PHL-VALPROIC ACID E.C. CAPSULE (ENTERIC-COATED)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

VALPROIC ACID

MAH:

PHARMEL INC

ATC_code:

N03AG01

INN:

VALPROIC ACID

dosage:

500MG

pharmaceutical_form:

CAPSULE (ENTERIC-COATED)

composition:

VALPROIC ACID 500MG

administration_route:

ORAL

units_in_package:

100/500

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

Active ingredient group (AIG) number: 0112996003; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2016-10-25

SPC

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..