Vedrop

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tocofersolan

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Vedrop. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vedrop.

For practical information about using Vedrop, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 22/08/2019

Authorisation details

Product details
Name
Vedrop
Agency product number
EMEA/H/C/000920
Active substance
tocofersolan
International non-proprietary name (INN) or common name
tocofersolan
Therapeutic area (MeSH)
  • Cholestasis
  • Vitamin E Deficiency
Anatomical therapeutic chemical (ATC) code
A11HA08
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Publication details
Marketing-authorisation holder
Recordati Rare Diseases
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
23/07/2009
Contact address

Immeuble le Wilson
70, avenue du Général de Gaulle
92800 Puteaux
France

Product information

16/05/2019 Vedrop - EMEA/H/C/000920 - IG/1085/G

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

VITAMINS

Therapeutic indication

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.

Assessment history

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