APO-MYCOPHENOLIC ACID TABLET (ENTERIC-COATED)

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)

Доступна з:

APOTEX INC

Код атс:

L04AA06

ІПН (Міжнародна Ім'я):

MYCOPHENOLIC ACID

Дозування:

180MG

Фармацевтична форма:

TABLET (ENTERIC-COATED)

Склад:

MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM) 180MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

120

Тип рецепту:

Prescription

Терапевтична области:

IMMUNOSUPPRESSIVE AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0150521001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2014-05-06

Характеристики продукта

_Pr_
_APO-MYCOPHENOLIC ACID (_Mycophenolic acid delayed-release tablets) _
Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-MYCOPHENOLIC ACID
Mycophenolic acid delayed-release tablets
Delayed-release tablets, 180 mg and 360 mg mycophenolic acid (as
mycophenolate sodium), Oral
USP
Immunosuppressant
ATC code: L04AA06
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 06, 2014
Date of Revision:
NOV 10, 2022
Submission Control Number: 264756
_Pr_
_APO-MYCOPHENOLIC ACID (_Mycophenolic acid delayed-release tablets) _
Page 2 of 43 _
RECENT MAJOR LABEL CHANGES
None at the time of authorisation
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
......................................................................
4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
.........................................................................................................
4
1.2
Geriatrics..........................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................... 4
4
DOSAGE AND
ADMINISTRATION....................................................................................
5
4.1
Dosing Considerations
......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.................................