Vedrop (tocofersolan)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tocofersolan
- Company
- Recordati Rare Diseases
- Status
- Authorised
- Therapeutic area
- Cholestasis; Vitamin E Deficiency
- EU approval
- Thu 23 Jul 2009
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/000920
- ATC
- A11HA08
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.