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müügiloa hoidja kohustub teostama uuringud ja riskijuhtimisplaanis kirjeldatud täiendavad ravimohutusjärelvalve toimingud, vastavalt kokku lepitud riskijuhtimisplaani versioonile 9.november 2007, mis sisaldub müügiloa taotluse moodulis 1.8.2 ning mistahes järgnevates riskijuhtimisplaanides, millega inimtervishoius kasutatatvate ravimite komitee (chmp) on nõustunud.
the mah commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan, as agreed in version of 9 november 2007 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.
Last Update: 2017-04-26
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