TEVA-DIVALPROEX TABLET (ENTERIC-COATED)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

VALPROIC ACID (DIVALPROEX SODIUM)

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

N03AG01

INN (International Adı):

VALPROIC ACID

Doz:

125MG

Farmasötik formu:

TABLET (ENTERIC-COATED)

Kompozisyon:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/500

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS ANTICONVULSANTS

Ürün özeti:

Active ingredient group (AIG) number: 0112996004; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2020-06-10

Ürün özellikleri

PRODUCT MONOGRAPH
PR
TEVA-DIVALPROEX
(Divalproex Sodium Enteric-Coated Tablets)
125, 250, 500 mg
USP
Antiepileptic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No.: 204247
Date of Revision:
May 1, 2017
_ TEVA-DIVALPROEX_
_ _
_Product Monograph_
_Page 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
..............................................................................................
21
DRUG INTERACTIONS
...............................................................................................
27
DOSAGE AND ADMINISTRATION
...........................................................................
37
OVERDOSAGE
.............................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 41
STORAGE AND STABILITY
......................................................................................
44
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 44
PART II: SCIENTIFIC INFORMATION
............................................................................
45
PHARMACEUTICAL INFORMATION
......................................................................
45
CLINICAL
TRIALS.......................................................................................................
45
DETAILED PHARMACOLOGY
.................................................................................