VFEND POWDER FOR SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VORICONAZOLE

Available from:

PFIZER CANADA ULC

ATC code:

J02AC03

INN (International Name):

VORICONAZOLE

Dosage:

200MG

Pharmaceutical form:

POWDER FOR SUSPENSION

Composition:

VORICONAZOLE 200MG

Administration route:

ORAL

Units in package:

40MG/ML

Prescription type:

Prescription

Therapeutic area:

AZOLES

Product summary:

Active ingredient group (AIG) number: 0150242003; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-05-15

Summary of Product characteristics

_Product Monograph _
_ _
_VFEND (voriconazole) _
_Page 1 of 73_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VFEND
®
Voriconazole
Tablets 50 mg and 200 mg, Oral
200 mg / Vial (10 mg/mL when reconstituted) for Injection
Powder for Oral Suspension 3 g / Bottle (40 mg/mL when reconstituted)
Antifungal Agent
Pfizer Canada ULC
17300 Trans Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
AUG 20, 2004
Date of Revision:
JUL 05, 2023
Submission Control Number: 272725
Registered trademark Pfizer Products Inc.
Pfizer Canada ULC., licensee
© Pfizer Canada ULC, 2023
_ _
_Product Monograph _
_ _
_VFEND (voriconazole) _
_Page 2 of 73_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
07/2023
7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis
11/2022
7 WARNINGS AND PRECAUTIONS, Tyrosine kinase inhibitors (CYP3A4
substrates)
11/2022
2 CONTRAINDICATIONS
02/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 6
4
DOSAGE AND ADMINISTRATION
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