TEVA-TERIFLUNOMIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-01-2024
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Active ingredient:
TERIFLUNOMIDE
Available from:
TEVA CANADA LIMITED
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
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_Teva-Teriflunomide (teriflunomide) Page 1 of 51_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-TERIFLUNOMIDE
Teriflunomide tablets
Tablets, 14 mg, Oral
Immunomodulator Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Authorization:
JUN 26, 2020
Date of Revision:
JAN 25, 2024
Submission Control Number: 279068
_Teva-Teriflunomide (teriflunomide) Page 2 of 51_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
01/2024
7 WARNINGS AND PRECAUTIONS, Respiratory
01/2024
7.1.3 WARNINGS AND PRECAUTIONS, Special Populations, 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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4 DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
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5
4.2 Recommended Dose and Dosage Adjustm
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