PHL-VALPROIC ACID SYRUP
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-01-2012
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Active ingredient:
VALPROIC ACID (SODIUM VALPROATE)
Available from:
PHARMEL INC
ATC code:
N03AG01
INN (International Name):
VALPROIC ACID
Dosage:
250MG
Pharmaceutical form:
SYRUP
Composition:
VALPROIC ACID (SODIUM VALPROATE) 250MG
Administration route:
ORAL
Units in package:
450ML
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0112996002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2012-01-28
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PHL-VALPROIC ACID
Valproic Acid Capsules, USP
250 mg
PR
PHL-VALPROIC ACID E.C.
Valproic Acid Enteric Coated Capsules
500 mg
PR
PHL-VALPROIC ACID
Valproic Acid Oral Solution, USP
250 mg/5 mL
ANTIEPILEPTIC
PHARMEL INC.
DATE OF REVISION:
6111 Royalmount Avenue, suite 100
January 27, 2012
Montreal, Canada
H4P 2T4
SUBMISSION CONTROL NO: 152317
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
16
DRUG INTERACTIONS
.................................................................................................
20
DOSAGE AND ADMINISTRATION
.............................................................................
29
OVERDOSAGE................................................................................................................
31
ACTION AND CLINICAL
PHARMACOLOGY............................................................
32
STORAGE AND STABILITY
.........................................................................................
35
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 35
PART II: SCIENTIFIC INFORMATION
.............................................................................
36
PHARMACEUTICAL INFORMATION
.........................................................................
36
CLINICAL TRIALS
.........................................................................................................
37
DETAILED PHARMACOLOGY
....................................................................................
43
TOXICOLOGY..
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