MYL-DIVALPROEX TABLET (DELAYED-RELEASE)

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

VALPROIC ACID (DIVALPROEX SODIUM)

Commercializzato da:

MYLAN PHARMACEUTICALS ULC

Codice ATC:

N03AG01

INN (Nome Internazionale):

VALPROIC ACID

Dosaggio:

250MG

Forma farmaceutica:

TABLET (DELAYED-RELEASE)

Composizione:

VALPROIC ACID (DIVALPROEX SODIUM) 250MG

Via di somministrazione:

ORAL

Confezione:

100/500

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTICONVULSANTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2017-01-11

Scheda tecnica

PRODUCT MONOGRAPH
PR
MYL-DIVALPROEX
Divalproex Sodium Delayed-Release Tablets, USP
125 mg, 250 mg, 500 mg valproic acid (as divalproex sodium)
Anticonvulsant
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Control Number: 197330
Date of Revision:
September 08, 2016
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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
.........................................................................................................
21
DRUG
INTERACTIONS
.........................................................................................................
29
DOSAGE
AND
ADMINISTRATION
.....................................................................................
37
OVERDOSAGE
.......................................................................................................................
40
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
40
STORAGE
AND
STABILITY
.................................................................................................
43
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 44
PART II: SCIENTIFIC INFORMATION
...............................................................................
45
PHARMACEUTICAL
INFORMATION
.................................................................................
45
CLINICAL
TRIALS
.....................................................................................