Posted by Marty on November 24, 2008, at 22:22:29
In reply to Re: Agomelatine -) 67 days before EMEA decision. » Marty, posted by jrbecker76 on November 24, 2008, at 11:32:37
JrBecker,I'm not familiar with the ways of the EMEA and therefore I'm glad to learn that the way the EMEA works, CHMP positive opinion is a guarantee of EMEA approval.
As a Canadian, I don't think we'll see Agomelatine anytime soon. Here, Ziprasidone (FDA approval in 2001) just got marketed and no Aripiprazole (FDA approval in 2002) yet. That's the price we pay for not acting faster and stronger about our famous Canadian online pharmacies. This is in no way a secret or a conspiracy theory as it has been publicly reported and discussed in the media a couple years ago.
Can I ask you if you work in a field related to neurology / psychiatry ?
/\/\arty
> 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.
poster:Marty
thread:864397
URL: http://www.dr-bob.org/babble/20081123/msgs/865116.html