Is Eladocagene exuparvovec authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Eladocagene exuparvovec: Upstaza.

Is Eladocagene exuparvovec authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Eladocagene exuparvovec, including UPSTAZA 2.8X1011 VECTOR GENOMES (VG)/0.5 ML SOLUTION FOR INFUSION.

Active substance

Eladocagene exuparvovec

EMA 1
UK MHRA 1

Open in the medicines table

EMA European Union — centrally authorised medicines

Upstaza PTC Therapeutics International Limited · Authorised · authorised 18 Jul 2022 · ATC A16AB26

Therapeutic indication (EMA)

Upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic L amino acid decarboxylase (AADC) deficiency with a severe phenotype (see section 5.1).

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
UPSTAZA 2.8X1011 VECTOR GENOMES (VG)/0.5 ML SOLUTION FOR INFUSION	PLGB 44221/0006	PTC THERAPEUTICS INTERNATIONAL 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.