M-TERIFLUNOMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TERIFLUNOMIDE

Available from:

MANTRA PHARMA INC

ATC code:

L04AK02

INN (International Name):

TERIFLUNOMIDE

Dosage:

14MG

Pharmaceutical form:

TABLET

Composition:

TERIFLUNOMIDE 14MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2022-05-16

Summary of Product characteristics

_M-TERIFLUNOMIDE (Teriflunomide tablets) Product Monograph_
_Page 1 of 48_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
M-TERIFLUNOMIDE
Teriflunomide tablets
tablets, 14 mg, oral
Immunomodulator Agent
Mantra Pharma Inc.
1000 rue Du Lux, Suite 201
Brossard, Quebec,
J4Y 0E3
Date of Initial Authorization:
December 24, 2021
Date of Revision:
November 29, 2023
Submission Control Number: 278238
_M-TERIFLUNOMIDE (Teriflunomide tablets) Product Monograph_
_Page 2 of 48_
RECENT MAJOR LABEL CHANGES
7 Warning and Precautions, 7.1 Special Populations, 7.1.1 Pregnant
Women
04/2022
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
11/2023
7 WARNINGS AND PRECAUTIONS, Respiratory
11/2023
7.1.3 WARNINGS AND PRECAUTIONS, Special Populations, Pediatric
11/2023
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
...................................................