NAT-ERLOTINIB TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Commercializzato da:

NATCO PHARMA (CANADA) INC

Codice ATC:

L01EB02

INN (Nome Internazionale):

ERLOTINIB

Dosaggio:

150MG

Forma farmaceutica:

TABLET

Composizione:

ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2018-12-14

Scheda tecnica

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