🇪🇺 Vedrop in European Union

EMA authorised Vedrop on 23 July 2009

Marketing authorisation

EMA — authorised 23 July 2009

  • Application: EMEA/H/C/000920
  • Marketing authorisation holder: Recordati Rare Diseases
  • Local brand name: Vedrop
  • 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.
  • Pathway: exceptional circumstances
  • Status: approved

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Vedrop in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in European Union

Frequently asked questions

Is Vedrop approved in European Union?

Yes. EMA authorised it on 23 July 2009.

Who is the marketing authorisation holder for Vedrop in European Union?

Recordati Rare Diseases holds the EU marketing authorisation.