MYLAN-AZATHIOPRINE TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
24-11-2014
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유효 성분:
AZATHIOPRINE
제공처:
MYLAN PHARMACEUTICALS ULC
ATC 코드:
L04AX01
INN (International Name):
AZATHIOPRINE
복용량:
50MG
약제 형태:
TABLET
구성:
AZATHIOPRINE 50MG
관리 경로:
ORAL
패키지 단위:
100
처방전 유형:
Prescription
치료 영역:
IMMUNOSUPPRESSIVE AGENTS
제품 요약:
Active ingredient group (AIG) number: 0101830001; AHFS:
승인 상태:
CANCELLED POST MARKET
승인 날짜:
2017-11-14
제품 특성 요약
_Page 1 of 26_
PRODUCT MONOGRAPH
PR
MYLAN-AZATHIOPRINE
Azathioprine Tablets
50 mg
USP
Immunosuppressive Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 179082
Date of Revision: November 06, 2014
_Page 2 of 26_
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
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
...............................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
......................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 15
PART II: SCIENTIFIC INFORMATION
...............................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
.........................................................................................................
17
TOXICOLOGY
.....
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