MAR-TERIFLUNOMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TERIFLUNOMIDE

Available from:

MARCAN PHARMACEUTICALS 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

Page 1 of 47
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MAR-TERIFLUNOMIDE
Teriflunomide tablets
Tablets, 14 mg, Oral
Immunomodulator Agent
Marcan Pharmaceuticals Inc.
2 Gurdwara Road Suite #112,
Ottawa, ON K2E 1A2
Date of Initial Authorization:
June 12, 2020
Date of Revision:
November 14, 2023
Submission Control No: 277980
Page 2 of 47 RECENT MAJOR LABEL CHANGES
1 Indications, 1.1 Pediatrics
04/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
04/2022
4 Dosage and Administration, 4.1 Dosing Considerations,
04/2022
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
04/2022
7 Warnings and Precautions, Cardiovascular
04/2022
7 Warnings and Precautions, Reproductive Health: Female and
Male Potential, Skin
04/2022
7 Warnings and Precautions, 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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................................
4
1.1
Pediatrics
............................................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................