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Re: Agomelatine - approved in Europe

Posted by jrbecker76 on November 22, 2008, at 9:24:49

In reply to Re: Agomelatine_got it, posted by Phillipa on November 21, 2008, at 11:00:22

Consider Agomelatine approved. The EC completely relies on the EMEA's CHMP subcommittee for its opinion. In terms of market launch though, there will now have to be some regulatory and pricing determinations made in each EU country, so a good approximate time frame for Servier to be able to get to market is around 6 months (each country will vary in timing).

http://www.servier.com/Pro/ContentPro.aspx?id=1181&=redirect


It might be a little longer for us on this side of the water. Novartis has now delayed its plan to submit agomelatine (AG) 178) until the 1st half of 09.

JB


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URL: http://www.dr-bob.org/babble/20081114/msgs/864609.html