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
Vedrop 50 mg/ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Slightly viscous, pale yellow solution. |
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 |
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:
Not all pack sizes may be marketed.
Recordati Rare Diseases, Immeuble “le Wilson”, 70 avenue du Général de Gaulle, 92800, Puteaux, France
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
| Drug | Countries | |
|---|---|---|
| VEDROP | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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