AG-TOPIRAMATE TABLETS

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

TOPIRAMATE

Pieejams no:

ANGITA PHARMA INC.

ATĶ kods:

N03AX11

SNN (starptautisko nepatentēto nosaukumu):

TOPIRAMATE

Deva:

100MG

Zāļu forma:

TABLET

Kompozīcija:

TOPIRAMATE 100MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2023-03-30

Produkta apraksts

_ _
_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
...............................................................................................
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