AURO-DAPAGLIFLOZIN / METFORMIN TABLET

Country: Canada

Language: English

Source: Health Canada

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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:

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

                                _Auro-Dapagliflozin / Metformin Product Monograph _
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Page 1 of 70
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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
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:
September 1, 2023
Submission Control Number: 275247
_Auro-Dapagliflozin / Metformin Product Monograph _
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Page 2 of 70
_ _
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 B12 levels,
Hepatic/Biliary/Pancreatic, Monitoring and Laboratory Tests,
Neurologic and
Renal
09/2023
7_WARNINGS_AND_PRECAUTIONS, 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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 4
1
INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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