Exigences et engagements post-commercialisation

 

Les obligations de pharmacovigilance après la mise sur le marché peuvent être consultées sur les sites Web de l’Agence européenne des médicaments et du Secrétariat américain aux produits alimentaires et pharmaceutiques (FDA).

Les informations suivantes ont également été présentées mais peuvent faire l’objet de modifications selon l’issue d’éventuelles discussions ultérieures menées avec les autorités réglementaires.
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.
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.
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.
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.
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.

Informations posologiques

Les indications varient en fonction des différents pays. Les informations posologiques locales provenant de votre pays constituent la première source d’information sur les risques connus et potentiels associés à l’ocrelizumab.