EMGALITY SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GALCANEZUMAB

Available from:

ELI LILLY CANADA INC

ATC code:

N02CD02

INN (International Name):

GALCANEZUMAB

Dosage:

100MG

Pharmaceutical form:

SOLUTION

Composition:

GALCANEZUMAB 100MG

Administration route:

SUBCUTANEOUS

Units in package:

3X1ML

Prescription type:

Prescription

Therapeutic area:

CALCITONIN-GENE-RELATED PEPTIDE (CGRP) ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0161690002; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-09-17

Summary of Product characteristics

_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
.............................................................................