MYLAN-MYCOPHENOLATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MYCOPHENOLATE MOFETIL

Available from:

MYLAN PHARMACEUTICALS ULC

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:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-01-09

Summary of Product characteristics

Page 1 of 65
PRODUCT MONOGRAPH
PR
MYLAN-MYCOPHENOLATE
Mycophenolate Mofetil Capsules, USP
250 mg
Mycophenolate Mofetil Tablets, USP
500 mg
Immunosuppressive Agent
Mylan Pharmaceuticals ULC
85 Advance Rd.,
Etobicoke, ON M8Z 2S6
Submission Control No: 194495
Date of Revision:
May 13, 2016
Page 2 of 65
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
.................................................................................................
4
WARNINGS AND PRECAUTIONS
.............................. ERROR! BOOKMARK NOT DEFINED.
ADVERSE REACTIONS
..................................................................................................
9
DRUG INTERACTIONS
................................................................................................
18
DOSAGE AND ADMINISTRATION
...........................................................................
23
OVERDOSAGE
...............................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 25
STORAGE AND STABILITY
.......................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
....................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 32
PART II: SCIENTIFIC INFORMATION .............................................................................
31
PHARMACEUTICAL INFORMATION
......................................................................
34
CLINICAL TRIALS
........................................................................................................
35
DETAILED PHARMACOLOGY
...