NRA-APIXABAN TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

APIXABAN

Dostupné s:

NORA PHARMA INC

ATC kód:

B01AF02

INN (Mezinárodní Name):

APIXABAN

Dávkování:

5MG

Léková forma:

TABLET

Složení:

APIXABAN 5MG

Podání:

ORAL

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2022-10-04

Charakteristika produktu

PRODUCT MONOGRAPH
PR
NRA-APIXABAN
Apixaban Tablets
2.5 mg and 5 mg
Anticoagulant
Nora Pharma Inc.
1565 boul. Lionel-Boulet
Varennes, QC, J3X 1P7
Canada
Date of Initial Approval:
MAR 21, 2022
Date of Revision:
OCT 4, 2022
Submission Control No: 268199
_Pr_
_NRA-APIXABAN Product Monograph Page 2 of 77 _
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
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
24
OVERDOSAGE
.......................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 32
STORAGE AND STABILITY
.................................................................................................
37
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 37
PART II: SCIENTIFIC INFORMATION
....................................................................................
38
PHARMACEUTICAL INFORMATION
..................................................................