NOVO-VALPROIC CAPSULE (ENTERIC-COATED)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

VALPROIC ACID

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

N03AG01

INN (Kansainvälinen yleisnimi):

VALPROIC ACID

Annos:

500MG

Lääkemuoto:

CAPSULE (ENTERIC-COATED)

Koostumus:

VALPROIC ACID 500MG

Antoreitti:

ORAL

Kpl paketissa:

100/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTICONVULSANTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0112996003; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2018-05-02

Valmisteyhteenveto

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