MYLAN-DIVALPROEX TABLET (DELAYED-RELEASE)

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

VALPROIC ACID (DIVALPROEX SODIUM)

可用日期:

MYLAN PHARMACEUTICALS ULC

ATC代码:

N03AG01

INN（国际名称）:

VALPROIC ACID

剂量:

250MG

药物剂型:

TABLET (DELAYED-RELEASE)

组成:

VALPROIC ACID (DIVALPROEX SODIUM) 250MG

给药途径:

ORAL

每包单位数:

100/500

处方类型:

Prescription

治疗领域:

MISCELLANEOUS ANTICONVULSANTS

產品總結:

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

授权状态:

APPROVED

授权日期:

2016-11-16

产品特点

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_MYLAN-DIVALPROEX (divalproex sodium)_
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_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
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_MYLAN-DIVALPROEX (divalproex sodium)_
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_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
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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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
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5
1.1
Pediatrics
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5
1.2
Geriatrics
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