AURO-DAPAGLIFLOZIN / METFORMIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Available from:

AURO PHARMA 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:

7

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-05-16

Summary of Product characteristics

Auro-Dapagliflozin / Metformin Product Monograph
Page 1 of 81
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-DAPAGLIFLOZIN / METFORMIN
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE TABLETS
Tablets, 5 mg dapagliflozin and 850 mg metformin hydrochloride, 5 mg
dapagliflozin and 1000
mg metformin hydrochloride, Oral use
Combination of oral blood glucose lowering drugs
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Initial Authorization:
May 16, 2023
Date of Revision:
MAY 10, 2024
Submission Control Number: 282469
Auro-Dapagliflozin / Metformin Product Monograph
Page 2 of 81
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, Considerations for Special Populations
09 / 2023
4_DOSAGE_AND_ADMINISTRATION, 4.4_Administration
09 / 2023
7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery, Endocrine
and Metabolism, Hypothyroidism, Vitamin B
12
levels, Hepatic / Biliary /
Pancreatic, Monitoring and Laboratory Tests, Neurologic and Renal
09 / 2023
7_WARNINGS_AND_PRECAUTIONS, 7.1.4_Geriatrics
09 / 2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
05 / 2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
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4
1.1 Pediatrics
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