TEVA-ERLOTINIB TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

L01EB02

INN (International Nazwa):

ERLOTINIB

Dawkowanie:

150MG

Forma farmaceutyczna:

TABLET

Skład:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2014-12-08

Charakterystyka produktu

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