PHL-DIVALPROEX TABLET (ENTERIC-COATED)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

VALPROIC ACID (DIVALPROEX SODIUM)

MAH:

PHARMEL INC

ATC_code:

N03AG01

INN:

VALPROIC ACID

dosage:

250MG

pharmaceutical_form:

TABLET (ENTERIC-COATED)

composition:

VALPROIC ACID (DIVALPROEX SODIUM) 250MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

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

authorization_status:

CANCELLED POST MARKET

authorization_date:

2016-10-25

SPC

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