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

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Recordati Rare Diseases, Immeuble le Wilson, 70 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
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, Immeuble “le Wilson”, 70 avenue du Général de Gaulle, 92800, Puteaux, France

Marketing authorization dates and numbers

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

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

Drugs

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

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