Is Patisiran approved by the US FDA?

Drugs@FDA lists 1 application product line for Patisiran, including ONPATTRO (Prescription).

Is Patisiran authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Patisiran: Onpattro.

Are there safety signals or safety updates for Patisiran?

US FDA: 1 entry (latest 2022-10-03).

Active substance

Patisiran

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
ONPATTRO	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	solution · intravenous	ALNYLAM PHARMS INC	Prescription	10 Aug 2018

EMA European Union — centrally authorised medicines

Onpattro Alnylam Netherlands B.V. · Authorised · authorised 27 Aug 2018 · ATC N07

Therapeutic indication (EMA)

Onpattro is indicated for the 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
ONPATTRO	02489252	2 MG / ML	SOLUTION · INTRAVENOUS	ALNYLAM NETHERLANDS B.V.

Safety signals and safety-related labeling changes

US FDA 3 Oct 2022 ONPATTRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for patisiran →

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.