US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| VARUBI | EQ 90MG BASE | tablet · oral | TERSERA | Prescription | 1 Sep 2015 |
| VARUBI | EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) | emulsion · intravenous | TERSERA | Discontinued | 25 Oct 2017 |
EMA European Union — centrally authorised medicines
Varuby TESARO Bio Netherlands B.V. · Withdrawn · authorised 19 Apr 2017 · ATC A04AD
Therapeutic indication (EMA)
Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.Varuby is given as part of combination therapy.
Safety signals and safety-related labeling changes
- US FDA 19 Aug 2020 VARUBI — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 19 Aug 2020 VARUBI — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
All safety entries for rolapitant →
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.