NAT-ERLOTINIB TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Saatavilla:

NATCO PHARMA (CANADA) INC

ATC-koodi:

L01EB02

INN (Kansainvälinen yleisnimi):

ERLOTINIB

Annos:

150MG

Lääkemuoto:

TABLET

Koostumus:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2018-12-14

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
NAT-ERLOTINIB
Erlotinib hydrochloride tablets
25 mg, 100 mg and 150 mg
erlotinib
Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor
Protein Kinase Inhibitor (L01XE03)
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1,
Suite 200
Mississauga, Ontario, Canada
L5N 1P7
Date of Revision:
July15, 2020
SUBMISSION CONTROL NO: 238581
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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
.................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 20
STORAGE AND STABILITY
..........................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
........................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
..........................................................................