Vedrop
tocofersolan
Table of contents
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.
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) |
|
Anatomical therapeutic chemical (ATC) code |
A11HA08
|
Additional 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 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 |
Product information
16/05/2019 Vedrop - EMEA/H/C/000920 - IG/1085/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.