MYLAN-DIVALPROEX TABLET (DELAYED-RELEASE)

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

VALPROIC ACID (DIVALPROEX SODIUM)

Dostupno od:

MYLAN PHARMACEUTICALS ULC

ATC koda:

N03AG01

INN (International ime):

VALPROIC ACID

Doziranje:

125MG

Farmaceutski oblik:

TABLET (DELAYED-RELEASE)

Sastav:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

MISCELLANEOUS ANTICONVULSANTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2016-11-16

Svojstava lijeka

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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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