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.
Vedrop : EPAR - Summary for the public (PDF/80.61 KB)
First published: 06/08/2009
Last updated: 21/09/2017
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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.
Recordati Rare Diseases
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Immeuble le Wilson
16/05/2019 Vedrop - EMEA/H/C/000920 - IG/1085/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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.
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.