WEGOVY SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SEMAGLUTIDE

Tersedia dari:

NOVO NORDISK CANADA INC

Kode ATC:

A10BJ06

INN (Nama Internasional):

SEMAGLUTIDE

Dosis:

6.8MG

Bentuk farmasi:

SOLUTION

Komposisi:

SEMAGLUTIDE 6.8MG

Rute administrasi :

SUBCUTANEOUS

Unit dalam paket:

100

Jenis Resep:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0159870008; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-06-30

Karakteristik produk

Wegovy™ (semaglutide injection) Product Monograph
Page 1 of 60
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
WEGOVY
®
semaglutide injection
Solution for Subcutaneous Injection in a pre-filled pen
Single-use pre-filled pen delivering doses of 0.25 mg, 0.5 mg, 1 mg,
1.7 mg or 2.4 mg
0.25 mg/pen (0.25 mg/0.5 mL)
0.5 mg/pen (0.5 mg/0.5 mL)
1 mg/pen (1 mg/0.5 mL)
1.7 mg/pen (1.7 mg/0.75mL)
2.4 mg/pen (2.4 mg/0.75mL)
and
Multi-use pre-filled pen (FlexTouch
®
) delivering doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg or
2.4 mg
1 mg/pen (0.68 mg/mL)
2 mg/pen (1.34 mg/mL)
4 mg/pen (1.34 mg/mL)
6.8 mg/pen (2.27 mg/mL)
9.6 mg/pen (3.2 mg/mL)
ATC code: A10BJ06
Glucagon-like Peptide-1 (GLP-1) Receptor Agonist
Novo Nordisk Canada Inc.
101-2476 Argentia Road
Mississauga, Ontario
L5N 6M1
Date of Initial Authorization:
November 23, 2021
Date of Revision:
June 29, 2023
Submission Control No: 266244
_ _
Wegovy
®
(semaglutide injection) Product Monograph
Page 2 of 60
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
TBD
4 DOSAGE AND ADMINISTRATION
TBD
7 WARNINGS AND PRECAUTIONS
TBD
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
.................................................. 4
1
INDICATIONS
......................................................................................................
4
1.1
Pediatrics
.....................................................................................................
4
1.2
Geriatrics
.....................................................................................................
5
2
CONTRAINDICATIONS
......................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................... 5
4
DOSAGE AND ADMINISTRATION
.................................................................