|
Product class:
|
Authorized package
|
|
Medicinal product class:
|
For human use
|
|
Package code:
|
1804733
|
|
Name of medicinal product:
|
ABATIXENT
|
|
Active substances:
|
|
|
ATC code:
|
B01AF02
|
|
Dosage form:
|
film-coated tablet
|
|
Route of administration:
|
oral use
|
|
Strengh:
|
2,5mg
|
|
Amount in package:
|
12TK
|
|
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:
November 16, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere