Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Vedrop   
Auth. number : EU/1/09/533
Active substance : tocofersolan
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A11 - Vitamins
Pharmacological subgroup: A11H - Other plain vitamin preparations
Chemical subgroup: A11HA - Other plain vitamin preparations
Chemical substance: A11HA08 - Tocofersolan
(See WHO ATC Index)
Indication: Indicated in vitamin E deficiency due to digestive malabsorption in paediatric patients with congenital chronic cholestasis or hereditary chronic cholestasis, from birth (full term newborns) up to 18 years of age.
Marketing Authorisation Holder: Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
30/07/2009 Centralised - Authorisation EMEA/H/C/920 (2009)6078 of 24/07/2009
03/03/2011 Centralised - Annual reassessment EMEA/H/C/920/S/1 (2011)1487 of 28/02/2011
27/09/2011 Centralised - Variation EMEA/H/C/920/IG/111
Updated with Decision(2012)2455 of 10/04/2012
12/04/2012 Centralised - Variation (2012)2455 of 10/04/2012
04/09/2012 Centralised - Annual reassessment EMEA/H/C/920/S/2 (2012)6151 of 30/08/2012
08/11/2012 Centralised - Notification EMEA/H/C/920/N/5
Updated with Decision(2013)2398 of 22/04/2013
24/04/2013 Centralised - Annual reassessment EMEA/H/C/920/S/4 (2013)2398 of 22/04/2013
19/12/2013 Centralised - Variation EMEA/H/C/920/IG/392
Updated with Decision(2014)2044 of 21/03/2014
26/03/2014 Centralised - Annual reassessment EMEA/H/C/920/S/6 (2014)2044 of 21/03/2014
25/04/2014 Centralised - Renewal EMEA/H/C/920/R/7 (2014)2818 of 23/04/2014
20/11/2014 Centralised - Variation EMEA/H/C/920/II/11/G
Updated with Decision(2015)7842 of 06/11/2015
22/01/2015 Centralised - Annual reassessment EMEA/H/C/920/S/12
10/11/2015 Centralised - Yearly update (2015)7842 of 06/11/2015
28/01/2016 Centralised - Annual reassessment EMEA/H/C/920/S/15
14/02/2017 Centralised - Variation EMEA/H/C/IG/773/G
23/03/2017 Centralised - Annual reassessment EMEA/H/C/920/S/19
20/07/2017 Centralised - Variation EMEA/H/C/920/II/22