This is a summary of the European public assessment report (EPAR) for Mirvaso. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Mirvaso.
For practical information about using Mirvaso, patients should read the package leaflet or contact their doctor or pharmacist.
Mirvaso : EPAR - Summary for the public (PDF/82.2 KB)
First published: 14/03/2014
Last updated: 14/03/2014
Mirvaso : EPAR - Risk-management-plan summary (PDF/83.75 KB)
First published: 13/05/2014
Last updated: 13/05/2014
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
La Défense 4
20 avenue André Prothin
92927 La Défense Cedex
18/01/2022 Mirvaso - EMEA/H/C/002642 - IB/0030
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.
Other dermatological preparations
Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.