AA-CLOZAPINE TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

CLOZAPINE

可用日期:

AA PHARMA INC

ATC代码:

N05AH02

INN（国际名称）:

CLOZAPINE

剂量:

50MG

药物剂型:

TABLET

组成:

CLOZAPINE 50MG

给药途径:

ORAL

每包单位数:

100/500

处方类型:

Prescription

治疗领域:

ATYPICAL ANTIPSYCHOTICS

產品總結:

Active ingredient group (AIG) number: 0122583003; AHFS:

授权状态:

APPROVED

授权日期:

2016-11-08

产品特点

_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)_
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_ _
_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
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6
4.2 Recommended Dose and Dosage Adjustment
.......................................