PHL-LEFLUNOMIDE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-06-2016
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:
PHARMEL 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:
CANCELLED POST MARKET
Authorization date:
2008-10-31
Summary of Product characteristics
PRODUCT MONOGRAPH
PR PHL-LEFLUNOMIDE
Leflunomide Tablets, House Standard
10 mg and 20 mg
Antirheumatic, Immunomodulator Agent
PHARMEL INC.
6111 Royalmount Avenue, Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
June 22, 2016
Submission Control No.: 195001
_phl-LEFLUNOMIDE Product Monograph _
_Page 2 of 69_
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
.........................................................................................14
DRUG INTERACTIONS
.........................................................................................19
DOSAGE AND ADMINISTRATION
.....................................................................23
OVERDOSAGE
.......................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
...................................................25
STORAGE AND STABILITY
.................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................28
PART II: SCIENTIFIC INFORMATION
................................................................................29
PHARMACEUTICAL INFORMATION
.................................................................29
CLINICAL TRIALS
.................................................................................................30
DETAILED PHARMACOLOGY
............................................................................38
TOXICOLOGY
...................................................................
Read the complete document
