MYLAN-DIVALPROEX TABLET (DELAYED-RELEASE)

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

VALPROIC ACID (DIVALPROEX SODIUM)

थमां उपलब्ध:

MYLAN PHARMACEUTICALS ULC

ए.टी.सी कोड:

N03AG01

INN (इंटरनेशनल नाम):

VALPROIC ACID

डोज़:

125MG

फार्मास्यूटिकल फॉर्म:

TABLET (DELAYED-RELEASE)

रचना:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

प्रशासन का मार्ग:

ORAL

पैकेज में यूनिट:

100

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

MISCELLANEOUS ANTICONVULSANTS

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

APPROVED

प्राधिकरण की तारीख:

2016-11-16

उत्पाद विशेषताएं

_ _
_ _
_MYLAN-DIVALPROEX (divalproex sodium)_
_ _
_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
_ _
_ _
_ _
_MYLAN-DIVALPROEX (divalproex sodium)_
_ _
_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
_ _
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
...................