European approval is expected by 12/21/12. Here is the relevant history:
5/4/09 Almirall deal signed which covers all country members of the European Union, plus
Russia, CIS, Switzerland, Norway and Turkey, as well as other countries of the former
Yugoslavia.
9/29/11 MAA submitted by Almirall
9/21/12 Positive CHMP opinion issued
The European Commission, which has the authority to approve medicines for use in the European Union, generally follows the recommendations of the CHMP and typically renders a final decision within three months of the CHMP opinion. If the CHMP recommendation is formally adopted by the European Commission, drug would be approved for marketing in all 27 member states of the European Union.