PHL-VALPROIC ACID E.C. CAPSULE (ENTERIC-COATED)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

VALPROIC ACID

Mevcut itibaren:

PHARMEL INC

ATC kodu:

N03AG01

INN (International Adı):

VALPROIC ACID

Doz:

500MG

Farmasötik formu:

CAPSULE (ENTERIC-COATED)

Kompozisyon:

VALPROIC ACID 500MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/500

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS ANTICONVULSANTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2016-10-25

Ürün özellikleri

PRODUCT MONOGRAPH
PR
PHL-VALPROIC ACID
Valproic Acid Capsules, USP
250 mg
PR
PHL-VALPROIC ACID E.C.
Valproic Acid Enteric Coated Capsules
500 mg
PR
PHL-VALPROIC ACID
Valproic Acid Oral Solution, USP
250 mg/5 mL
ANTIEPILEPTIC
PHARMEL INC.
DATE OF REVISION:
6111 Royalmount Avenue, suite 100
January 27, 2012
Montreal, Canada
H4P 2T4
SUBMISSION CONTROL NO: 152317
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION....................................................... 3
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
16
DRUG INTERACTIONS
.................................................................................................
20
DOSAGE AND ADMINISTRATION
.............................................................................
29
OVERDOSAGE................................................................................................................
31
ACTION AND CLINICAL
PHARMACOLOGY............................................................
32
STORAGE AND STABILITY
.........................................................................................
35
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 35
PART II: SCIENTIFIC INFORMATION
.............................................................................
36
PHARMACEUTICAL INFORMATION
.........................................................................
36
CLINICAL TRIALS
.........................................................................................................
37
DETAILED PHARMACOLOGY
....................................................................................
43
TOXICOLOGY..