NOVO-VALPROIC CAPSULE
Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
Ürün özellikleri
(SPC)
19-06-2014
Bu ürün için bazı belgeler şu anda mevcut değil, müşteri hizmetlerimize bir istek gönderebilirsiniz ve bunları alır almaz size bildireceğiz.
İstek gönder.
İstek gönder.
Aktif bileşen:
VALPROIC ACID
Mevcut itibaren:
TEVA CANADA LIMITED
ATC kodu:
N03AG01
INN (International Adı):
VALPROIC ACID
Doz:
250MG
Farmasötik formu:
CAPSULE
Kompozisyon:
VALPROIC ACID 250MG
Uygulama yolu:
ORAL
Paketteki üniteler:
100/500
Reçete türü:
Prescription
Terapötik alanı:
MISCELLANEOUS ANTICONVULSANTS
Ürün özeti:
Active ingredient group (AIG) number: 0112996001; AHFS:
Yetkilendirme durumu:
CANCELLED POST MARKET
Yetkilendirme tarihi:
2018-05-02
Ürün özellikleri
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
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