CO MYCOPHENOLATE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

MYCOPHENOLATE MOFETIL

Disponible desde:

COBALT PHARMACEUTICALS COMPANY

Código ATC:

L04AA06

Designación común internacional (DCI):

MYCOPHENOLIC ACID

Dosis:

500MG

formulario farmacéutico:

TABLET

Composición:

MYCOPHENOLATE MOFETIL 500MG

Vía de administración:

ORAL

Unidades en paquete:

50/100

tipo de receta:

Prescription

Área terapéutica:

IMMUNOSUPPRESSIVE AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0128158002; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2018-05-07

Ficha técnica

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_Page 1 of 55_
PRODUCT MONOGRAPH
PR
_CO_ MYCOPHENOLATE
Mycophenolate Mofetil Tablets USP
500 mg
Immunosuppressive Agent
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
SUBMISSION CONTROL NO: 168316
Date of Revision:
October 16, 2013
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_Page 2 of 55_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
......................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 27
PART II: SCIENTIFIC INFORMATION
..............................................................................
28
PHARMACEUTICAL INFORMATION
.........................................................................
28
CLINICAL TRIALS
.........................................................................................................
29
DETAILED PHARMACOLOGY
.............................................................................