Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284, Suresnes cedex, France
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. |
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 | 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 Film-coating: Hypromellose 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
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: 13 November 2013
| 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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