NTP-LEFLUNOMIDE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

LEFLUNOMIDE

MAH:

TEVA CANADA LIMITED

ATC_code:

L04AK01

INN:

LEFLUNOMIDE

dosage:

20MG

pharmaceutical_form:

TABLET

composition:

LEFLUNOMIDE 20MG

administration_route:

ORAL

units_in_package:

30

prescription_type:

Prescription

therapeutic_area:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

leaflet_short:

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

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2015-08-06

SPC

PRODUCT MONOGRAPH
Pr
NTP-LEFLUNOMIDE
(Leflunomide)
10 mg and 20 mg Tablets
Antirheumatic Agent
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No.: 167474
Date of Preparation:
October 11, 2013
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
...............................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
..............................................................................................
13
DRUG INTERACTIONS
..............................................................................................
17
DOSAGE AND ADMINISTRATION
..........................................................................
21
OVERDOSAGE
............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 22
STORAGE AND STABILITY
......................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 25
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
......................................................................
27
CLINICAL TRIALS
......................................................................................................
28
DETAILED PHARMACOLOGY
.................................................................................
35
TOXICOLOGY
.......................................................................