Thymanax
Withdrawn
agomelatine
Medicine
Human
Withdrawn
On 31 July 2022, the European Commission withdrew the marketing authorisation for Thymanax (agomelatine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Servier (Ireland) Industries Ltd., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Thymanax was granted marketing authorisation in the EU on 19 February 2009 for treatment of major depressive disorder. The product had not been marketed in the EU since 2021.
Thymanax was a duplicate application to Valdoxan, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Valdoxan.
The European Public Assessment Report (EPAR) for Thymanax is updated to indicate that the marketing authorisation is no longer valid.
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
Treatment of major depressive episodes in adults.