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Re: DewDiligence post# 175836

Friday, 03/21/2014 4:07:05 PM

Friday, March 21, 2014 4:07:05 PM

Post# of 257275
It is under EMA new informed consent application, thus should be the same product as Relvar Ellipta with same ATC code. CHMP gave positive opinion on identical product UMEC/VI as Anoro and Laventair last month:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002027.jsp&mid=WC0b01ac058004d5c1

So my guess is GSK wants to market each of these two products, FF/VI and UMEC/VI, as two different brand products in EU, probably in different territories. They filed two applications simultaneously for UMEC/VI obviously, filed FF/VI under new informed consent application after Relvar Ellipta's approval.

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