NTP-LEFLUNOMIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-10-2013
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
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
Prescription type:
Prescription
Therapeutic area:
DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0140182002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2015-08-06
Summary of Product characteristics
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
.......................................................................
Read the complete document
