Posted by jrbecker76 on November 24, 2008, at 11:32:37
In reply to Re: Agomelatine -) 67 days before EMEA decision. » jrbecker76, posted by Marty on November 24, 2008, at 9:39:45
> JB,
>
> Btw, I just saw in your Scribd version "EU: Approved" for Agomelatine. You consider CHMP positive opinion about Agomelatine as good as a real approval from the EMEA ? Is it your interpretation that there's no way the EMEA wouldn't approve a drug that the CHMP would approve or is it just an error ? If it's not an error than I'd like to have your opinion.
>
> /\/\artyMarty,
Perhaps I should have been more correct in listing agomelatine in the EU as a "positive opinion" rather than "approved" however, yes, receiving a positive opininion from the CHMP subcommittee is approval from the EMEA, but now the European Commission has to finally approve it. However, unlike with FDA panel recommendations that are sometimes disagreed upon when the FDA subsequently makes an official approval decision on a particular drug, the EC has almost always followed suit from the EMEA. So no need to still cross your fingers on this one, just have to be somewhat patient. As mentioned in a prior post, Servier will have to work with the separate countries to determine pricing and further regulatory matters before actual launch. Each EU member state has its own procedures for the authorization that fall outside the scope of the centralized procedure.
As for Neurotransmitter.net, Shawn is the host of the site, I just contribute to it.
JB
poster:jrbecker76
thread:864397
URL: http://www.dr-bob.org/babble/20081123/msgs/864998.html