MYLAN-DIVALPROEX TABLET (DELAYED-RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

VALPROIC ACID (DIVALPROEX SODIUM)

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

N03AG01

INN (Nama Internasional):

VALPROIC ACID

Dosis:

125MG

Bentuk farmasi:

TABLET (DELAYED-RELEASE)

Komposisi:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS ANTICONVULSANTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2016-11-16

Karakteristik produk

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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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