AG-DAPAGLIFLOZIN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DAPAGLIFLOZIN

Διαθέσιμο από:

ANGITA PHARMA INC.

Φαρμακολογική κατηγορία (ATC):

A10BK01

INN (Διεθνής Όνομα):

DAPAGLIFLOZIN

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

DAPAGLIFLOZIN 5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2023-05-15

Αρχείο Π.Χ.Π.

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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................
4
1
INDICATIONS
.........................................................................................................................
4
1.1
Pediatrics
...............................................................................................................................
4
1.2
Geriatrics
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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
....