GLN-TOPIRAMATE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

TOPIRAMATE

Pieejams no:

GLENMARK PHARMACEUTICALS CANADA INC.

ATĶ kods:

N03AX11

SNN (starptautisko nepatentēto nosaukumu):

TOPIRAMATE

Deva:

100MG

Zāļu forma:

TABLET

Kompozīcija:

TOPIRAMATE 100MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

MISCELLANEOUS ANTICONVULSANTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2014-09-02

Produkta apraksts

_Pr_
_GLN-TOPIRAMATE (Topiramate Tablets) _
_ _
_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
.........................................................................................
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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