Is Vutrisiran registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Vutrisiran, including Amvuttra (25 mg, Solution for injection, SAR 326996.55).

Is Vutrisiran approved by the US FDA?

Drugs@FDA lists 1 application product line for Vutrisiran, including AMVUTTRA (Prescription).

Is Vutrisiran authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Vutrisiran: Amvuttra.

Are there safety signals or safety updates for Vutrisiran?

US FDA: 1 entry (latest 2025-03-20).

Active substance

Vutrisiran

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Amvuttra	25 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 326996.55	NCE · Prescription	Alnylam Netherlands B.V	Valid

Indications — CHI Daman Drug Formulary

AMYLOIDOSIS - HEREDITARY WILD-TYPE TRANSTHYRETIN-RELATED (hATTR)

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
AMVUTTRA	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	solution · subcutaneous	ALNYLAM PHARMS INC	Prescription	13 Jun 2022

EMA European Union — centrally authorised medicines

Amvuttra Alnylam Netherlands B.V. · Authorised · authorised 15 Sep 2022 · ATC N07XX18

Therapeutic indication (EMA)

Treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AMVUTTRA	02542420	25 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ALNYLAM NETHERLANDS B.V.

Safety signals and safety-related labeling changes

US FDA 20 Mar 2025 AMVUTTRA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations

All safety entries for vutrisiran →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.