NRA-APIXABAN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

APIXABAN

Beszerezhető a:

NORA PHARMA INC

ATC-kód:

B01AF02

INN (nemzetközi neve):

APIXABAN

Adagolás:

2.5MG

Gyógyszerészeti forma:

TABLET

Összetétel:

APIXABAN 2.5MG

Az alkalmazás módja:

ORAL

db csomag:

15G/50G

Recept típusa:

Prescription

Termék összefoglaló:

Active ingredient group (AIG) number: 0153051001; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2022-10-04

Termékjellemzők

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
..................................................................