Is Eplontersen 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 Eplontersen, including Wainua (45 mg, Solution for injection, SAR 150944.45).

Is Eplontersen approved by the US FDA?

Drugs@FDA lists 2 application product lines for Eplontersen, including WAINUA (AUTOINJECTOR) (Prescription); WAINUA (Prescription).

Is Eplontersen authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Eplontersen: Wainzua.

Are there safety signals or safety updates for Eplontersen?

US FDA: 1 entry (latest 2026-04-15).

Active substance

Eplontersen

SFDA 1
US FDA 2
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
Wainua	45 mg	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 150944.45	NCE · Prescription	AstraZeneca	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
WAINUA (AUTOINJECTOR)	EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)	solution · subcutaneous	ASTRAZENECA AB	Prescription	21 Dec 2023
WAINUA	EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)	solution · subcutaneous	ASTRAZENECA AB	Prescription	21 Dec 2023

EMA European Union — centrally authorised medicines

Wainzua AstraZeneca AB · Authorised · authorised 6 Mar 2025 · ATC N07XX21

Therapeutic indication (EMA)

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

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
WAINUA	02548909	45 MG / 0.8 ML	SOLUTION · SUBCUTANEOUS	ASTRAZENECA CANADA INC

Safety signals and safety-related labeling changes

US FDA 15 Apr 2026 WAINUA (AUTOINJECTOR) — safety-related labeling change
Labeling sections changed: Patient Counseling Information / Patient Information / Medication Guide

All safety entries for eplontersen →

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.