FORXIGA TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE)

Dostupno od:

ASTRAZENECA CANADA INC

ATC koda:

A10BK01

INN (International ime):

DAPAGLIFLOZIN

Doziranje:

10MG

Farmaceutski oblik:

TABLET

Sastav:

DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) 10MG

Administracija rute:

ORAL

Jedinice u paketu:

30

Tip recepta:

Prescription

Područje terapije:

Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2014-12-12

Svojstava lijeka

FORXIGA (dapagliflozin propanediol monohydrate)
Page 1 of 80
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
FORXIGA
®
Dapagliflozin propanediol monohydrate
Tablets, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
Dec 10, 2014
Date of Revision:
Oct 10, 2023
Submission Control Number: 268982
FORXIGA
®
is a registered trademark of AstraZeneca AB, used under license by
AstraZeneca Canada Inc.
FORXIGA (dapagliflozin propanediol monohydrate)
Page 2 of 80
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
10/2023
2 CONTRAINDICATIONS
08/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
08/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
10/2023
7 WARNINGS AND PRECAUTIONS
08/2021
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
10/2023
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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5
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX