Ocrevus (ocrelizumab)
- Region
- 🇪🇺 EU
- Active substance
- ocrelizumab
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis
- CHMP opinion
- Thu 09 Nov 2017
- EU approval
- Mon 08 Jan 2018
- Application
- EMEA/H/C/004043
- ATC
- L04AG08
- Official record
- www.ema.europa.eu
Indication
Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.
Regulatory milestones
Ocrevus (ocrelizumab): DHPC sent to healthcare professionals
Adverse event, Post-authorisation measure; Multiple Sclerosis · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.