NAT-ERLOTINIB TABLET
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
15-07-2020
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有效成分:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE)
可用日期:
NATCO PHARMA (CANADA) INC
ATC代码:
L01EB02
INN（国际名称）:
ERLOTINIB
剂量:
150MG
药物剂型:
TABLET
组成:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG
给药途径:
ORAL
每包单位数:
15G/50G
处方类型:
Prescription
治疗领域:
ANTINEOPLASTIC AGENTS
產品總結:
Active ingredient group (AIG) number: 0151203003; AHFS:
授权状态:
APPROVED
授权日期:
2018-12-14
产品特点
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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