AURO-DAPAGLIFLOZIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DAPAGLIFLOZIN

Tilgængelig fra:

AURO PHARMA INC

ATC-kode:

A10BK01

INN (International Name):

DAPAGLIFLOZIN

Dosering:

10MG

Lægemiddelform:

TABLET

Sammensætning:

DAPAGLIFLOZIN 10MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2023-05-16

Produktets egenskaber

AURO-DAPAGLIFLOZIN
Page 1 of 71
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
ATC Code: A10BK01
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Initial Authorization:
September 26, 2022
Submission Control Number: 260267
AURO-DAPAGLIFLOZIN
Page 2 of 71
RECENT MAJOR LABEL CHANGES
NA
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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4
1.2 Geriatrics
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4
2. CONTRAINDICATIONS
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5
3. SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4. DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
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5
4.2 Recommended Dose and Dosage Adjustment
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