Riik: Kanada
keel: inglise
Allikas: Health Canada
GALCANEZUMAB
ELI LILLY CANADA INC
N02CD02
GALCANEZUMAB
100MG
SOLUTION
GALCANEZUMAB 100MG
SUBCUTANEOUS
3X1ML
Prescription
CALCITONIN-GENE-RELATED PEPTIDE (CGRP) ANTAGONISTS
Active ingredient group (AIG) number: 0161690002; AHFS:
APPROVED
2020-09-17
_EMGALITY_ _®_ _ Product Monograph _ _Page 1 of 51_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR EMGALITY ® Galcanezumab Injection 100 mg/mL solution for subcutaneous injection 120 mg/mL solution for subcutaneous injection CGRP binding antibody 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 Approval: July 30, 2019 Date of Revision: September 17, 2020 Submission Control No: 232324 EMGALITY is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries or affiliates. _ _ _EMGALITY_ _®_ _ Product Monograph _ _Page 2 of 51_ RECENT MAJOR LABEL CHANGES Indications (1) 09/2020 Dosage and Administration, Dosing Considerations (3.1) 09/2020 Dosage and Administration, Recommended Dose and Dosage Adjustment (3.2) 09/2020 Dosage and Administration, Administration (3.3) 09/2020 Dosage and Administration, Missed Dose (3.4) 09/2020 Warnings and Precautions (7) 09/2020 Warnings and Precautions, Pregnant Women (7.1.1) 09/2020 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4 1 INDICATIONS ...................................................................................................... 4 1.1 Pediatrics ..................................................................................................... 4 1.2 Geriatrics ..................................................................................................... 4 2 CONTRAINDICATIONS ....................................................................................... 4 3 DOSAGE AND ADMINISTRATION ..................................................................... 4 3.1 Dosing Considerations................................................................................. 4 3.2 Recommended Dose and Dosage Adjustment ............................................ 4 3.3 Administration ............................................................................. Lugege kogu dokumenti