PMS-ERLOTINIB TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Disponible desde:

PHARMASCIENCE INC

Código ATC:

L01EB02

Designación común internacional (DCI):

ERLOTINIB

Dosis:

100MG

formulario farmacéutico:

TABLET

Composición:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100MG

Vía de administración:

ORAL

Unidades en paquete:

30/100

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2016-05-02

Ficha técnica

PRODUCT MONOGRAPH
Pr
PMS-ERLOTINIB
Erlotinib Hydrochloride Tablets
100 mg and 150 mg erlotinib
EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) TYROSINE KINASE
INHIBITOR
PROTEIN KINASE INHIBITOR (L01XE03)
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF REVISION
:
November 27, 2018
Submission Control No: 221860
_ _
_pms-ERLOTINIB Product Monograph _
_Page 2 of 45_
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
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................17
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
.............................................................