TEVA-ARIPIPRAZOLE TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
03-07-2020
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有効成分:
ARIPIPRAZOLE
から入手可能:
TEVA CANADA LIMITED
ATCコード:
N05AX12
INN（国際名）:
ARIPIPRAZOLE
投薬量:
15MG
医薬品形態:
TABLET
構図:
ARIPIPRAZOLE 15MG
投与経路:
ORAL
パッケージ内のユニット:
30/100
処方タイプ:
Prescription
治療領域:
ATYPICAL ANTIPSYCHOTICS
製品概要:
Active ingredient group (AIG) number: 0152514003; AHFS:
認証ステータス:
CANCELLED POST MARKET
承認日:
2021-07-29
製品の特徴
PRODUCT MONOGRAPH
PR TEVA-ARIPIPRAZOLE
Aripiprazole Tablets, USP
2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
Antipsychotic agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
Date of Preparation:
July 03, 2020
www.tevacanada.com
Submission Control No: 240750
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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
.........................................................................................................
14
DRUG INTERACTIONS
.........................................................................................................
31
DOSAGE AND ADMINISTRATION
.....................................................................................
35
OVERDOSAGE
........................................................................................................................
37
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
38
STORAGE AND STABILITY
.................................................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 40
PART II: SCIENTIFIC INFORMATION
...................................................................................
42
PHARMACEUTICAL INFORMATION
.................................................................................
42
CLINICAL TRIALS
..................................................
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