TARO-DASATINIB TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DASATINIB

제공처:

TARO PHARMACEUTICALS INC

ATC 코드:

L01EA02

INN (국제 이름):

DASATINIB

복용량:

70MG

약제 형태:

TABLET

구성:

DASATINIB 70MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 0152198003; AHFS:

승인 상태:

APPROVED

승인 날짜:

2020-05-21

제품 특성 요약

Page 1 of 65
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-DASATINIB
Dasatinib Tablets
20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg dasatinib
Protein-tyrosine kinase inhibitor
TARO PHARMACEUTICALS INC.
130 East Drive,
Brampton, Ontario
Canada L6T 1C1
Date of Revision:
March 19, 2021
Submission Control No: 245318
Page 2 of 65
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
.............................................................................................
14
DRUG INTERACTIONS
.............................................................................................
28
DOSAGE AND ADMINISTRATION
..........................................................................
30
OVERDOSAGE
...........................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 33
STORAGE AND STABILITY
.....................................................................................
35
SPECIAL HANDLING INSTRUCTIONS
................................................................... 35
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 35
PART II: SCIENTIFIC INFORMATION
..........................................................................
37
PHARMACEUTICAL INFORMATION
......................................................................
37
CLINICAL TRIALS
.........................................................................................