Is Tocofersolan authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tocofersolan: Vedrop.

Is Tocofersolan authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Tocofersolan, including VEDROP 50 MG/ML ORAL SOLUTION.

Active substance

Tocofersolan

EMA 1
UK MHRA 1

Open in the medicines table

EMA European Union — centrally authorised medicines

Vedrop Recordati Rare Diseases · Authorised · authorised 23 Jul 2009 · ATC A11HA08

Therapeutic indication (EMA)

Vedrop is indicated in vitamin-E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
VEDROP 50 MG/ML ORAL SOLUTION	PLGB 15266/0025	RECORDATI RARE DISEASES	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.