TEVA-DIVALPROEX TABLET (ENTERIC-COATED)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
02-05-2017
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Active ingredient:
VALPROIC ACID (DIVALPROEX SODIUM)
Available from:
TEVA CANADA LIMITED
ATC code:
N03AG01
INN (International Name):
VALPROIC ACID
Dosage:
250MG
Pharmaceutical form:
TABLET (ENTERIC-COATED)
Composition:
VALPROIC ACID (DIVALPROEX SODIUM) 250MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0112996001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2020-06-10
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
TEVA-DIVALPROEX
(Divalproex Sodium Enteric-Coated Tablets)
125, 250, 500 mg
USP
Antiepileptic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No.: 204247
Date of Revision:
May 1, 2017
_ TEVA-DIVALPROEX_
_ _
_Product Monograph_
_Page 2 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL
USE...........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
..............................................................................................
21
DRUG INTERACTIONS
...............................................................................................
27
DOSAGE AND ADMINISTRATION
...........................................................................
37
OVERDOSAGE
.............................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 41
STORAGE AND STABILITY
......................................................................................
44
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 44
PART II: SCIENTIFIC INFORMATION
............................................................................
45
PHARMACEUTICAL INFORMATION
......................................................................
45
CLINICAL
TRIALS.......................................................................................................
45
DETAILED PHARMACOLOGY
.................................................................................
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