Product Information
Registration Status: ActiveSIN13770P
VALDOXAN TABLET 25MG is approved to be sold in Singapore with effective from 2010-02-26. It is marketed by SERVIER (S) PTE LTD, with the registration number of SIN13770P.
This product contains Agomelatine 25mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by LES LABORATOIRES SERVIER INDUSTRIE [LSI] in FRANCE, andSERVIER (IRELAND) INDUSTRIES LTD. [SII] in IRELAND.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Agomelatine is structurally closely related to melatonin. Agomelatine is a potent agonist at melatonin receptors and an antagonist at serotonin-2C (5-HT2C) receptors, tested in an animal model of depression. Agomelatine was discovered and developed by the European pharmaceutical company Servier Laboratories Ltd. Servier continue to develop the drug and conduct phase III trials in the European Union. In 2005 Servier submitted Agomelatine to the European Medicines Agency (EMEA). On 27 July 2006 the Committee for Medical Products for Human Use (CHMP) of the EMEA recommended a refusal of the marketing authorisation of Valdoxan/Thymanax. The major concern was that efficacy had not been sufficiently shown. In 2006 Servier sold the rights to develop Agomelatine in the US to Novartis. The development for the US market was discontinued in October 2011. It is currently sold in Australia under the Valdoxan trade name.
Indication
Agomelatine is indicated for the treatment of major depressive episodes in adults.
Mechanism of Action
The novel antidepressant agent, agomelatine, behaves as an agonist at melatonin receptors (MT1 and MT2) and as an antagonist at serotonin (5-HT)(2C) receptors.
Pharmacokinetics
- Absorption
- Bioavailability is less than 5%.
- Distribution
- Metabolism
- Hepatic (90% CYP1A2 and 10% CYP2C9).
- Elimination
Active Ingredient/Synonyms
Valdoxan | Agomelatine |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.