AURO-DAPAGLIFLOZIN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DAPAGLIFLOZIN

Dostępny od:

AURO PHARMA INC

Kod ATC:

A10BK01

INN (International Nazwa):

DAPAGLIFLOZIN

Dawkowanie:

5MG

Forma farmaceutyczna:

TABLET

Skład:

DAPAGLIFLOZIN 5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2023-05-16

Charakterystyka produktu

AURO-DAPAGLIFLOZIN
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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
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RECENT MAJOR LABEL CHANGES
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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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TABLE OF CONTENTS
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PART I: HEALTH PROFESSIONAL INFORMATION
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1. INDICATIONS
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1.1 Pediatrics
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1.2 Geriatrics
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2. CONTRAINDICATIONS
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3. SERIOUS WARNINGS AND PRECAUTIONS BOX
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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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