VEDROP Oral solution Ref.[9886] Active ingredients: Tocofersolan

Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Recordati Rare Diseases, Tour Hekla, 52 avenue du Général de Gaulle, 92800 Puteaux, France

Product name and form

Vedrop 50 mg/ml oral solution.

Pharmaceutical Form
Oral solution. Slightly viscous, pale yellow solution.

Qualitative and quantitative composition

Each ml contains 50 mg of d-alpha-tocopherol, in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.

Excipients:

Each ml contains 6 mg sodium methyl parahydroxybenzoate (E219), 4 mg sodium ethyl parahydroxybenzoate (E215) and 0.18 mmoles (4.1 mg) of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Tocofersolan	Vitamin E is the principal lipo-soluble antioxidant in the organism. It acts as a free radical chain breaking molecule, stopping the peroxidation of polyunsaturated fatty acids and it is involved in maintaining the stability and integrity of cell membranes. Tocofersolan is indicated in vitamin E deficiency due to digestive malabsorption in paediatric patients with congenital chronic cholestasis or hereditary chronic cholestasis.

List of Excipients
Potassium sorbate Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215) Glycerol Disodium phosphate dodecahydrate Concentrated hydrochloric acid Purified water

Pack sizes and marketing

Type III brown glass bottle with a child-resistant screw cap of HDPE and LDPE seal. Oral syringes with housing of LDPE and piston of polystyrol. Each bottle contains 10 ml, 20 ml or 60 ml of oral solution.

Boxes containing:

one 10 ml bottle and one 1 ml oral syringe
one 20 ml bottle and one 1 ml oral syringe
one 60 ml and one 2 ml oral syringe

Not all pack sizes may be marketed.

Marketing authorization holder

Recordati Rare Diseases, Tour Hekla, 52 avenue du Général de Gaulle, 92800 Puteaux, France

Marketing authorization dates and numbers

EU/1/09/533/001 10 ml bottle
EU/1/09/533/002 20 ml bottle
EU/1/09/533/003 60 ml bottle

Date of first authorisation: 24 July 2009
Date of latest renewal: 23 April 2014

Drugs

Drug	Countries
VEDROP	Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom

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