ACCEL-MYCOPHENOLATE MOFETIL TABLETS

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

MYCOPHENOLATE MOFETIL

Disponible desde:

ACCEL PHARMA INC

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

tipo de receta:

Prescription

Área terapéutica:

IMMUNOSUPPRESSIVE AGENTS

Resumen del producto:

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

Estado de Autorización:

CANCELLED PRE MARKET

Fecha de autorización:

2017-05-19

Ficha técnica

PRODUCT MONOGRAPH
Pr
ACCEL-MYCOPHENOLATE MOFETIL TABLETS
Mycophenolate mofetil
Film Coated Tablets – 500 mg
USP
Immunosuppressive Agent
Accel Pharma Inc.
99 Place Frontenac
Pointe-Claire, QC, H9R 4Z7
Canada
Date of Preparation:
January 24, 2013
Submission Control No: 161625
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_Accel-Mycophenolate Mofetil Tablets _
_Page 2 of 57_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
.......................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................26
PART II: SCIENTIFIC INFORMATION
...............................................................................27
PHARMACEUTICAL INFORMATION
..........................................................................27
CLINICAL TRIALS
................................................