CAPRELSA TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VANDETANIB

Available from:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

ATC code:

L01EX04

INN (International Name):

VANDETANIB

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

VANDETANIB 100MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0153066001; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-07-08

Summary of Product characteristics

_Pr_
_CAPRELSA_
_®_
_ (vandetanib) _
_ _
_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION PR
CAPRELSA
®
Vandetanib tablets
Tablets, 100 mg and 300 mg, Oral
Antineoplastic
Sanofi Genzyme, a division of sanofi-aventis
Canada Inc.
800-2700 Matheson Blvd East
Mississauga, ON L4W 4V9
Date of Initial Authorization:
JAN 12, 2012
Submission Control Number: 278499
Date of Revision:
DEC 20, 2023
_Pr_
_CAPRELSA_
_®_
_ (vandetanib) _
_ _
_Page 2 of 44_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Peri-Operative considerations
04/2022
7 Warnings and Precautions, Renal
04/2022
7 Warnings and Precautions, Reproductive Health: Female and
Male Potential
12/2023
7 Warnings and Precautions, Impaired Wound Healing
04/2022
7 Warnings and Precautions, 7.1.1 Pregnant Women
12/2023
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
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............