AG-DAPAGLIFLOZIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

DAPAGLIFLOZIN

Предлага се от:

ANGITA PHARMA INC.

АТС код:

A10BK01

INN (Международно Name):

DAPAGLIFLOZIN

дозиране:

5MG

Лекарствена форма:

TABLET

Композиция:

DAPAGLIFLOZIN 5MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Каталог на резюме:

Active ingredient group (AIG) number: 0156370001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2023-05-15

Данни за продукта

AG-Dapagliflozin (Dapagliflozin Tablets) - Product Monograph Page 1 of
81
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control Number: 269483
Date of
Initial Authorization:
NOV
28, 2022
AG-Dapagliflozin (Dapagliflozin Tablets) - Product Monograph Page 2 of
81
RECENT MAJOR LABEL CHANGES
None at time of authorization
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
...............................................................................................................................
5
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
....