APO-DAPAGLIFLOZIN-METFORMIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Available from:

APOTEX INC

ATC code:

A10BD15

INN (International Name):

METFORMIN AND DAPAGLIFLOZIN

Dosage:

5MG; 850MG

Pharmaceutical form:

TABLET

Composition:

DAPAGLIFLOZIN 5MG; METFORMIN HYDROCHLORIDE 850MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0257650001; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-05-16

Summary of Product characteristics

_APO-DAPAGLIFLOZIN-METFORMIN (dapagliflozin and metformin
hydrochloride tablets) _
_Page 1 of 85 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DAPAGLIFLOZIN-METFORMIN
Dapagliflozin and Metformin Hydrochloride tablets
Tablets, 5 mg dapagliflozin / 850 mg metformin hydrochloride,
5 mg dapagliflozin / 1000 mg metformin hydrochloride,
for oral use
Combination of oral blood glucose lowering drugs
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 16, 2023
Date of Revision:
SEP 19, 2023
Submission Control Number: 275438
_APO-DAPAGLIFLOZIN-METFORMIN (dapagliflozin and metformin
hydrochloride tablets) _
_Page 2 of 85 _
RECENT MAJOR LABEL CHANGES
1. INDICATIONS. 1.2 Geriatrics
09/2023
2 CONTRAINDICATIONS
09/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
09/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
09/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
09/2023
7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery
09/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
09/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
09/2023
7 WARNINGS AND PRECAUTIONS,
Hepatic/Biliary/Pancreatic
09/2023
7 WARNINGS AND PRECAUTIONS,
Monitoring and Laboratory Tests
09/2023
7 WARNINGS AND PRECAUTIONS,
Neurologic
09/2023
7 WARNINGS AND PRECAUTIONS,
Renal
09/2023
7.1.4 Geriatrics
09/2023
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
.....................................................................
5
1
INDICATIONS
................................................................................................................
5
1.1
Pediatrics
....................................