Varuby
rolapitant
Table of contents
Overview
The marketing authorisation for Varuby has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Varuby
|
| Agency product number |
EMEA/H/C/004196
|
| Active substance |
rolapitant
|
| International non-proprietary name (INN) or common name |
rolapitant
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
A04AD
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
TESARO Bio Netherlands B.V.
|
| Revision |
3
|
| Date of issue of marketing authorisation valid throughout the European Union |
19/04/2017
|
Product information
11/03/2019 Varuby - EMEA/H/C/004196 - T/0015
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antiemetics and antinauseants
Therapeutic 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.