APO-LEFLUNOMIDE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LEFLUNOMIDE

Available from:

APOTEX INC

ATC code:

L04AK01

INN (International Name):

LEFLUNOMIDE

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

LEFLUNOMIDE 10MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0140182001; AHFS:

Authorization status:

APPROVED

Authorization date:

2004-09-08

Summary of Product characteristics

_APO-LEFLUNOMIDE (Leflunomide Tablets) _
_ _
_ Page 1 of 73 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LEFLUNOMIDE
Leflunomide Tablets
Tablets, 10 mg and 20 mg, Oral
Apotex Standard
Antirheumatic, Immunomodulator Agent
ATC Code: L04AA13
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
September 8, 2004
Date of Revision:
July 24, 2023
Submission Control Number: 272007
_APO-LEFLUNOMIDE (Leflunomide Tablets) _
_ _
_Page 2 of 73 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
07/2023
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