SANDOZ MYCOPHENOLATE MOFETIL TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

MYCOPHENOLATE MOFETIL

Beschikbaar vanaf:

SANDOZ CANADA INCORPORATED

ATC-code:

L04AA06

INN (Algemene Internationale Benaming):

MYCOPHENOLIC ACID

Dosering:

500MG

farmaceutische vorm:

TABLET

Samenstelling:

MYCOPHENOLATE MOFETIL 500MG

Toedieningsweg:

ORAL

Eenheden in pakket:

50/100

Prescription-type:

Prescription

Therapeutisch gebied:

IMMUNOSUPPRESSIVE AGENTS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2012-02-02

Productkenmerken

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_Sandoz Mycophenolate Mofetil _
_Page 1 of 68_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ MYCOPHENOLATE MOFETIL
Mycophenolate Mofetil
Capsules, 250 mg, oral
Tablets, 500 mg, oral
Manufacturer’s Standard
Immunosuppressive Agent
Sandoz Canada Inc.
Date of Initial Authorization:
110 Rue de Lauzon
November 30, 2011
Boucherville, QC, Canada
Date of Revision:
J4B 1E6
January 27, 2022
Submission Control No: 256173
_ _
_Sandoz Mycophenolate Mofetil _
_Page 2 of 68_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Immune
01/2022
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
................................................................ 5
4.4
Administration........