MYLAN-VALPROIC CAPSULE

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

VALPROIC ACID

Доступно од:

MYLAN PHARMACEUTICALS ULC

АТЦ код:

N03AG01

INN (Међународно име):

VALPROIC ACID

Дозирање:

250MG

Фармацеутски облик:

CAPSULE

Састав:

VALPROIC ACID 250MG

Пут администрације:

ORAL

Јединице у пакету:

100/500

Тип рецептора:

Prescription

Терапеутска област:

MISCELLANEOUS ANTICONVULSANTS

Резиме производа:

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

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2016-06-28

Карактеристике производа

1
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PRODUCT MONOGRAPH
PR
MYLAN-VALPROIC
Valproic Acid Capsules, USP
250 mg
Antiepileptic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke Ontario
M8Z 2S6
Date of Revision: May 7, 2015
Submission Control No.: 184065
2
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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
...........................................................................................................
20
DRUG INTERACTIONS
...........................................................................................................
24
DOSAGE AND ADMINISTRATION
......................................................................................
34
OVERDOSAGE
..........................................................................................................................
37
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
37
STORAGE AND STABILITY
...................................................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 40
PART II: SCIENTIFIC INFORMATION ...................................................................................
41
PHARMACEUTICAL INFORMATION
..................................................................................
41
CLINICAL TRIALS
.....................................................................................................................
42
DETAILED P