TYSABRI SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NATALIZUMAB

Available from:

BIOGEN CANADA INC

ATC code:

L04AG03

INN (International Name):

NATALIZUMAB

Dosage:

300MG

Pharmaceutical form:

SOLUTION

Composition:

NATALIZUMAB 300MG

Administration route:

INTRAVENOUS

Units in package:

1VIAL

Prescription type:

Prescription

Therapeutic area:

Immunomodulatory Agents

Product summary:

Active ingredient group (AIG) number: 0151674001; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-09-28

Summary of Product characteristics

_TYSABRI natalizumab for injection _
_Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TYSABRI
TM
Natalizumab for injection
Concentrate for solution for intravenous infusion
300 mg/15 mL
Selective adhesion molecule inhibitor
Biogen Canada Inc.
3250 Bloor Street West, Suite 1200
East Tower
Toronto, ON M8X 2X9
Date of Initial Authorization:
SEP 28, 2006
Date of Revision:
AUG 21, 2023
Submission Control Number:
267755
© Biogen 2006. All rights reserved.
_TYSABRI natalizumab for injection _
_Page 2 of 50_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.4 Administration
7 Warnings and Precautions
7 Warnings and Precautions, 7.1.1 Pregnant Women
08/2023
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
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adju