NRA-APIXABAN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

APIXABAN

Предлага се от:

NORA PHARMA INC

АТС код:

B01AF02

INN (Международно Name):

APIXABAN

дозиране:

5MG

Лекарствена форма:

TABLET

Композиция:

APIXABAN 5MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2022-10-04

Данни за продукта

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