VALDOXAN Film-coated tablets (2019)
Active ingredients: Agomelatine
Product Name and Form
Valdoxan 25 mg film-coated tablets.
Film-coated tablet (tablet).
Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet with blue imprint of company logo on one side.
Qualitative and Quantitative Composition
Each film-coated tablet contains 25 mg of agomelatine.
Excipient with known effect: Each film-coated tablet contains 61.8 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
Sodium starch glycolate type A
Silica, colloidal anhydrous
Yellow iron oxide (E172)
Titanium dioxide (E171)
Printing ink containing shellac, propylene glycol and indigo carmine aluminium lake (E132).
Pack sizes and Marketing
Aluminium/PVC blister packed in cardboard boxes.
Calendar packs containing 14, 28, 56, 84 and 98 film-coated tablets.
Calendar packs of 100 film-coated tablets for hospital use.
Not all pack sizes may be marketed.
Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France
Date of first authorisation: 19 February 2009
Date of latest renewal: 13 November 2013