DIVALPROEX TABLET (DELAYED-RELEASE)

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

VALPROIC ACID (DIVALPROEX SODIUM)

Commercializzato da:

APOTEX INC

Codice ATC:

N03AG01

INN (Nome Internazionale):

VALPROIC ACID

Dosaggio:

125MG

Forma farmaceutica:

TABLET (DELAYED-RELEASE)

Composizione:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTICONVULSANTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0112996004; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2021-05-27

Scheda tecnica

_DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) _
_Page 1 of 77_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DIVALPROEX
Divalproex Sodium Delayed-Release Tablets
Delayed-Release Tablets, 125 mg, 250 mg and 500 mg valproic acid (as
divalproex sodium),
Oral
Apotex Standard
Antiepileptic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
May 27, 2021
Date of Revision:
November 9, 2022
Submission Control Number: 264752
_DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) _
_Page 2 of 77_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
11/2022
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic: Serious or
Fatal Hepatotoxicity
11/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric: Behavioural Disorders
11/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
11/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women, Pregnancy
Exposure Risk related to Valproate
11/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES.......................................................................................
2
TABLE OF CONTENTS
.........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 4
1
INDICATIONS
.........................................................................................................
4
1.1
Pediatrics
......................................................................................................
4
1.2
Geriatrics
......................................................................................................
4
2
CONTRAINDICATIONS
............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
....................................................... 6
4