NTP-LEFLUNOMIDE TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
11-10-2013
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ingredients actius:
LEFLUNOMIDE
Disponible des:
TEVA CANADA LIMITED
Codi ATC:
L04AK01
Designació comuna internacional (DCI):
LEFLUNOMIDE
Dosis:
10MG
formulario farmacéutico:
TABLET
Composición:
LEFLUNOMIDE 10MG
Vía de administración:
ORAL
Unidades en paquete:
30
tipo de receta:
Prescription
Área terapéutica:
DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0140182001; AHFS:
Estat d'Autorització:
CANCELLED PRE MARKET
Data d'autorització:
2015-08-06
Fitxa tècnica
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
.......................................................................
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