Active ingredients: Agomelatine
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.
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.
Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. In humans, agomelatine has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.
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).
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