APO-ERLOTINIB TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Boleh didapati daripada:

APOTEX INC

Kod ATC:

L01EB02

INN (Nama Antarabangsa):

ERLOTINIB

Dos:

150MG

Borang farmaseutikal:

TABLET

Komposisi:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0151203003; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2017-03-09

Ciri produk

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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
........................