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Ironwood Pharmaceuticals, Inc. Message Board

  • consj90 consj90 Nov 21, 2012 10:04 AM Flag

    European Approval!

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    • That article looks months old and doesn't mean that there is european approval, just the suggestion by one board that they should approve it. Do you have information that they have approved it in europe?

      • 1 Reply to mershaw2001
      • 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

        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.

14.34Jul 28 4:00 PMEDT