EMGALITY SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

GALCANEZUMAB

Disponibil de la:

ELI LILLY CANADA INC

Codul ATC:

N02CD02

INN (nume internaţional):

GALCANEZUMAB

Dozare:

120MG

Forma farmaceutică:

SOLUTION

Compoziție:

GALCANEZUMAB 120MG

Calea de administrare:

SUBCUTANEOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

CALCITONIN-GENE-RELATED PEPTIDE (CGRP) ANTAGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0161690001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2019-07-30

Caracteristicilor produsului

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