EPIVAL TABLET (DELAYED-RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

VALPROIC ACID (DIVALPROEX SODIUM)

Dostopno od:

BGP PHARMA ULC

Koda artikla:

N03AG01

INN (mednarodno ime):

VALPROIC ACID

Odmerek:

500MG

Farmacevtska oblika:

TABLET (DELAYED-RELEASE)

Sestava:

VALPROIC ACID (DIVALPROEX SODIUM) 500MG

Pot uporabe:

ORAL

Enote v paketu:

100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS ANTICONVULSANTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2015-01-07

Lastnosti izdelka

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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
.........................