TEVA-ERLOTINIB TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-01-2019
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Active ingredient:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE)
Available from:
TEVA CANADA LIMITED
ATC code:
L01EB02
INN (International Name):
ERLOTINIB
Dosage:
25MG
Pharmaceutical form:
TABLET
Composition:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 25MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0151203001; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-12-08
Summary of Product characteristics
1
PRODUCT MONOGRAPH
PR
TEVA-ERLOTINIB
Erlotinib Hydrochloride Tablets
25 mg, 100 mg, 150 mg Erlotinib
Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor
Protein Kinase Inhibitor (L01XE03)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control No. 223095
Date of Revision:
January 16, 2019
2
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
.........................................................................................................
9
DRUG
INTERACTIONS
.......................................................................................................
16
DOSAGE
AND
ADMINISTRATION
...................................................................................
18
OVERDOSAGE
......................................................................................................................
19
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................ 20
STORAGE
AND
STABILITY
...............................................................................................
22
SPECIAL
HANDLING
INSTRUCTIONS
...........................................................................
22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
................................................ 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL
INFORMATION
.........................................................
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