NOVO-VALPROIC CAPSULE
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
19-06-2014
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Werkstoffen:
VALPROIC ACID
Beschikbaar vanaf:
TEVA CANADA LIMITED
ATC-code:
N03AG01
INN (Algemene Internationale Benaming):
VALPROIC ACID
Dosering:
250MG
farmaceutische vorm:
CAPSULE
Samenstelling:
VALPROIC ACID 250MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100/500
Prescription-type:
Prescription
Therapeutisch gebied:
MISCELLANEOUS ANTICONVULSANTS
Product samenvatting:
Active ingredient group (AIG) number: 0112996001; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2018-05-02
Productkenmerken
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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