APO-VALPROIC ACID CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

VALPROIC ACID

Предлага се от:

APOTEX INC

АТС код:

N03AG01

INN (Международно Name):

VALPROIC ACID

дозиране:

250MG

Лекарствена форма:

CAPSULE

Композиция:

VALPROIC ACID 250MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Терапевтична област:

MISCELLANEOUS ANTICONVULSANTS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

1998-06-01

Данни за продукта

_APO-VALPROIC ACID (Valproic Acid Capsules) _
_ _
_Page 1 of 78 _
_APO-VALPROIC ACID ORAL SOLUTION (Valproic Acid Oral Solution)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-VALPROIC ACID
Valproic Acid Capsules
Capsules, 250 mg, Oral
USP
Pr
APO-VALPROIC ACID ORAL SOLUTION
Valproic Acid Oral Solution
Oral solution, 250 mg / 5 mL valproic acid (as sodium valproate), Oral
USP
Antiepileptic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Submission Control Number: 278761
Date of Initial Authorization:
AUG
13, 2021
Date of Revision:
OCT 05, 2023
_APO-VALPROIC ACID (Valproic Acid Capsules) _
_ _
_Page 2 of 78 _
_APO-VALPROIC ACID ORAL SOLUTION (Valproic Acid Oral Solution)_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Hepatotoxicity
10/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
04/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism:
Hyperammonemia
10/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism: Patients at
Risk of Hypocarnitinemia
10/2023
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic: Serious or
Fatal Hepatotoxicity
10/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric: Behavioural Disorders
04/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
04/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women, Pregnancy
Exposure Risk related to Valproate
10/2023
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
Pediatric