Država: Kanada
Jezik: angleščina
Source: Health Canada
ERENUMAB
NOVARTIS PHARMACEUTICALS CANADA INC
N02CD01
ERENUMAB
70MG
SOLUTION
ERENUMAB 70MG
SUBCUTANEOUS
(1X1 ML) AND (2X1ML)
Prescription
CALCITONIN-GENE-RELATED PEPTIDE (CGRP) ANTAGONISTS
Active ingredient group (AIG) number: 0160530001; AHFS:
APPROVED
2018-08-01
_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............. Preberite celoten dokument