TEVA-LEFLUNOMIDE TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

LEFLUNOMIDE

Beschikbaar vanaf:

TEVA CANADA LIMITED

ATC-code:

L04AK01

INN (Algemene Internationale Benaming):

LEFLUNOMIDE

Dosering:

20MG

farmaceutische vorm:

TABLET

Samenstelling:

LEFLUNOMIDE 20MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30/100

Prescription-type:

Prescription

Therapeutisch gebied:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2004-12-10

Productkenmerken

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
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...........................................................................................................
4
1.1
Pediatrics
.............................................................................................................
4
1.2
Geriatrics
.............................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
4
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................... 5
4.4
Administration
....................................................................................................
6
4.5
Missed Dose
........................................................................................................
6
5
OVERDOSAGE
..........................................................................................................
6
6
DOSAGE FORMS, S