AG-DAPAGLIFLOZIN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DAPAGLIFLOZIN

제공처:

ANGITA PHARMA INC.

ATC 코드:

A10BK01

INN (국제 이름):

DAPAGLIFLOZIN

복용량:

5MG

약제 형태:

TABLET

구성:

DAPAGLIFLOZIN 5MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2023-05-15

제품 특성 요약

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
....