PHL-DIVALPROEX TABLET (ENTERIC-COATED)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-02-2013
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Active ingredient:
VALPROIC ACID (DIVALPROEX SODIUM)
Available from:
PHARMEL INC
ATC code:
N03AG01
INN (International Name):
VALPROIC ACID
Dosage:
125MG
Pharmaceutical form:
TABLET (ENTERIC-COATED)
Composition:
VALPROIC ACID (DIVALPROEX SODIUM) 125MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0112996004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2016-10-25
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PHL-DIVALPROEX
(Divalproex Sodium USP)
Enteric-Coated Tablets (125 mg, 250 mg, 500 mg)
Antiepileptic
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Revision:
February 22, 2013
Submission Control No: 162202
_phl-DIVALPROEX Product Monograph _
_Page 2 of 51_
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
..................................................................................................16
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................29
OVERDOSAGE
................................................................................................................32
ACTION AND CLINICAL PHARMACOLOGY
............................................................32
STORAGE AND STABILITY
..........................................................................................35
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................35
PART II: SCIENTIFIC INFORMATION
...............................................................................37
PHARMACEUTICAL INFORMATION
..........................................................................37
CLINICAL TRIALS
..........................................................................................................38
DETAILED PHARMACOLOGY
................................................
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