APO-TERIFLUNOMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TERIFLUNOMIDE

Available from:

APOTEX 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

_APO-TERIFLUNOMIDE (Teriflunomide tablets) _
_ _
_ Page 1 of 51 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-TERIFLUNOMIDE
Teriflunomide tablets
Tablets, 14 mg, oral
Apotex Standard
Immunomodulator Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Initial Authorization:
MAY 16, 2022
Date of Revision:
JAN 04, 2024
Submission Control Number: 278671
_APO-TERIFLUNOMIDE (Teriflunomide tablets) _
_ _
_Page 2 of 51 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
02/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing
Considerations
02/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended
Dose and Dosage Adjustment
02/2023
7 WARNINGS AND PRECAUTIONS, Cardiovascular
02/2023
7 WARNINGS AND PRECAUTIONS,
Hepatic/Biliary/Pancreatic
01/2024
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
02/2023
7 WARNINGS AND PRECAUTIONS, Skin
02/2023
7 WARNINGS AND PRECAUTIONS, Respiratory
01/2024
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations,
7.1.3 Pediatric
01/2024
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
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
....................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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