ACCEL-MYCOPHENOLATE MOFETIL CAPSULES

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:

250MG

formulario farmacéutico:

CAPSULE

Composición:

MYCOPHENOLATE MOFETIL 250MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

IMMUNOSUPPRESSIVE AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0128158001; AHFS:

Estado de Autorización:

CANCELLED PRE MARKET

Fecha de autorización:

2017-05-19

Ficha técnica

PRODUCT MONOGRAPH
Pr
ACCEL-MYCOPHENOLATE MOFETIL CAPSULES
Mycophenolate mofetil
Capsules – 250 mg
Pharmaceutical standard house
Immunosuppressive Agent
Accel Pharma Inc.
99 Place Frontenac
Pointe-Claire, QC, H9R 4Z7
Canada
Date of Preparation:
January 28, 2013
Submission Control No: 161660
_ _
_Accel-Mycophenolate Mofetil Capsules _
_Page 2 of 58_
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
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................26
SPECIAL HANDLING INSTRUCTIONS
.......................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
...............................................................................28
PHARMACEUTICAL INFORMATION
..........................................................................28
CLINICAL TRIALS
...............................