ACH-TERIFLUNOMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TERIFLUNOMIDE

Available from:

ACCORD HEALTHCARE 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

_ACH-TERIFLUNOMIDE Teriflunomide tablets _
_Page 1 of 45 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ACH-TERIFLUNOMIDE
Teriflunomide tablets
Tablets, 14 mg, Oral
Immunomodulator Agent
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Initial Authorization:
May 16, 2022
Date of Revision:
November 10, 2023
Submission Control Number: 277441
_ACH-TERIFLUNOMIDE Teriflunomide tablets _
_Page 2 of 45 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
05/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
05/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular
05/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
05/2022
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
11/2023
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
05/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
05/2022
7 WARNINGS AND PRECAUTIONS, Skin
05/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant
Women
05/2022
7 WARNINGS AND PRECAUTIONS, Respiratory
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1. Special Populations, 7.1.3 Pediatric
11/2023
8 ADVERSE REACTIONS, 8.2 Clinical Trial Adverse Reactions, Pediatric
Population
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
.......................................................................
3
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
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