Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Picato   
Auth. number : EU/1/12/796
INN : 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 Pharma A/S
Industriparken 55, DK-2750 Ballerup, Danmark

  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/02