VIMIZIM SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ELOSULFASE ALFA

Available from:

BIOMARIN INTERNATIONAL LIMITED

ATC code:

A16AB12

INN (International Name):

ELOSULFASE ALFA

Dosage:

1MG

Pharmaceutical form:

SOLUTION

Composition:

ELOSULFASE ALFA 1MG

Administration route:

INTRAVENOUS

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

ENZYMES

Product summary:

Active ingredient group (AIG) number: 0155870001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-07-02

Summary of Product characteristics

_Vimizim (elosulfase alfa) Product Monograph _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VIMIZIM
®
(elosulfase alfa)
Solution for Intravenous Infusion
5 mg/5 mL (1 mg/mL)
Enzyme Replacement Therapy
ATC Code: A16AB12
BioMarin International Limited
Shanbally, Ringaskiddy
County Cork, Ireland
www.bmrn.com
DISTRIBUTOR:
BioMarin Pharmaceutical (Canada) Inc.
Toronto, ON
Canada M5H 3C2
www.bmrn.com
Submission Control No: 194707
Date of Approval: July 14, 2016
_Vimizim (elosulfase alfa) Product Monograph _
_Page 2 of 29_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................17
SPECIAL HANDLING INSTRUCTIONS
.......................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
.........................