GLN-TOPIRAMATE TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

TOPIRAMATE

可用日期:

GLENMARK PHARMACEUTICALS CANADA INC.

ATC代码:

N03AX11

INN（国际名称）:

TOPIRAMATE

剂量:

100MG

药物剂型:

TABLET

组成:

TOPIRAMATE 100MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

MISCELLANEOUS ANTICONVULSANTS

產品總結:

Active ingredient group (AIG) number: 0132938002; AHFS:

授权状态:

APPROVED

授权日期:

2014-09-02

产品特点

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_GLN-TOPIRAMATE (Topiramate Tablets) _
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_Page 1 of 76 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GLN-TOPIRAMATE
Topiramate Tablets
Tablets, 25 mg, 100 mg, and 200 mg, Oral
USP
Antiepileptic / Migraine Prophylaxis
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West, Suite 407
Concord, Ontario
L4K 4M2
Date of Initial Authorization:
November 03, 2006
Date of Revision:
January 23, 2024
Submission Control Number: 278404
_Pr_
_GLN-TOPIRAMATE (Topiramate Tablets) _
_ _
_Page 2 of 76 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, OPHTHALMOLOGIC
01/2023
7 WARNINGS AND PRECAUTIONS, REPRODUCTIVE HEALTH: FEMALE AND
MALE POTENTIAL, TERATOGENIC RISK
01/2024
7 WARNINGS AND PRECAUTIONS, INFORMATION FOR PATIENTS, FETAL
TOXICITY
01/2024
7.1.1 PREGNANT WOMEN
01/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
_ _
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1 INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
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