SANDOZ VALPROIC CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

VALPROIC ACID

Dostopno od:

SANDOZ CANADA INCORPORATED

Koda artikla:

N03AG01

INN (mednarodno ime):

VALPROIC ACID

Odmerek:

250MG

Farmacevtska oblika:

CAPSULE

Sestava:

VALPROIC ACID 250MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS ANTICONVULSANTS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2019-08-01

Lastnosti izdelka

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_Page 1 of 48 _
PRODUCT MONOGRAPH
PR
SANDOZ VALPROIC
Valproic Acid
250 mg Capsules
Mfr. Std.
Antiepileptic
Sandoz Canada Inc.
Date of Revision: December 18, 2018
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Submission Control No: 222665
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_Page 2 of 48 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
19
DRUG INTERACTIONS
.........................................................................................................
23
DOSAGE AND ADMINISTRATION
.....................................................................................
31
OVERDOSAGE
........................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
34
STORAGE AND STABILITY
.................................................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 36
PART II: SCIENTIFIC INFORMATION
................................................................................
37
PHARMACEUTICAL INFORMATION
.................................................................................
37
CLINICAL TRIALS
............................................................................................................