M-DAPAGLIFLOZIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DAPAGLIFLOZIN

Available from:

MANTRA PHARMA INC

ATC code:

A10BK01

INN (International Name):

DAPAGLIFLOZIN

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

DAPAGLIFLOZIN 5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-05-16

Summary of Product characteristics

_ _
_M-DAPAGLIFLOZIN (dapagliflozin) _
_Page 1 of 79 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
M-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Mantra Pharma Inc.
1000 Du Lux, Suite 201
Brossard, Quebec
J4Y 0E3
Date of
Initial Authorization:
February 8, 2023
Date of revision:
December 20, 2023
Submission Control Number: 276505
_ _
_M-DAPAGLIFLOZIN (dapagliflozin) _
_Page 2 of 79 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
12/2023
2 CONTRAINDICATIONS
12/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dosage Adjustment
12/2023
7 WARNINGS AND PRECAUTIONS
12/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
12/2023
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
..................................................................