ERIVEDGE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-05-2020
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Active ingredient:
VISMODEGIB
Available from:
HOFFMANN-LA ROCHE LIMITED
ATC code:
L01XJ01
INN (International Name):
VISMODEGIB
Dosage:
150MG
Pharmaceutical form:
CAPSULE
Composition:
VISMODEGIB 150MG
Administration route:
ORAL
Units in package:
28
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0154490001; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-07-12
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
ERIVEDGE
®
vismodegib
Capsule, 150 mg
Antineoplastic agent
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario L5N 5M8
Date of Initial Approval:
July 10, 2013
Date of Revision:
May 11, 2020
www.rochecanada.com
Submission Control No: 236154
ERIVEDGE
®
is a registered trade-mark of F. Hoffmann-La Roche AG, used under
license
©
Copyright 2013-2020, Hoffmann-La Roche Limited
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
18
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
......................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL INFORMATION
..............................................................
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