RIVA-DAPAGLIFLOZIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

DAPAGLIFLOZIN

Предлага се от:

LABORATOIRE RIVA INC.

АТС код:

A10BK01

INN (Международно Name):

DAPAGLIFLOZIN

дозиране:

10MG

Лекарствена форма:

TABLET

Композиция:

DAPAGLIFLOZIN 10MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Каталог на резюме:

Active ingredient group (AIG) number: 0156370002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2023-05-15

Данни за продукта

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_RIVA-DAPAGLIFLOZIN (dapagliflozin) _
_Page 1 of 72 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
RIVA-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Date of Initial Authorization:
July 11, 2022
Submission Control Number: 254745
_ _
_RIVA-DAPAGLIFLOZIN (dapagliflozin) _
_Page 2 of 72 _
RECENT MAJOR LABEL CHANGES
Not applicable
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4.5
Missed Dose
.....................................................................................