Compromisos posteriores a la comercialización

Requisitos y compromisos posteriores a la comercialización

Pueden consultar las obligaciones relativas a farmacovigilancia en la página web de la Agencia Europea del Medicamento y en la página web de la Agencia Norteamericana del Medicamento.

También se ha incorporado la siguiente información, pero puede estar sujeta a modificaciones en función de futuras conversaciones con las autoridades reguladoras:

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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Información de prescripción

Las indicaciones pueden variar en cada país. La información local de prescripción de su país es la fuente primordial de información relativa a los riesgos conocidos asociados a ocrelizumab.