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10 in addition to the list of follow-up measures discussed and requested by the cmdh, the chmp requested the following follow-up measures to be submitted to the national competent authorities and to be assessed under the co-ordination of the rms: • to perform a post-marketing study to confirm the safety and efficacy of xeomin after repeated injections (up to 6 injection sessions).
papildus apsekošanas pasākumu sarakstam, ko apsprieda un pieprasīja cmdh, chmp pieprasīja turpmāk minētos apsekošanas pasākumus, kuru rezultāti jāziņo valstu kompetentām iestādēm un jānovērtē rms koordinācijā: • veikt pēcreģistrācijas pētījumu, lai apstiprinātu xeomin nekaitīgumu un efektivitāti pēc atkārtotām injekcijām (līdz 6 injekciju sesijām).
Last Update: 2011-10-23
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