Yes, this website includes post-marketing adverse event reports received by Roche. As part of our robust global pharmacovigilance process, these adverse event reports are reviewed, assessed, and due diligence is performed.
The FAERS database generally includes post-marketing cases reported by the Market Authorisation Holder (MAH). However, FAERS may also include reports from clinical trials based on the specific requirements set in FDA regulations along with reports that are submitted voluntarily to the FDA by other sources. As the FDA acknowledges, unverified information, as well as incomplete or duplicate cases, can be reported in the FAERS dashboard.
EudraVigilance is an EMA-operated, centralised European database of suspected adverse reactions to medicines authorised in the European Economic Area (EEA). Published cases are reported by Roche, another MAH or Regulatory Authority, but not directly by doctors or consumers. The information available relates to suspected side effects, i.e. medical events that have been observed following the use of a medicine, but which are not necessarily related to or caused by the medicine.
Differences between these databases and Roche-reported data arise from differences in the quality of reports (e.g. level of verification or status of causality assessment), delay between first entry and subsequent additional follow-up, confirmation or potential removal, or presence of duplicate cases.
We know that the community has high interest in the topics included on the site, and you can continue to reach out for further information by contacting the Roche affiliate in your country with any questions you may have regarding ocrelizumab. Indications vary in different countries. The local prescribing information from your country is the primary source of information on the known and potential risks associated with ocrelizumab.