MYLAN-DIVALPROEX TABLET (DELAYED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VALPROIC ACID (DIVALPROEX SODIUM)

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

N03AG01

INN (International Name):

VALPROIC ACID

Dosage:

500MG

Pharmaceutical form:

TABLET (DELAYED-RELEASE)

Composition:

VALPROIC ACID (DIVALPROEX SODIUM) 500MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

Active ingredient group (AIG) number: 0112996003; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-11-16

Summary of Product characteristics

_ _
_ _
_MYLAN-DIVALPROEX (divalproex sodium)_
_ _
_Page 1 of 70_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MYLAN-DIVALPROEX
divalproex sodium
Delayed-Release Tablets, 125 mg, 250 mg, 500 mg valproic acid (as
divalproex sodium), Oral
Manufacturer’s Standard
Antiepileptic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
NOV 16, 2016
Date of Revision:
MAR 14, 2024
Submission Control Number: 280863
_ _
_ _
_ _
_MYLAN-DIVALPROEX (divalproex sodium)_
_ _
_Page 2 of 70_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
02/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Hepatotoxicity
02/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
06/2022
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism:
Hyperammonemia
02/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism:
Patients at Risk of Hypocarnitinemia
02/2023
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic:
Serious or Fatal Hepatotoxicity
02/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric: Behavioural Disorders
10/2021
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
04/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women,
Pregnancy Exposure Risk related to Valproate
02/2023
_ _
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
.......................................................................
5
1
INDICATIONS
................................................................................................................
5
1.1
Pediatrics
.................................................................................................................
5
1.2
Geriatrics
...................