RINVOQ TABLET (EXTENDED-RELEASE)

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

UPADACITINIB

Доступна з:

ABBVIE CORPORATION

Код атс:

L04AF03

ІПН (Міжнародна Ім'я):

UPADACITINIB

Дозування:

30MG

Фармацевтична форма:

TABLET (EXTENDED-RELEASE)

Склад:

UPADACITINIB 30MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

15G/50G

Тип рецепту:

Prescription

Терапевтична области:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0162012002; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2021-10-06

Характеристики продукта

_RINVOQ (upadacitinib) _
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_Page 1 of 101_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RINVOQ®
Upadacitinib extended-release tablets
Extended-release tablets, 15 mg upadacitinib, oral
Extended-release tablets, 30 mg upadacitinib, oral
Extended-release tablets, 45 mg upadacitinib, oral
Selective immunosuppressant
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, QC H4S 1Z1
Date of Authorization:
DEC 23, 2019
Date of Revision:
OCT 31, 2023
Submission Control Number: 275958
_RINVOQ (upadacitinib) _
_ _
_Page 2 of 101_
RECENT MAJOR LABEL CHANGES
1 Indications
10/2023
1.1 Indications, Pediatrics
10/2023
3 Serious Warnings and Precautions Box
07/2022
4.1 Dosage and Administration, Dosing Considerations
10/2023
4.2 Dosage and Administration, Recommended Dose and Dosage Adjustment
10/2023
4.4 Dosage and Administration, Administration
10/2023
7 Warnings and Precautions
10/2023
7 Warnings and Precautions, 7.1.3 Pediatrics
10/2023
7 Warnings and Precautions, 7.1.4 Geriatrics
10/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
5
1
INDICATIONS
................................................................................................................
5
1.1
Pediatrics
.................................................................................................................
6
1.2
Geriatrics
.................................................................................................................
6
2
CONTRAINDICATIONS
..................................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 6
4
DOSAGE AND ADMINISTRATION
................................