Requisitos e compromissos após introdução no mercado

 

As obrigações de farmacovigilância após introdução no mercado estão disponíveis para consulta no site da Agência Europeia de Medicamentos e no site da Food and Drug Administration dos E.U.A.

A informação que se segue também foi apresentada, mas pode estar sujeita a alterações com base em quaisquer outras conversas com 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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Informações de prescrição

As indicações poderão variar em diferentes países. As informações de prescrição locais do seu país são a principal fonte de informação sobre os riscos potenciais e conhecidos associados ao ocrelizumab.