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planu zarządzania ryzykiem (rmp) przedstawionego w module 1. 8. 2.
the mah commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan, as agreed in version dated 23 may 2008 of the risk management plan (rmp) presented in module 1.8.2. of the marketing authorisation application and any subsequent updates of the rmp agreed by the chmp.
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