NAT-ERLOTINIB TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
15-07-2020
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ingredients actius:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE)
Disponible des:
NATCO PHARMA (CANADA) INC
Codi ATC:
L01EB02
Designació comuna internacional (DCI):
ERLOTINIB
Dosis:
150MG
formulario farmacéutico:
TABLET
Composición:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG
Vía de administración:
ORAL
Unidades en paquete:
15G/50G
tipo de receta:
Prescription
Área terapéutica:
ANTINEOPLASTIC AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0151203003; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2018-12-14
Fitxa tècnica
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
..........................................................................
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