NAT-ERLOTINIB TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
15-07-2020
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Active ingredient:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE)
Available from:
NATCO PHARMA (CANADA) INC
ATC code:
L01EB02
INN (International Name):
ERLOTINIB
Dosage:
150MG
Pharmaceutical form:
TABLET
Composition:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0151203003; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-12-14
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
NAT-ERLOTINIB
Erlotinib hydrochloride tablets
25 mg, 100 mg and 150 mg
erlotinib
Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor
Protein Kinase Inhibitor (L01XE03)
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1,
Suite 200
Mississauga, Ontario, Canada
L5N 1P7
Date of Revision:
July15, 2020
SUBMISSION CONTROL NO: 238581
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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
.................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 20
STORAGE AND STABILITY
..........................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
........................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
..........................................................................
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