AG-DAPAGLIFLOZIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DAPAGLIFLOZIN

Available from:

ANGITA PHARMA INC.

ATC code:

A10BK01

INN (International Name):

DAPAGLIFLOZIN

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

DAPAGLIFLOZIN 10MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-05-15

Summary of Product characteristics

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
....