Land: Canada
Sprog: engelsk
Kilde: Health Canada
TIRZEPATIDE
ELI LILLY CANADA INC
A10BX16
TIRZEPATIDE
5MG
SOLUTION
TIRZEPATIDE 5MG
SUBCUTANEOUS
100
Prescription
Active ingredient group (AIG) number: 0164301002; AHFS:
APPROVED
2022-11-24
_ _ _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 ........... Læs hele dokumentet