MYL-DIVALPROEX TABLET (DELAYED-RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

VALPROIC ACID (DIVALPROEX SODIUM)

MAH:

MYLAN PHARMACEUTICALS ULC

ATC_code:

N03AG01

INN:

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

leaflet_short:

Active ingredient group (AIG) number: 0112996001; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2017-01-11

SPC

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
.....................................................................................