ZELBORAF TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VEMURAFENIB

Available from:

HOFFMANN-LA ROCHE LIMITED

ATC code:

L01EC01

INN (International Name):

VEMURAFENIB

Dosage:

240MG

Pharmaceutical form:

TABLET

Composition:

VEMURAFENIB 240MG

Administration route:

ORAL

Units in package:

56

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0153092001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-02-15

Summary of Product characteristics

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_Page 1 of 43_
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PRODUCT MONOGRAPH
Pr
ZELBORAF
®
vemurafenib
Film-coated tablet, 240 mg
Professed Standard
Protein Kinase Inhibitor
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario, Canada
L5N 5M8
Date of Revision:
December 10, 2019
www.rochecanada.com
Submission Control No: 231572
ZELBORAF
®
is a registered trade-mark of F. Hoffmann-La Roche AG, used under
license.
Manufactured under license from Plexxikon Inc., a member of the
Daiichi Sankyo group.
©
Copyright 2012-2019, Hoffmann-La Roche Limited
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_Page 2 of 43 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
..............................................................................................
11
DRUG INTERACTIONS
..............................................................................................
19
DOSAGE AND ADMINISTRATION
...........................................................................
22
OVERDOSAGE
............................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 25
STORAGE AND STABILITY
.....................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
....................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 27
PART II: SCIENTIFIC INFORMATION
....................................................