EPIVAL TABLET (DELAYED-RELEASE)

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

VALPROIC ACID (DIVALPROEX SODIUM)

から入手可能:

BGP PHARMA ULC

ATCコード:

N03AG01

INN（国際名）:

VALPROIC ACID

投薬量:

250MG

医薬品形態:

TABLET (DELAYED-RELEASE)

構図:

VALPROIC ACID (DIVALPROEX SODIUM) 250MG

投与経路:

ORAL

パッケージ内のユニット:

100/500

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS ANTICONVULSANTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2015-01-07

製品の特徴

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_EPIVAL®, divalproex sodium Product Monograph_
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_Page 1 of 65_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
EPIVAL®
divalproex sodium
Delayed-Release Tablets, 125 mg, 250 mg, 500 mg valproic acid (as
divalproex sodium), Oral
Manufacturer’s Standard
Antiepileptic
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
DEC 22, 2014
Date of Revision:
FEB 06, 2023
Submission Control Number: 266467
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_EPIVAL®, divalproex sodium Product Monograph_
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_Page 2 of 65_
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
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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
.........................