APO-ERLOTINIB TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Available from:

APOTEX INC

ATC code:

L01EB02

INN (International Name):

ERLOTINIB

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0151203002; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-03-09

Summary of Product characteristics

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PRODUCT MONOGRAPH
Pr
APO-ERLOTINIB
Erlotinib Hydrochloride tablets
Erlotinib, 25 mg, 100 mg, 150 mg
Protein Kinase Inhibitor (L01XE03)
Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada, M9L 1T9
Date of Revision:
December 5, 2018
SUBMISSION CONTROL NO: 221870
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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
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 19
STORAGE AND STABILITY
.................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
........................