AIMOVIG SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ERENUMAB

Sẵn có từ:

NOVARTIS PHARMACEUTICALS CANADA INC

Mã ATC:

N02CD01

INN (Tên quốc tế):

ERENUMAB

Liều dùng:

140MG

Dạng dược phẩm:

SOLUTION

Thành phần:

ERENUMAB 140MG

Tuyến hành chính:

SUBCUTANEOUS

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

CALCITONIN-GENE-RELATED PEPTIDE (CGRP) ANTAGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0160530002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-04-11

Đặc tính sản phẩm

_AIMOVIG® (erenumab) _
_Page 1 of 63 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AIMOVIG®
(erenumab injection)
Solution for Injection, 70 mg/mL, for subcutaneous use
Solution for Injection, 140 mg/mL, for subcutaneous use
Professed Standard
Anti-Calcitonin gene-related peptide receptor (anti-CGRPR)
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
Date of Initial Authorization:
August 01, 2018
Date of Revision:
October 27, 2022
Submission Control Number: 264464
® AIMOVIG & SureClick are registered trademarks of Amgen Inc. used
under license by
Novartis Pharmaceuticals Canada Inc.
_ _
_AIMOVIG® (erenumab) _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
7.0 WARNINGS AND PRECAUTIONS, Constipation with Serious
Complications
09/2022
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
4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.1
Dosing Considerations
.........................................................................................4
4.2
Recommended Dose and Dosage
Adjustment.............