Product class:
|
Medicinal product with marketing authorization
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Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
ABATIXENT
|
Active substances:
|
|
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 September 15, 2021)
|
Package information leaflet (PIL):
|
EST (last updated November 16, 2021)
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Labelling:
|
(last updated September 15, 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:
|
Sandoz Pharmaceuticals d.d.
|
Marketing authorization number:
|
1037721
|
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
|
PƤritolumaa
|
Additional information
|
1804845
|
ABATIXENT
|
film-coated tablet
|
5mg 10TK
|
Prescription
|
|
|
|
|
|
1804856
|
ABATIXENT
|
film-coated tablet
|
5mg 12TK
|
Prescription
|
|
|
|
|
|
1804867
|
ABATIXENT
|
film-coated tablet
|
5mg 14TK
|
Prescription
|
|
|
|
|
|
1804878
|
ABATIXENT
|
film-coated tablet
|
5mg 20TK
|
Prescription
|
|
|
|
|
|
1804889
|
ABATIXENT
|
film-coated tablet
|
5mg 28TK
|
Prescription
|
|
|
|
|
|
1804890
|
ABATIXENT
|
film-coated tablet
|
5mg 30TK
|
Prescription
|
|
|
|
|
|
1804902
|
ABATIXENT
|
film-coated tablet
|
5mg 56TK
|
Prescription
|
|
|
|
|
|
1804913
|
ABATIXENT
|
film-coated tablet
|
5mg 60TK
|
Prescription
|
|
|
|
|
|
1804924
|
ABATIXENT
|
film-coated tablet
|
5mg 100TK
|
Prescription
|
|
|
|
|
|
1804935
|
ABATIXENT
|
film-coated tablet
|
5mg 168TK
|
Prescription
|
|
|
|
|
|
1804946
|
ABATIXENT
|
film-coated tablet
|
5mg 180TK
|
Prescription
|
|
|
|
|
|
1804957
|
ABATIXENT
|
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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