ELIQUIS TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

APIXABAN

Disponibil de la:

BRISTOL-MYERS SQUIBB CANADA

Codul ATC:

B01AF02

INN (nume internaţional):

APIXABAN

Dozare:

5MG

Forma farmaceutică:

TABLET

Compoziție:

APIXABAN 5MG

Calea de administrare:

ORAL

Unități în pachet:

10/60/180/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

Direct Factor Xa Inhibitors

Rezumat produs:

Active ingredient group (AIG) number: 0153051002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2012-12-05

Caracteristicilor produsului

_Pr_
_ELIQUIS (apixaban) Product Monograph _
_Page 1 of 83_
PRODUCT MONOGRAPH
Pr
ELIQUIS
®
apixaban tablets
2.5 mg and 5 mg
Anticoagulant
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Bristol-Myers Squibb Canada Co.
Montreal, Canada H4S 0A4
www.bmscanada.ca
Date of Initial Approval:
13 December 2011
Date of Revision:
07 October 2019
Registered trademark of Bristol-Myers Squibb Company used under
license by Bristol-Myers
Squibb Canada Co.
Submission Control No: 229267
_Pr_
_ELIQUIS (apixaban) Product Monograph _
_Page 2 of 83_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT
INFORMATION........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
26
OVERDOSAGE
................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 34
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
39
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 39
PART II: SCIENTIFIC INFORMATION
..............................................................................
41
PHARMACEUTICAL INFORMATION
.........................................................................
41
CLINICAL TRIALS
........................................................