AG-DAPAGLIFLOZIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DAPAGLIFLOZIN

Tilgængelig fra:

ANGITA PHARMA INC.

ATC-kode:

A10BK01

INN (International Name):

DAPAGLIFLOZIN

Dosering:

5MG

Lægemiddelform:

TABLET

Sammensætning:

DAPAGLIFLOZIN 5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2023-05-15

Produktets egenskaber

AG-Dapagliflozin (Dapagliflozin Tablets) - Product Monograph Page 1 of
81
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control Number: 269483
Date of
Initial Authorization:
NOV
28, 2022
AG-Dapagliflozin (Dapagliflozin Tablets) - Product Monograph Page 2 of
81
RECENT MAJOR LABEL CHANGES
None at time of authorization
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
.........................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................
4
1
INDICATIONS
.........................................................................................................................
4
1.1
Pediatrics
...............................................................................................................................
4
1.2
Geriatrics
...............................................................................................................................
5
2
CONTRAINDICATIONS
....................................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................................
5
4
DOSAGE AND
ADMINISTRATION.....................................................................................................
5
4.1
Dosing Considerations
..........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....