octaplas ® / octaplasLG ® Regulatory History Barbara Rangetiner, Ph.D. Director Regulatory Affairs Octapharma PPGmbH Vienna, Austria BPAC Meeting, Rockville, MD September 20, 2012
octaplas ® – Approvals later changed to octaplasLG ® Countries octaplas® octaplasLG® Germany 1989 2009 United Kingdom Portugal 1998 2011 2012 Switzerland 1999 2010 Belgium, Finland, Ireland, Luxembourg, Netherland, Sweden 2000 / 2001 Australia 2005
Gulf Central Committee Hungary, Kuwait, New Zealand octaplas ® - Approvals Countries Octaplas® Romania 1993 Austria 1994 Italy 2000 Norway 2001 Czech Rep, Slovakia, Saudi Arabia 2003 Gulf Central Committee United Arab Emirates 2004 Canada, Mexico, Oman 2005 Hungary, Kuwait, New Zealand 2006 Yemen 2007 Azerbaijan 2010 Kazakhstan, Malaysia 2011
octaplasLG ® - Pendings Country octaplasLG® USA Submission Dec 2011 Due date Oct 22, 2012
octaplas ® - Pendings Countries octaplas® Brazil 2009 Egypt 2010 Belarus 2012