GLN-TOPIRAMATE TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

TOPIRAMATE

Disponibbli minn:

GLENMARK PHARMACEUTICALS CANADA INC.

Kodiċi ATC:

N03AX11

INN (Isem Internazzjonali):

TOPIRAMATE

Dożaġġ:

100MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

TOPIRAMATE 100MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS ANTICONVULSANTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED PRE MARKET

Data ta 'l-awtorizzazzjoni:

2018-07-17

Karatteristiċi tal-prodott

_Page 1 of 73 _
PRODUCT MONOGRAPH
PR
GLN-TOPIRAMATE
Topiramate Tablets
25, 100 and 200 mg
Antiepileptic/Migraine Prophylaxis
Glenmark Pharmaceuticals Canada Inc.
500 King St. West, 3
rd
Floor
Toronto, Ontario
M5V 1L9
Date of Preparation:
August 28, 2018
Submission Control No.: 218267
_Page 2 of 73 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
19
DRUG INTERACTIONS
.................................................................................................
36
DOSAGE AND ADMINISTRATION
.............................................................................
44
OVERDOSAGE
...............................................................................................................
48
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 48
STORAGE AND STABILITY
.........................................................................................
51
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 51
PART II: SCIENTIFIC INFORMATION
..............................................................................
52
PHARMACEUTICAL INFORMATION
.........................................................................
53
CLINICAL TRIALS
.........................................................................................................
54
DETAILED PHARMACOLOGY
........................................................