AA-CLOZAPINE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CLOZAPINE

제공처:

AA PHARMA INC

ATC 코드:

N05AH02

INN (International Name):

CLOZAPINE

복용량:

25MG

약제 형태:

TABLET

구성:

CLOZAPINE 25MG

관리 경로:

ORAL

패키지 단위:

100/500

처방전 유형:

Prescription

치료 영역:

ATYPICAL ANTIPSYCHOTICS

제품 요약:

Active ingredient group (AIG) number: 0122583001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2003-08-07

제품 특성 요약

_AA-CLOZAPINE (Clozapine Tablets)_
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_Page 1 of 55 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AA-CLOZAPINE
Clozapine Tablets
Tablets, 25 mg, 50 mg, 100 mg and 200 mg, oral
USP
Antipsychotic Agent
AA PHARMA INC.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
AUG 19, 2016
Date of Revision:
APRIL 03, 2023
Submission Control Number: 269276
_AA-CLOZAPINE (Clozapine Tablets)_
_ _
_ _
_Page 2 of 55 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
04/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
04/2023
7 WARNINGS AND PRECAUTIONS, General, Anticholinergic Activity
04/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
................................................................................................
2
TABLE OF CONTENTS
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2
1 INDICATIONS
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4
1.1 Pediatrics
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5
1.2 Geriatrics
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5
2 CONTRAINDICATIONS
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5
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
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6
4 DOSAGE AND ADMINISTRATION
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6
4.1 Dosing Considerations
...........................................................................................................
6
4.2 Recommended Dose and Dosage Adjustment
.......................................