Committed to communicating safety updates

Three types of safety data will be communicated as soon as updates become available

Data from controlled clinical trials and the open-label extension

  • This long-term safety data is rigorously collected from all clinical trials, including Phase II, III, IIIb, and IV trials, as well as the open-label extension
Data from controlled clinical trials and the open-label extension presented at major MS congresses and published in journals.

Communication channel:

Presented at major MS congresses and published in journals

Postmarketing requirements

  • This is longitudinal safety data from the postapproval safety study (PASS) and other postmarketing requirements (PMRs)
Postmarketing requirements in future publications.

Communication channel:

Future publications

Individual adverse event reports

  • These reports are individually volunteered and reported to Genentech, the FDA, and MedWatch
Individual adverse event reports are thoroughly investigated. Validated reports will be communicated by Genentech.

Communication channel:

Each report is thoroughly investigated. Validated reports will be communicated by Genentech

The Prescribing Information is the primary source of information on OCREVUS. Genentech provides safety updates to health authorities responsible for determining potential label updates. Genentech will ensure that relevant safety updates are communicated to the healthcare community.

For additional safety information, please see accompanying full Prescribing Information and Medication Guide.