AG-URSODIOL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

URSODIOL

Available from:

ANGITA PHARMA INC.

ATC code:

A05AA02

INN (International Name):

URSODEOXYCHOLIC ACID

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

URSODIOL 500MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

CHOLELITHOLYTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0122789002; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-09-23

Summary of Product characteristics

AG-Ursodiol (Ursodiol Tablets)
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Page 1 of 32
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-URSODIOL
Ursodiol Tablets
Tablets, 250 mg & 500 mg, Oral
USP
Bile Acid Preparation
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
September 23, 2020
Date of Revision:
September 26, 2023
Submission Control Number: 278847
AG-Ursodiol (Ursodiol Tablets)
_ _
Page 2 of 32
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
09/2023
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
.............................................................................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
4
4
DOSAGE AND ADMINISTRATION
...............................................................................
4
4.1
Dosing Considerations
........................................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
................................................................... 5
4.3
Administration
....................................................................................................................
5
4.4
Missed Dose
.....................