NAT-ERLOTINIB TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
15-07-2020
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Aktivní složka:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE)
Dostupné s:
NATCO PHARMA (CANADA) INC
ATC kód:
L01EB02
INN (Mezinárodní Name):
ERLOTINIB
Dávkování:
150MG
Léková forma:
TABLET
Složení:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG
Podání:
ORAL
Jednotky v balení:
15G/50G
Druh předpisu:
Prescription
Terapeutické oblasti:
ANTINEOPLASTIC AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0151203003; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2018-12-14
Charakteristika produktu
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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