AMVUTTRA SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

VUTRISIRAN (VUTRISIRAN SODIUM)

Disponível em:

ALNYLAM NETHERLANDS B.V.

Código ATC:

N07XX18

DCI (Denominação Comum Internacional):

VUTRISIRAN

Dosagem:

25MG

Forma farmacêutica:

SOLUTION

Composição:

VUTRISIRAN (VUTRISIRAN SODIUM) 25MG

Via de administração:

SUBCUTANEOUS

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2023-10-18

Características técnicas

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