TEVA-LEFLUNOMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LEFLUNOMIDE

Available from:

TEVA CANADA LIMITED

ATC code:

L04AK01

INN (International Name):

LEFLUNOMIDE

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

LEFLUNOMIDE 20MG

Administration route:

ORAL

Units in package:

30/100

Prescription type:

Prescription

Therapeutic area:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0140182002; AHFS:

Authorization status:

APPROVED

Authorization date:

2004-12-10

Summary of Product characteristics

TEVA-LEFLUNOMIDE
Page 1 of 77
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR TEVA-LEFLUNOMIDE
Leflunomide Tablets
Film-coated tablets, 10 mg and 20 mg, Oral
Teva Standard
Antirheumatic, Immunomodulator Agent
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
December 10, 2004
Toronto, ON
M1B 2K9
Date of Revision:
Canada June 5, 2023
www.tevacanada.com
Submission Control Number: 270353
2
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
05/2023
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
...........................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.2
Recommended Dose and Dosage Adjustment
................................................... 5
4.4
Administration
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6
4.5
Missed Dose
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6
5
OVERDOSAGE
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6
6
DOSAGE FORMS, S