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Halozyme Therapeutics, Inc. Message Board

  • dickunger2 dickunger2 Dec 21, 2013 10:39 AM Flag


    I wrote the EMA and this is the answer I got back:Dear Mr
    Thank you for your query of 19 November 2013 regarding an on-going procedure for Mabthera.
    A revised version of the Risk Management Plan (RMP) for this product will be discussed at the Pharmacovigilance Risk Assessment Committee (PRAC) meeting in January; the minutes of this meeting will be published on the European Medicines Agency’s (EMA) website around mid-February:
    Please note that the EMA is not able to comment further on the status of on-going evaluations until such evaluation is concluded.
    We hope you find this information helpful.
    Kind regards,
    Rosa Gonzalez-Quevedo
    Stakeholders and Communication
    European Medicines Agency\
    7 Westferry Circus | Canary Wharf | London E14 4HB | United Kingdom Less

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