Refused
This medicine was refused authorisation for use in the European Union.
Overview
On 27 July 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a marketi ng authorisation for the medicinal product Valdoxan/Thymanax, 25 mg film-coated tablets in tended for the treatment of major depressive disorder. The company that applied is Les Labor atoires Servier. The applicant requested a re- examination of the opinion, but withdrew this request before the CHMP completed the re-examination.
This EPAR was last updated on 27/07/2006
Application details
| Product details | |
|---|---|
| Name |
Valdoxan
|
| Active substance |
Agomelatine
|
| International non-proprietary name (INN) or common name |
Agomelatine
|
| Therapeutic area (MeSH) |
Depressive Disorder, Major
|
| Application details | |
|---|---|
| Marketing-authorisation applicant |
Les Laboratoires Servier
|
| Date of opinion |
27/07/2006
|
| Date of refusal of marketing authorisation |
16/01/2007
|