MYLAN-AZATHIOPRINE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

AZATHIOPRINE

から入手可能:

MYLAN PHARMACEUTICALS ULC

ATCコード:

L04AX01

INN（国際名）:

AZATHIOPRINE

投薬量:

50MG

医薬品形態:

TABLET

構図:

AZATHIOPRINE 50MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

IMMUNOSUPPRESSIVE AGENTS

製品概要:

Active ingredient group (AIG) number: 0101830001; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2017-11-14

製品の特徴

_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
.....