NAT-ERLOTINIB TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
15-07-2020
이 제품에 대한 일부 문서는 현재 사용할 수 없습니다. 고객 서비스에 요청을 보내면 가능한 빨리 알려 드리겠습니다.
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유효 성분:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE)
제공처:
NATCO PHARMA (CANADA) INC
ATC 코드:
L01EB02
INN (국제 이름):
ERLOTINIB
복용량:
150MG
약제 형태:
TABLET
구성:
ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150MG
관리 경로:
ORAL
패키지 단위:
15G/50G
처방전 유형:
Prescription
치료 영역:
ANTINEOPLASTIC AGENTS
제품 요약:
Active ingredient group (AIG) number: 0151203003; AHFS:
승인 상태:
APPROVED
승인 날짜:
2018-12-14
제품 특성 요약
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
_Page 2 of 48_
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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