NU-LEFLUNOMIDE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
02-02-2012
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Werkstoffen:
LEFLUNOMIDE
Beschikbaar vanaf:
NU-PHARM INC
ATC-code:
L04AK01
INN (Algemene Internationale Benaming):
LEFLUNOMIDE
Dosering:
20MG
farmaceutische vorm:
TABLET
Samenstelling:
LEFLUNOMIDE 20MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Therapeutisch gebied:
DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0140182002; AHFS:
Autorisatie-status:
CANCELLED (UNRETURNED ANNUAL)
Autorisatie datum:
2018-03-28
Productkenmerken
Page 1 of 62
PRODUCT MONOGRAPH
Pr
NU-LEFLUNOMIDE
LEFLUNOMIDE TABLETS
HOUSE STANDARD
10 MG AND 20 MG
ANTIRHEUMATIC, IMMUNOMODULATOR AGENT
NU-PHARM INC.
DATE OF REVISION:
1165 CREDITSTONE ROAD, UNIT 2
FEBRUARY 2, 2012
VAUGHAN, ONTARIO
L4K 4N7
CONTROL #: 152701
Page 2 of 62
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.....................................................................................................................18
DOSAGE AND
ADMINISTRATION.................................................................................................21
OVERDOSAGE
...................................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................23
STORAGE AND
STABILITY.............................................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................26
PART II: SCIENTIFIC INFORMATION
...........................................................................................27
PHARMACEUTICAL
INFORMATION....................................................................................
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