CO MYCOPHENOLATE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-10-2013
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Active ingredient:
MYCOPHENOLATE MOFETIL
Available from:
COBALT PHARMACEUTICALS COMPANY
ATC code:
L04AA06
INN (International Name):
MYCOPHENOLIC ACID
Dosage:
500MG
Pharmaceutical form:
TABLET
Composition:
MYCOPHENOLATE MOFETIL 500MG
Administration route:
ORAL
Units in package:
50/100
Prescription type:
Prescription
Therapeutic area:
IMMUNOSUPPRESSIVE AGENTS
Product summary:
Active ingredient group (AIG) number: 0128158002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-05-07
Summary of Product characteristics
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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
.............................................................................
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