MOUNJARO SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

TIRZEPATIDE

Disponible depuis:

ELI LILLY CANADA INC

Code ATC:

A10BX16

DCI (Dénomination commune internationale):

TIRZEPATIDE

Dosage:

10MG

forme pharmaceutique:

SOLUTION

Composition:

TIRZEPATIDE 10MG

Mode d'administration:

SUBCUTANEOUS

Unités en paquet:

100

Type d'ordonnance:

Prescription

Descriptif du produit:

Active ingredient group (AIG) number: 0164301004; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2022-11-24

Résumé des caractéristiques du produit

_ _
_MOUNJARO (tirzepatide injection) _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MOUNJARO™
tirzepatide injection
Solution, 2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL,
12.5 mg/0.5 mL,
15 mg/0.5 mL, in a single-dose prefilled pen for subcutaneous use
Glucose-Dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like
Peptide-1 (GLP-1)
Receptor Agonist
Antihyperglycemic Agent
Eli Lilly Canada Inc.
Exchange Tower
130 King Street West, Suite 900
P.O. Box 73
Toronto, Ontario
M5X 1B1
1-888-545-5972
www.lilly.ca
Date of Initial Authorization:
NOV 23, 2022
Submission Control Number: 259103
MOUNJARO is a trademark owned by or licensed to Eli Lilly and Company,
its subsidiaries or
affiliates.
_ _
_MOUNJARO (tirzepatide injection) _
_Page 2 of 45_
RECENT MAJOR LABEL CHANGES
None at time of authorization
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...................................................... 5
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
...........