MYL-DIVALPROEX TABLET (DELAYED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-10-2016
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Active ingredient:
VALPROIC ACID (DIVALPROEX SODIUM)
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
N03AG01
INN (International Name):
VALPROIC ACID
Dosage:
250MG
Pharmaceutical form:
TABLET (DELAYED-RELEASE)
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:
2017-01-11
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
MYL-DIVALPROEX
Divalproex Sodium Delayed-Release Tablets, USP
125 mg, 250 mg, 500 mg valproic acid (as divalproex sodium)
Anticonvulsant
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Control Number: 197330
Date of Revision:
September 08, 2016
_Page 2 of 47_
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
.........................................................................................................
29
DOSAGE
AND
ADMINISTRATION
.....................................................................................
37
OVERDOSAGE
.......................................................................................................................
40
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
40
STORAGE
AND
STABILITY
.................................................................................................
43
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 44
PART II: SCIENTIFIC INFORMATION
...............................................................................
45
PHARMACEUTICAL
INFORMATION
.................................................................................
45
CLINICAL
TRIALS
.....................................................................................
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