AG-TOPIRAMATE TABLETS

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

TOPIRAMATE

Beschikbaar vanaf:

ANGITA PHARMA INC.

ATC-code:

N03AX11

INN (Algemene Internationale Benaming):

TOPIRAMATE

Dosering:

100MG

farmaceutische vorm:

TABLET

Samenstelling:

TOPIRAMATE 100MG

Toedieningsweg:

ORAL

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2023-03-30

Productkenmerken

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_AG-Topiramate Tablets_
_Page 1 of 73_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-TOPIRAMATE TABLETS
Topiramate Tablets
Tablets, 25 mg, 100 mg and 200 mg, oral
USP
Antiepileptic/Migraine Prophylaxis
Angita Pharma Inc.
1310 Nobel Street
Boucherville, Québec
J4B 5H3
Date of Initial Authorization:
MAR 30, 2023
Submission Control Number: 272943
_ _
_AG-Topiramate Tablets_
_Page 2 of 73_
RECENT MAJOR LABEL CHANGES
N/A
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
....................................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
.............................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
...........................................................................................................
7
4.5
Missed Dose
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7
5
OVE