RINVOQ TABLET (EXTENDED-RELEASE)

Երկիր: Կանադա

Լեզու: անգլերեն

Աղբյուրը: Health Canada

Ակտիվ բաղադրիչ:

UPADACITINIB

Հասանելի է:

ABBVIE CORPORATION

ATC կոդը:

L04AF03

INN (Միջազգային անվանումը):

UPADACITINIB

Դոզան:

15MG

Դեղագործական ձեւ:

TABLET (EXTENDED-RELEASE)

Կազմը:

UPADACITINIB 15MG

Կառավարման երթուղին:

ORAL

Միավորները փաթեթում:

15G/50G

Ռեկվիզորի տեսակը:

Prescription

Թերապեւտիկ տարածք:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Ապրանքի ամփոփագիր:

Active ingredient group (AIG) number: 0162012001; AHFS:

Լիազորման կարգավիճակը:

APPROVED

Հաստատման ամսաթիվը:

2019-12-23

Ապրանքի հատկությունները

_RINVOQ (upadacitinib) _
_ _
_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
................................