF02
Dosage form:
film-coated tablet
Route of administration:
oral use
Strengh:
5mg
Amount in package:
100TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
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
Summary of product characteristics (SPC):
(last updated 15 September 2021)
Package information leaflet (PIL):
EST
(last updated 16 November 2021)
Labelling:
(last updated 15 September 2021)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Sandoz Pharmaceuticals d.d.
Marketing authorization number:
1037721
Marketing authorization issued on:
15 September 2021
Marketing authorization expires on:
15 September 2026
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: 14 September 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription