TEVA-ERLOTINIB TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Beschikbaar vanaf:

TEVA CANADA LIMITED

ATC-code:

L01EB02

INN (Algemene Internationale Benaming):

ERLOTINIB

Dosering:

100MG

farmaceutische vorm:

TABLET

Samenstelling:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30

Prescription-type:

Prescription

Therapeutisch gebied:

ANTINEOPLASTIC AGENTS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2014-12-08

Productkenmerken

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