WELIREG TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

BELZUTIFAN

Disponibbli minn:

MERCK CANADA INC

Kodiċi ATC:

L01XX74

INN (Isem Internazzjonali):

BELZUTIFAN

Dożaġġ:

40MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

BELZUTIFAN 40MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0163901001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2022-07-11

Karatteristiċi tal-prodott

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_WELIREG® (belzutifan) _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
WELIREG®
belzutifan tablets
Tablets, 40 mg, Oral
Antineoplastic agent
Merck Canada Inc.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
Date of Initial Authorization:
JUL 11, 2022
Date of Revision:
JUL 10, 2023
Submission Control Number: 270609
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_WELIREG® (belzutifan) _
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
1 Indications
07/2023
7 Warnings and Precautions
0
7
/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
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1 Pediatrics
.......................................................................................................................
4
1.2 Geriatrics
.......................................................................................................................
4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1 Dosing Considerations
..................................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
............................................................. 5
4.4 Administration
........................................................................