AMVUTTRA SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

VUTRISIRAN (VUTRISIRAN SODIUM)

Verfügbar ab:

ALNYLAM NETHERLANDS B.V.

ATC-Code:

N07XX18

INN (Internationale Bezeichnung):

VUTRISIRAN

Dosierung:

25MG

Darreichungsform:

SOLUTION

Zusammensetzung:

VUTRISIRAN (VUTRISIRAN SODIUM) 25MG

Verabreichungsweg:

SUBCUTANEOUS

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Produktbesonderheiten:

Active ingredient group (AIG) number: 0165141001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2023-10-18

Fachinformation

_Product Monograph _
_AMVUTTRA (vutrisiran injection) _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AMVUTTRA
®
vutrisiran injection
solution; 25 mg/0.5 mL vutrisiran (as vutrisiran sodium); subcutaneous
injection
ATC Code N07XX18
other nervous system drugs
Alnylam Netherlands B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
Netherlands
Imported / Distributed by:
Innomar-Strategies
Oakville, ON
L6L 0C4
Date of Initial Authorization:
October 17, 2023
Submission Control Number: 267923
_ _
_Product Monograph _
_AMVUTTRA (vutrisiran injection) _
_Page 2 of 26_
RECENT MAJOR LABEL CHANGES
There are no recent major changes to this Product Monograph.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
....................................................... 4
4.4
Administration
........................................................................................................
5
4.5
Missed Dose
.........................