NOVO-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:

CANCELLED POST MARKET

authorization_date:

2018-05-02

SPC

PRODUCT MONOGRAPH
PR
NOVO-VALPROIC
(Valproic Acid)
250 mg Capsules, USP Standard
500 mg Enteric Coated Capsules, Teva Standard
Antiepileptic
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
June 19, 2014
Toronto, Ontario
M1B 2K9
CONTROL NO.: 174447
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
.....................................................................................
25
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 28
STORAGE AND STABILITY
.................................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 31
PART II: SCIENTIFIC INFORMATION
....................................................................................
32
PHARMACEUTICAL INFORMATION
.................................................................................
32
CLINICAL TRIALS
.................................................................................................................
33
D