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VALDOXAN Film-coated tablets (2019)

Active ingredients: Agomelatine

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 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.

Chemical substance
Description
Agomelatine

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.

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)

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.

Marketing authorization holder
Authorization dates

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

Date of first authorisation: 19 February 2009
Date of latest renewal: 13 November 2013

Marketing authorization number:

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