RATIO-VALPROIC CAPSULE (ENTERIC-COATED)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

VALPROIC ACID

MAH:

TEVA CANADA LIMITED

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:

MARKETED

authorization_date:

2007-07-13

SPC

PRODUCT MONOGRAPH
PR
RATIO-VALPROIC
(VALPROIC ACID)
Capsules
Capsules (250 mg and 500 mg)
USP
Antiepileptic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Preparation :
July 24, 2013
Submission Control No: 166248
2
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
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
26
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND STABILITY
.................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 32
PART II: SCIENTIFIC INFORMATION
....................................................................................
33
PHARMACEUTICAL INFORMATION
.................................................................................
33
CLINICAL TRIALS
.................................................................................................................