RATIO-VALPROIC CAPSULE

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

VALPROIC ACID

可用日期:

TEVA CANADA LIMITED

ATC代码:

N03AG01

INN（国际名称）:

VALPROIC ACID

剂量:

250MG

药物剂型:

CAPSULE

组成:

VALPROIC ACID 250MG

给药途径:

ORAL

每包单位数:

100/500

处方类型:

Prescription

治疗领域:

MISCELLANEOUS ANTICONVULSANTS

產品總結:

Active ingredient group (AIG) number: 0112996001; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2018-05-18

产品特点

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
.................................................................................................................