AUBAGIO TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TERIFLUNOMIDE

Available from:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

ATC code:

L04AK02

INN (International Name):

TERIFLUNOMIDE

Dosage:

14MG

Pharmaceutical form:

TABLET

Composition:

TERIFLUNOMIDE 14MG

Administration route:

ORAL

Units in package:

28

Prescription type:

Prescription

Therapeutic area:

Immunomodulatory Agents

Product summary:

Active ingredient group (AIG) number: 0154970001; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-11-14

Summary of Product characteristics

_AUBAGIO (Teriflunomide tablets) _
_Page 1 of 45 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AUBAGIO
®
Teriflunomide
tablets
14 mg
Immunomodulator Agent
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
2700 Matheson Blvd East
Mississauga, ON L4W 4V9
Date of Initial Authorization:
November 7, 2013
Date of Revision:
June 23, 2023
Submission Control No: 270681
_ _
_AUBAGIO (Teriflunomide tablets) _
_ _
_Page 2 of 45_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
06/2023
7 WARNINGS AND PRECAUTIONS, Respiratory
7.1.3 WARNINGS AND PRECAUTIONS, Special Populations, Pediatric
06/2023
06/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................5
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment....................................