Frequently asked questions

Roche is committed to transparent, timely communication of adverse events associated with the use of ocrelizumab in the treatment of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This website is intended to serve as just one of the ways we will provide up-to-date, verified safety information to healthcare professionals (HCPs). We will also be providing safety information routinely through publications and presentations at major multiple sclerosis (MS) congresses.

This website is not a comprehensive source of safety information on ocrelizumab. Due to the nature of post-marketing adverse event reports, information may be duplicated and/or incomplete. Some of the investigations remain ongoing, and therefore the information is subject to change.  Additionally, the existence of an adverse event report does not establish causation. We evaluate these reports through our drug safety department, and attempt to verify the information wherever possible. The local prescribing information from your country is the primary source of information on the known and potential risks associated with ocrelizumab.

An adverse event is an untoward medical occurrence in a patient or participant in a clinical investigation, but does not necessarily have a causal relationship with an administered treatment. A post-marketing adverse event report is a report received by Roche regarding an adverse event in a patient taking one of our marketed products.

Following the launch of the searchable FDA Adverse Event Reporting System (FAERS) public dashboard, Roche and Genentech received multiple inquiries regarding spontaneously reported fatalities and PML in patients who received ocrelizumab in the post-marketing setting. To address these inquiries and provide timely, accurate information, Roche created this website. This website serves as just one of the ways in which we plan to communicate safety information. We welcome the FDA’s public dashboard, and share their vision for data transparency.

Robust global systems are in place to continuously monitor the safety of a drug from the time it is first evaluated in clinical studies through commercialisation. All adverse event reports received by Roche are reviewed, assessed, and due diligence is performed. The reports are then submitted to regulatory authorities as per regulatory requirements.

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.

The current plan is for the website to be updated quarterly.

You may contact 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.