PMS-VALPROIC ACID CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VALPROIC ACID

Available from:

PHARMASCIENCE INC

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:

APPROVED

Authorization date:

1997-02-21

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-VALPROIC ACID
Valproic Acid Capsules, USP
Capsules, 250 mg, Oral
PR
PMS-VALPROIC ACID E.C.
Valproic Acid Enteric-Coated Capsules
Enteric-Coated Capsules, 500 mg, Oral
PR
PMS-VALPROIC ACID
Valproic Acid (as sodium valproate) Oral Solution, USP
Oral Solution, 250 mg /5 mL, Oral
Antiepileptic
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Submission Control Number: 274180
Date of Initial Authorization:
SEP 26, 1996
Date of Revision:
JULY 18, 2023
_pms-VALPROIC ACID & pms-VALPROIC ACID E.C. (valproic acid) _
_Page 2 of 71 _
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
......................................................................................................................
4
1.2
Geriatrics
.......................................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.................................................................. 5
4
DOSAGE AND ADMINISTRATION
......................................................................................
7
4.1
Dosing Considerations
..................................................................................................
7
4.2
Recommended Dos