MYL-DIVALPROEX TABLET (DELAYED-RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

VALPROIC ACID (DIVALPROEX SODIUM)

Disponible des:

MYLAN PHARMACEUTICALS ULC

Codi ATC:

N03AG01

Designació comuna internacional (DCI):

VALPROIC ACID

Dosis:

250MG

formulario farmacéutico:

TABLET (DELAYED-RELEASE)

Composición:

VALPROIC ACID (DIVALPROEX SODIUM) 250MG

Vía de administración:

ORAL

Unidades en paquete:

100/500

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANTICONVULSANTS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2017-01-11

Fitxa tècnica

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
_Page 2 of 47_
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
.....................................................................................