AMVUTTRA SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

VUTRISIRAN (VUTRISIRAN SODIUM)

Доступно од:

ALNYLAM NETHERLANDS B.V.

АТЦ код:

N07XX18

INN (Међународно име):

VUTRISIRAN

Дозирање:

25MG

Фармацеутски облик:

SOLUTION

Састав:

VUTRISIRAN (VUTRISIRAN SODIUM) 25MG

Пут администрације:

SUBCUTANEOUS

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2023-10-18

Карактеристике производа

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