RATIO-VALPROIC-CAP 250MG CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-10-2016
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Active ingredient:
VALPROIC ACID
Available from:
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
ATC code:
N03AG01
INN (International Name):
VALPROIC ACID
Dosage:
250MG
Pharmaceutical form:
CAPSULE
Composition:
VALPROIC ACID 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:
2014-09-19
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
RATIO-VALPROIC
(VALPROIC ACID)
Capsules
Capsules (250 mg and 500 mg)
USP
Antiepileptic
Ratiopharm Inc.
Date of Revision:
17 800 Lapointe
March 8, 2012
Mirabel, Quebec
Canada J7J 1P3
Control No.: 152387
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.........................................................................................................
16
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND
ADMINISTRATION.....................................................................................
26
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND
STABILITY.................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 32
PART II: SCIENTIFIC
INFORMATION....................................................................................
33
PHARMACEUTICAL
INFORMATION.................................................................................
33
CLINICAL
TRIALS.................................................................................................................
34
DETAILED
PHARMACOLOGY.........................
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