Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Mirvaso   
Auth. number : EU/1/13/904
Active substance : brimonidine
ATC: Anatomical main group: D - Dermatologicals
Therapeutic subgroup: D11 - Other dermatological preparations
Pharmacological subgroup: D11A - Other dermatological preparations
Chemical subgroup: D11AX - Other dermatologicals
Chemical substance: D11AX21 - brimonidine
(See WHO ATC Index)
Indication: Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.
Marketing Authorisation Holder: Galderma International
Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/02/2014 Centralised - Authorisation EMEA/H/C/2642 (2014)1313 of 21/02/2014
24/09/2014 Centralised - Variation EMEA/H/C/2642/IB/2
Updated with Decision(2015)3811 of 02/06/2015
04/06/2015 PSUSA - Modification EMEA/H/C/2642 (2015)3811 of 02/06/2015
23/11/2015 PSUSA - Modification EMEA/H/C/2642/PSUSA/10093/201502 (2015)8290 of 19/11/2015
15/11/2016 PSUSA - Modification EMEA/H/C/2642/PSUSA/10093/201602 (2016)7423 of 11/11/2016
16/12/2016 Centralised - Variation EMEA/H/C/2642/IB/9
Updated with Decision(2017)3748 of 24/05/2017
12/01/2017 Centralised - Variation EMEA/H/C/2642/IB/11
Updated with Decision(2017)3748 of 24/05/2017
20/02/2017 Centralised - Variation EMEA/H/C/2642/IAIN/12/G
Updated with Decision(2017)3748 of 24/05/2017
30/05/2017 PSUSA - Modification EMEA/H/C/2642/PSUSA/10093/201608 (2017)3748 of 24/05/2017
26/04/2018 Centralised - Variation EMEA/H/C/2642/II/17