VALDOXAN Film-coated tablet Ref.[6100] Active ingredients: Agomelatine

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France

Product name and form

Valdoxan 25 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet.

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.

Active Ingredient

Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. Agomelatine resynchronises circadian rhythms in animal models of circadian rhythm disruption. Agomelatine increases noradrenaline and dopamine release specifically in the frontal cortex and has no influence on the extracellular levels of serotonin.
List of Excipients

Tablet core:

Lactose monohydrate
Maize starch
Povidone (K30)
Sodium starch glycolate type A
Stearic acid
Magnesium stearate
Silica, colloidal anhydrous

Film-coating:

Hypromellose
Yellow iron oxide (E172)
Glycerol
Macrogol (6000)
Magnesium stearate
Titanium dioxide (E171)

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.

Marketing authorization holder

Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France

Marketing authorization dates and numbers

EU/1/08/499/002
EU/1/08/499/003
EU/1/08/499/005
EU/1/08/499/006
EU/1/08/499/007
EU/1/08/499/008

Date of first authorisation: 19 February 2009
Date of latest renewal: 12 December 2018

Drugs

Drug Countries
VALDOXAN Austria, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom
 
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