Requisiti e impegni in fase di post-marketing

 

Gli obblighi in materia di farmacovigilanza post-marketing sono riportati per riferimento sui siti Web dell'Agenzia europea per i medicinali e della Food and Drug Administration statunitense.

Sono state inoltre presentate (pur essendo potenzialmente soggette a modifica in base all'esito di eventuali ulteriori discussioni con le autorità di regolamentazione) le seguenti informazioni:
MANUSCRIPT: Long-Term Surveillance of Ocrelizumab-Treated Patients with Multiple Sclerosis.
Wormser D, Butzkueven H, Hillert J, et al. Presented at the European Academy of Neurology (EAN) in Oslo, Norway; June 29–July 2, 2019.
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VERISMO: A Post-Marketing Safety Study to Determine the Incidence of All Malignancies and Breast Cancer in Patients With Multiple Sclerosis Treated With Ocrelizumab
Wormser D, Evershed J, Ferreira G, et al. Presented at the American Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania; May 4–10, 2019.
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Integration of Ocrelizumab Safety Data From the German Study CONFIDENCE Into the Global Post-Marketing Safety Studies MANUSCRIPT and VERISMO.
Ziemssen T, Berthold H, Dirks P, et al. Presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany; October 10–12, 2018.
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Design of the Ocrelizumab Pregnancy Registry to Assess Maternal, Fetal and Infant Outcomes in Women With Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy.
Wormser D, Engel P, Hahn K, et al. Presented at the American Academy of Neurology (AAN) Annual Meeting in Los Angeles, California; April 21–27, 2018.
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Design of a Multi-Source Post-Marketing Study to Evaluate Pregnancy and Infant Outcomes in Women With Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy.
Margulis AV, Andrews EB, Hernandez-Diaz S, et al. Presented at the American Academy of Neurology (AAN) Annual Meeting in Los Angeles, California; April 21–27, 2018.
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Informazioni posologiche

Le indicazioni variano da un paese all'altro. Le informazioni posologiche per il proprio paese rappresentano la principale fonte di informazioni in merito ai rischi noti e potenziali associati all'uso dell'ocrelizumab.