1. octaplas ® / octaplasLG ® Regulatory History
Barbara Rangetiner, Ph.D.
Director Regulatory Affairs
Octapharma PPGmbH
Vienna, Austria
BPAC Meeting, Rockville, MD
September 20, 2012

2. 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

3. 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

4. octaplasLG ® - Pendings
Country
octaplasLG®
USA
Submission Dec 2011
Due date Oct 22, 2012

5. octaplas ® - Pendings Countries octaplas® Brazil 2009 Egypt 2010
Belarus
2012