Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Picato   
Auth. number : EU/1/12/796
Active substance : ingenol mebutate
ATC: Anatomical main group: D - Dermatologicals
Therapeutic subgroup: D06 - Antibiotics and chemotherapeutics for dermatological use
Pharmacological subgroup: D06B - Chemotherapeutics for topical use
Chemical subgroup: D06BX - Other chemotherapeutics
Chemical substance: D06BX02 - ingenol mebutate
(See WHO ATC Index)
Indication: Picato is indicated for the cutaneous treatment of non hyperkeratotic, non hypertrophic actinic keratosis in adults.
Marketing Authorisation Holder: LEO Laboratories Ltd
285 Cashel Road, Crumlin, Dublin 12, Ireland
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
19/11/2012 Centralised - Authorisation EMEA/H/C/2275 (2012)8481 of 15/11/2012
21/11/2013 Centralised - Variation EMEA/H/C/2275/II/2
Updated with Decision(2015)205 of 15/01/2015
19/01/2015 Centralised - Yearly update (2015)205 of 15/01/2015
25/06/2015 Centralised - Variation EMEA/H/C/2275/II/13
Updated with Decision(2015)5576 of 31/07/2015
4/08/2015 Centralised - 2-Monthly update EMEA/H/C/2275/II/12 (2015)5576 of 31/07/2015
27/04/2016 PSUSA - Modification EMEA/H/C/2275/PSUSA/10035/201507 (2016)2624 of 25/04/2016
15/11/2016 PSUSA - Modification EMEA/H/C/2275/PSUSA/10035/201601 (2016)7401 of 11/11/2016
30/01/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2275/T/22 (2017)533 of 26/01/2017
24/04/2017 PSUSA - Modification EMEA/H/C/PSUSA/10035/201607 (2017) 2770 of 20/04/2017
17/07/2017 Centralised - Renewal EMEA/H/C/2275/R/23 (2017)5085 of 13/07/2017