Is Volanesorsen authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Volanesorsen: Waylivra.

Is Volanesorsen authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Volanesorsen, including WAYLIVRA 285 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE.

Active substance

Volanesorsen

EMA 1
UK MHRA 1

Open in the medicines table

EMA European Union — centrally authorised medicines

Waylivra Akcea Therapeutics Ireland Limited · Authorised · authorised 3 May 2019 · ATC C10AX18

Therapeutic indication (EMA)

Waylivra is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
WAYLIVRA 285 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE	PLGB 51704/0003	AKCEA THERAPEUTICS IRELAND LIMITED	POM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.