RATIO-VALPROIC-CAP 250MG CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Cumpara asta acum

Ingredient activ:

VALPROIC ACID

Disponibil de la:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

Codul ATC:

N03AG01

INN (nume internaţional):

VALPROIC ACID

Dozare:

250MG

Forma farmaceutică:

CAPSULE

Compoziție:

VALPROIC ACID 250MG

Calea de administrare:

ORAL

Unități în pachet:

100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MISCELLANEOUS ANTICONVULSANTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2014-09-19

Caracteristicilor produsului

                                PRODUCT MONOGRAPH
PR
RATIO-VALPROIC
(VALPROIC ACID)
Capsules
Capsules (250 mg and 500 mg)
USP
Antiepileptic
Ratiopharm Inc.
Date of Revision:
17 800 Lapointe
March 8, 2012
Mirabel, Quebec
Canada J7J 1P3
Control No.: 152387
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.....................................................................................
26
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND
STABILITY.................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 32
PART II: SCIENTIFIC
INFORMATION....................................................................................
33
PHARMACEUTICAL
INFORMATION.................................................................................
33
CLINICAL
TRIALS.................................................................................................................
34
DETAILED
PHARMACOLOGY.........................
                                
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