Varuby (rolapitant)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- rolapitant
- Company
- TESARO Bio Netherlands B.V.
- Status
- Withdrawn
- Therapeutic area
- Vomiting; Nausea; Cancer
- CHMP opinion
- Wed 22 Feb 2017
- EU approval
- Wed 19 Apr 2017
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004196
- ATC
- A04AD
- Official record
- www.ema.europa.eu
Indication
Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.Varuby is given as part of combination therapy.
Regulatory milestones
No milestones recorded in the last year.
Follow Varuby
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.