APO-MYCOPHENOLIC ACID TABLET (ENTERIC-COATED)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)

Available from:

APOTEX INC

ATC code:

L04AA06

INN (International Name):

MYCOPHENOLIC ACID

Dosage:

180MG

Pharmaceutical form:

TABLET (ENTERIC-COATED)

Composition:

MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM) 180MG

Administration route:

ORAL

Units in package:

120

Prescription type:

Prescription

Therapeutic area:

IMMUNOSUPPRESSIVE AGENTS

Product summary:

Active ingredient group (AIG) number: 0150521001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-05-06

Summary of Product characteristics

_Pr_
_APO-MYCOPHENOLIC ACID (_Mycophenolic acid delayed-release tablets) _
Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-MYCOPHENOLIC ACID
Mycophenolic acid delayed-release tablets
Delayed-release tablets, 180 mg and 360 mg mycophenolic acid (as
mycophenolate sodium), Oral
USP
Immunosuppressant
ATC code: L04AA06
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 06, 2014
Date of Revision:
NOV 10, 2022
Submission Control Number: 264756
_Pr_
_APO-MYCOPHENOLIC ACID (_Mycophenolic acid delayed-release tablets) _
Page 2 of 43 _
RECENT MAJOR LABEL CHANGES
None at the time of authorisation
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
.........................................................................................................
4
1.2
Geriatrics..........................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................... 4
4
DOSAGE AND
ADMINISTRATION....................................................................................
5
4.1
Dosing Considerations
......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.................................