Empliciti (elotuzumab)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- elotuzumab
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 28 Jan 2016
- EU approval
- Wed 11 May 2016
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/003967
- ATC
- L01FX08
- Official record
- www.ema.europa.eu
Indication
Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).
Regulatory milestones
No milestones recorded in the last year.
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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.