AIMOVIG SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ERENUMAB

Διαθέσιμο από:

NOVARTIS PHARMACEUTICALS CANADA INC

Φαρμακολογική κατηγορία (ATC):

N02CD01

INN (Διεθνής Όνομα):

ERENUMAB

Δοσολογία:

70MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

ERENUMAB 70MG

Οδός χορήγησης:

SUBCUTANEOUS

Μονάδες σε πακέτο:

(1X1 ML) AND (2X1ML)

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

CALCITONIN-GENE-RELATED PEPTIDE (CGRP) ANTAGONISTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0160530001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-08-01

Αρχείο Π.Χ.Π.

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